Overweight and obesity in relation to socio-economic status, tobacco smoking and plant food supplements usage

UNIVERSIDAD DE LAS PALMAS DE GRAN CANARIA INSTITUTO UNIVERSITARIO DE INVESTIGACIONES BIOMÉDICAS Y SANITARIAS DEPARTAMENTO DE CIENCIAS CLÍNICAS PROGRAMA DE DOCTORADO SALUD PÚBLICA (EPIDEMIOLOGÍA, PLANIFICACIÓN Y NUTRICIÓN) TESIS DOCTORAL “Overweight and obesity in relation to socio-economic status, tobacco smoking and plant food supplements usage” Alicia García Álvarez Director de Tesis: Prof. Dr. Lluis Serra-Majem Las Palmas de Gran Canaria, Mayo de 2015 3 AGRADECIMIENTOS/AGRAÏMENTS ACKNOWLEGEMENTS A mi director, Lluís Serra Majem, por tantas cosas, entre ellas: por acogerme en su grupo de investigación hace años; por apoyarme en mis planes de hacer el máster; por plantar en mi mente la idea de hacer un doctorado; por confiar en mí más que yo misma; por su respeto, entendiendo mis necesidades vitales durante estos años; por su generosidad, facilitando siempre el camino con sus ideas y sus bases de datos. Finalmente, por su amistad, físicamente distante pero profundamente sincera. To my director, Lluís Serra Majem, for so many things, among them: for welcoming me in his research group years ago; for supporting me in my plans to do the masters course; for planting in my mind the idea of doing a PhD; for trusting in me more than I trusted myself; for respecting me, understanding my personal needs during these years; for his generosity, always paving the way with his ideas and his databases. Finally, for his friendship, physically distant but deeply sincere. Me gustaría continuar mis agradecimientos siguiendo el orden de los capítulos. I would like to continue my acknowledgements following the order of the chapters. En el capítulo 1, parte del análisis es de mi tesis de maestría en la London School of Hygiene and Tropical Medicine (2004-2005), que fue supervisada por el catedrático Ricardo Uauy. Muchas gracias profesor, por sus esclarecedores e inspiradores consejos. D'altra banda, aquest treball ha estat possible gràcies al finançament de la Agència de Salut Pública (abans Direcció General de Salut Pública) del Departament de Salut de la Generalitat de Catalunya, a través d'un acord de recerca amb la Fundació per a la Investigació Nutricional (FIN). Per tant, moltes gràcies als membres del Grup de Recerca sobre l'Avaluació i Seguiment de la Situació Nutricional de la Població Catalana. Un agraïment especial a la Lourdes Ribas Barba per facilitar-me les dades “físicament”. In Chapter 1, part of the analysis belongs to my MSc thesis at the London School of Hygiene and Tropical Medicine (20042005), which was supervised by Professor Ricardo Uauy. Thank you so much Professor, for your enlightening and inspiring advice. Moreover, this work was possible thanks to the financing of the General Division of Public Health of the Generalitat of Catalonia’s Department of Health, through a research agreement with the Fundación para la Investigación Nutricional (FIN) (Nutrition Research Foundation). Therefore, many thanks to the members of the Research Group on the Evaluation and Monitoring of the Nutritional Status in the Catalan Population. Special thanks to Lourdes Ribas Barba for “physically” facilitating the data. En el capítulo 2, mi sincero agradecimiento a Michelle Mendez, quien co-dirigió y supervisó el análisis, comentó los borradores y reeditó algunas de sus secciones; gracias Michelle por tu paciencia durante mi aprendizaje y por insistir en la importancia de una metodología exhaustiva en el trabajo científico. Un cop més moltes gràcies a Lourdes Ribas Barba per facilitarme les dades. In Chapter 2, my sincere gratefulness to Michelle Mendez, who co-directed and supervised the analyses, commented on drafts and reedited sections of it; thank you Michelle for your patience during my learning and for insisting on the importance of a thorough methodology in the scientific work. Again many thanks to Lourdes Ribas Barba for facilitating the data. En el capítulo 3 (y 4), gracias a todos mis compañeros (y sus equipos) del Work Package 1 -el cual tuve el honor de coordinardentro del Proyecto Europeo PlantLIBRA: por el enorme trabajo realizado In Chapter 3 (and 4), thanks to all my colleagues (and their teams) of Work Package 1 -  which I had the honor of coordinatingwithin the PlantLIBRA EU Project: for the enormous work carried out Agradecimientos/Agraïments/Acknowledgements 4 durante los 3 años que duró proyecto, por hacer posible la encuesta, por su contribución a la publicación de los primeros resultados (PLoS ONE), y por su amistad y todos los conocimientos que he adquirido a través de sus experiencias individuales; a Lourdes Ribas Barba i Raimon Milà Villarroel (FIN), per l’anàlisi de les dades; a Liliana Vargas Murga (FIN), por la elaboración de materiales, pruebas con el cuestionario y revisión de datos, así como por transmitirme su pasión por las plantas medicinales; a Blanca Román-Viñas, Joy Ngo y Blanca Raido (FIN) por su asistencia en las pruebas del cuestionario, manejo y revisión de los datos; y a European Fieldwork Group por llevar a cabo el trabajo de campo de la encuesta. during the 3 years of project, for making possible the survey, for their contribution to the publication of its first results (PLoS ONE), and for their friendship and all the knowledge I have gained through their individual expertise; to Lourdes Ribas Barba and Raimon Milà Villarroel (FIN), for analysing the data; to Liliana Vargas Murga (FIN), for the elaboration of material, questionnaire testing and data review, as well as by transmitting her passion for medicinal plants; to Blanca Román-Viñas, Joy Ngo and Blanca Raidó (FIN) for assistance in questionnaire testing, data handling and data review; and to the European Fieldwork Group for carrying out the survey fieldwork. En el capítulo 4, a Raimon Milà Villarroel, por su tiempo y ayuda con todos los análisis. Finalmente, gracias a todas aquellas personas que fueron entrevistadas, y cuya colaboración hizo posible la realización de estas encuestas. In Chapter 4, to Raimon Milà Villarroel, for his time and help with all the analyses. Finally, thanks to all those persons who were interviewed, and whose collaboration made the realization of these surveys possible. Deixant de banda els capítols, m'agradaria també agraïr les meves companyes de la FIN i també amigues, la Lourdes Ribas Barba, la Joy Ngo de la Cruz i la Blanca Román Viñas, pel seu suport i companyia durant tots aquests anys. No me olvido tampoco de la ayuda de Cristina Ruano, Mariela Nisselsohn y Jorge Doreste, compañeros de la ULPGC. Outside the chapters, I would like to thank my colleagues and friends Lourdes Ribas Barba, Joy Ngo de la Cruz, and Blanca Román Viñas, for their support and company all these years. I also thank my ULPGC colleagues Cristina Ruano, Mariela Nisselsohn and Jorge Doreste. Mi más profundo agradecimiento es para mi familia: el meu marit Joan Calzada, pel seu amor, paciència, suport, per èsser el millor exemple de la determinació, la voluntat i el treball dur en l'assoliment de metes personals; mi hijo Marcel y mi hija Camila, los dos milagros de mi vida, que me obligan a disfrutar del presente y me hacen valorar aún más la salud; mis padres Elena y Gregorio y mis hermanos Elena, Goyo, María, Sandro, Laura y Antonio, por su compañía y por ser los primeros pilares de mi universo; la meva sogra, Lidia Aymerich, pel seu ajut incansable. Querida familia, vuestro amor es mi fuerza. My deepest gratitude goes to my family: my husband Joan, for his love, patience, support, for being the best example of determination, willingness and hard work in achieving personal goals; my son Marcel and my daughter Camila, the two miracles of my life, who help me enjoy the present and make me value health even more; my parents Elena and Gregorio and siblings Elena, Goyo, María, Sandro, Laura and Antonio, for their company and for being the first pillars of my universe; my mother in law, Lidia Aymerich, for her tireless support. Beloved family, your love is my strength. A todos, muchas gracias. To all, thank you so much. A mis padres Elena y Gregorio Que me enseñaron a buscar mi camino… Al meu marit Joan Que camina amb mi… A mis hijos Marcel y Camila Que enriquecen cada paso… Executive summary 7 EXECUTIVE SUMMARY 0. Rationale, aim and specific objectives Rationale Overweight and obesity prevalence rates have been increasing worldwide in the last few decades. This is also the case in the adult population from Catalonia, Spain. Overweight and obesity are multi-factorial chronic diseases. There are many strategies used by individuals for body weight control/loss. Although the diets of all sorts and physical activity are the most popular methods, also relevant ones are tobacco smoking (i.e. smokers are reluctant to give up smoking under the fear that they will gain body weight if they do so) and the usage of weight-loss plant food supplements (PFS). This PhD thesis has been motivated by the following questions: 1. What are the prevalence rates of overweight and obesity in the Catalan adult population in two different points in time (1992-1993 and 2002-2003)? 2. Do socioeconomic (occupation and education) and sociodemographic (gender, age and population of residence size) factors relate to these prevalence rates? 3. Do popularly used weight control strategies such as tobacco smoking (in Catalonia) and PFS consumption (in six EU countries) relate to these prevalence rates? Aim This thesis aims firstly to respond to the questions posed on the rationale, with the intention to identify groups within the Catalan adult population who -according to their SES or their smoking habitsmay be more vulnerable to excess body weight and fat. In addition, it aims to ascertain if consuming tobacco or PFS in weight control/loss has any relationship with overweight or obesity. Finally, it aims to contribute to the scientific literature related to overweight and obesity. Specific objectives Executive summary 8 The objectives of research chapter 1 are two: a) to evaluate the trends (1992–2003) of overweight and obesity prevalence rates in the adult population of Catalonia, Spain, and b) to explore the influence of some socio-economic (occupation and education) and socio-demographic (gender, age and population of residence size) variables on these prevalence trends. Research chapter 2 has the objective of showing trends in the relationship between smoking history and overall overweight/obesity, and between smoking history and central fatness in an adult Catalan population. Research chapter 3 has the objective to provide an overview of the characteristics and usage patterns of PFS consumers in six European countries. This chapter also contextualizes the work carried out in chapter 4. Finally, research chapter 4’s objectives are two: a) to provide an overview of the PFS botanical ingredients consumed for “body weight reasons” and by “dieters for overweight/obesity” in six European countries, and b) to explore the relationship between the consumption of these botanical ingredients and the self-reported BMI of their consumers. 1. Background The background section is included to provide an overview of some relevant aspects on the two main research topics: 1.1) Obesity: excess body weight and adiposity and 1.2) Plant food supplements (PFS). Background 1.1 contextualizes research chapters 1 and 2, whereas background 1.2 contextualizes research chapters 3 and 4. 1.1 Obesity: excess body weight and adiposity – an overview Obesity is characterised by altered body composition with increased adiposity. It is a multifactorial chronic disease whose origins involve environmental (related to sedentary habits, inadequate dietary habits and other lifestyle factors) and genetic factors (involving different polymorphisms). Executive summary 9 The International Obesity Task Force (IOTF) and the World Health Organization (WHO) have declared obesity, as the epidemic of the 21st century due to the dimensions acquired within the last few decades, its impact on morbi-mortality, quality of life and related healthcare costs. The WHO recognizes the impact obesity has on the development of the most prevalent chronic diseases in our society: type 2 diabetes, cardiovascular diseases, musculoskeletal pathologies and an increasing number of certain cancers.Increased body weight also leads to the onset of depression, impaired cognitive functions and disorders related to body image, self-esteem, etc, resulting in impaired social interactions. Moreover, it generates important direct and indirect economic costs as well as significant increases in social and health services (medical visits, absenteeism, loss of autonomy, special needs, etc). Prevention of excess body weight/adiposity is essential, requiring a multidisciplinary preventive approach. Section 1.1 includes five subsections that provide an overview of different areas within the study of excess body weight and adiposity, including: the different techniques currently used to measure body weight and fatness (subsection 1.1.1); the body weight an fatness measures used in the present thesis i.e. Body Mass Index (BMI) and Waist Circumference (WC) (subsection 1.1.2); global, European and Spanish overweight and obesity prevalence rates and trends (subsection 1.1.3); the determinants of overweight and obesity (subsection 1.1.4); and the health effects of overweight and obesity (subsection 1.1.5). 1.2 Plant food supplements – relevant aspects The popularity of botanical products is on the rise in Europe, with consumers using them to complement their diets or to maintain health, and products are taken in many different forms (e.g. teas, juices, herbal medicinal products, plant food supplements (PFS). However there is a scarcity of data on the usage of such products at European level. Section 1.2 includes six subsections that provide information on relevant aspects related to the PFS topic for understanding the research carried out on PFS, including: a description of the PlantLIBRA EU project and the PlantLIBRA PFS Consumer Survey 2011-2012 (subsection 1.2.1); the concepts and definitions needed when collecting data on PFS consumption (subsection 1.2.2); an overview of the regulatory aspects Executive summary 16 Human Nutrition (2.416) or 3) Phytotherapy Research (2.397) or 4) Planta Medica (2.339). 4. References This section includes n=298 alphabetically ordered references cited in all the previous sections. 5. Annexes This section contains supplementary information to the different sections of this thesis, including: the recommendations of the WHO 2008 Expert Consultation on waist circumference and waist-hip ratio; the PlantLIBRA PFS Consumer Survey’s screening questionnaire; the PlantLIBRA PFS Consumer Survey’s main questionnaire; and the dissemination material (two published articles, one submitted article and one presented poster). 6. Resumen en castellano de la tesis doctoral: aspectos más relevantes (“Spanish summary of the PhD thesis: most relevant aspects”) This summary in Spanish of the most relevant aspects of the thesis is included in order to comply with the rules of the "Regulations for the preparation, tribunal, defence and evaluation of doctoral theses, Chapter I, Article 2" (Royal Decree 1393/2007), of the University of Las Palmas de Gran Canaria.  Contents Contents 19 Contents  Page Tables 21 Figures 24 Abbreviations 26 0 Rationale, aim and specific objectives 29 1 Background 33 1.1 Obesity: excess body weight and adiposity – an overview 34 1.1.1 Measuring body weight and fatness 35 1.1.2 The body weight an fatness measures used in this thesis 39 1.1.2.1 Body Mass Index 40 1.1.2.2 Waist Circumference 41 1.1.3 Global, European and Spanish overweight and obesity prevalence rates and trends 45 1.1.4 Environmental determinants of overweight and obesity 58 1.1.5 Health effects of overweight and obesity 60 1.2 Plant Food Supplements – relevant aspects 64 1.2.1 Concepts and definitions to consider when collecting data on PFS consumption 64 1.2.2 The PlantLIBRA project and the PlantLIBRA PFS Consumer Survey 2011-2012 69 1.2.3 Regulatory aspects of PFS 72 1.2.4 PFS market data in EC Member States 74 1.2.5 The weight management industry: past, present and future 78 1.2.6 Classification of botanical products in body weight loss 79 2 Research 83 2.1 Chapter 1: Obesity and overweight trends in Catalonia, Spain (1992-2003): gender and socio-economic determinants 85 2.1.1 Introduction 87 2.1.2 Materials and methods 88 2.1.3 Results 90 2.1.4 Discussion 99 2.2 Chapter 2: Trends in the association between smoking history and general/central obesity in Catalonia (1992-2003), Spain 105 Contents 20 2.2.1 Introduction 107 2.2.2 Materials and methods 108 2.2.3 Results 112 2.2.4 Discussion 121 2.3 Chapter 3: Usage of plant food supplements across six European countries: findings from the PlantLIBRA PFS Consumer Survey 2011-2012 127 2.3.1 Introduction 129 2.3.2 Materials and methods 131 2.3.3 Results 136 2.3.4 Discussion 151 2.4 Chapter 4: BMI overweight and obesity in relation to plant food supplements usage in six European countries: results from the PlantLIBRA PFS Consumer Survey 2011-2012 157 2.4.1 Introduction 159 2.4.2 Materials and methods 162 2.4.3 Results 164 2.4.4 Discussion 174 3 Conclusions and original contributions 185 4 References 191 5 Annexes 223 Annex I: WHO 2008 Expert Consultation on waist circumference and waist-hip ratio Annex II: PlantLIBRA PFS Consumer Survey’s screening questionnaire Annex III: PlantLIBRA PFS Consumer Survey’s main questionnaire Annex IV: Articles and posters: IVa. Article - Obesity and overweight trends in Catalonia, Spain (1992-2003): gender and socio-economic determinants IVb. Article - Trends in the association between smoking history and general/central obesity in Catalonia (1992-2003), Spain IVc. Article - Usage of plant food supplements across six European countries: findings from the PlantLIBRA Consumer Survey IVd. Poster - Plant food supplements consumption, body weight control and BMI: results from the PlantLIBRA PFS Consumer Survey 2011-2012 6 Resumen en castellano de la tesis doctoral: aspectos más relevantes Contents 21 Tables Page Table 1 Methods for measuring body composition 36 Table 2 The International Classification of adult underweight, overweight and obesity according to BMI 40 Table 3 WHO cut-off points and risk of metabolic complications 43 Table 4 International Diabetes Federation cut-off points for different ethnic groups 43 Table 5 Combined recommendations of BMI and WC cut-off points made for overweight or obesity, and association with disease risk 45 Table 6 Projected weight management market growth rates, 2014 through 2018 79 Table 7 A summary of the PFS categories that are hypothesized to achieve weight-loss 81 Table 8 Sample characteristics of the two ENCAT surveys 90 Table 9 Mean, standard deviation and percentiles of BMI and WC, by gender, age and survey (ENCAT 1992-93 and ENCAT 2002-03) 92 Table 10 Overweight and obesity prevalence (BMI and WC) by gender, survey year (ENCAT 1992-93 and ENCAT 2002-03), socioeconomic and socio-demographic characteristics 95 Table 11 Overall crude and adjusted overweight and obesity prevalences (BMI and WC), by gender and survey year (ENCAT 1992-93 and ENCAT 2002-03) 98 Table 12 Comparison of general and abdominal obesity prevalence rates from 3 surveys conducted in the population of Catalonia 103 Table 13 Prevalence of overweight, obesity, IR WC and SIR WC, by gender and survey 113 Table 14 Male and female characteristics by survey and cigarette smoking history 114 Table 15 Associations between smoking history and overweight/obesity and increased-risk/substantially-increased-risk WC (IR/SIR WC) 120 Table 16 Validation study results 136 Table 17 Distribution of screened individuals, PFS consumers interviewed and prevalence sample by country and gender 138 Table 18 PlantLIBRA's PFS consumer survey – socio-demographic sample Contents 22 characteristics, overall and by country 138 Table 19 PlantLIBRA's PFS consumer survey – health-related lifestyle sample characteristics, overall and by country 139 Table 20 PlantLIBRA's PFS consumer survey – PFS usage patterns, per product used by a respondent, overall and by gender and age group 141 Table 21 PlantLIBRA's PFS consumer survey – PFS usage patterns, per product used by a respondent, overall and by country 141 Table 22 PlantLIBRA's PFS consumer survey – Characteristics of PFS reported by respondents 144 Table 23 PlantLIBRA’s PFS consumer survey – number and type of products taken, overall distribution and by gender and age group 144 Table 24 PlantLIBRA's PFS consumer survey – number and type of products taken, by country 144 Table 25 PlantLIBRA's PFS consumer survey – PFS dose forms used, per product used by a respondent, overall and by gender and age group 145 Table 26 PlantLIBRA's PFS consumer survey – PFS dose forms, per product used by a respondent, by country 145 Table 27 PlantLIBRA's PFS consumer survey – botanicals used by at least 5 respondents, ordered by the "n of respondents” 148 Table 28 PlantLIBRA's PFS consumer survey – distribution of the overall top40 botanicals’ reported consumption and the ranking of these botanicals when stratified by gender and age group 149 Table 29 PlantLIBRA's PFS consumer survey – ranking of the overall top-40 botanicals’ reported consumption when stratified by country 150 Table 30 Sample characteristics, overall and by response to question on reasons to take the PFS product (did not respond "body weight", responded “body weight”) 166 Table 31 Top 20 botanicals contained in the PFS taken by “consumers who did not respond ‘body weight’" and by those who “did respond ‘body weight’" when asked for the reasons to take the product 169 Table 32 Top 20 botanicals contained in the PFS taken by consumers who are not and those who are "dieting for overweight/obesity" 170 Table 33 Top 10 botanicals contained in the PFS taken by consumers who “responded body weight" when asked for the reasons to take the Contents 23 product and who were simultaneously "dieting for overweight/obesity" 171 Table 34 BMI distribution differences between consumers and nonconsumers of the top 5 botanicals consumed by those who responded “body weight reasons” for PFS use, when using a) the “body weight” subsample and b) the entire survey sample 172 Table 35 BMI distribution differences between consumers and nonconsumers of the top 5 botanicals consumed by “dieters for overweight/obesity”, when using a) the “dieters for overweight/obesity” subsample and b) the entire survey sample 173 Contents 24 Figures Page Figure 1 Prevalence of overweight*, ages 20+, age standardized. Both sexes, 2008 47 Figure 2 Prevalence of obesity*, ages 20+, age standardized. Both sexes, 2008 48 Figure 3 Overweight prevalence in adults aged 20+ years (age standardized), by WHO Region, gender and income level 50 Figure 4 Obesity prevalence in adults aged 20+ years (age standardized), by WHO Region 50 Figure 5 Overweight prevalence in adults aged 20+ years (age standardized), by income level 51 Figure 6 Obesity prevalence in adults aged 20+ years (age standardized), by income level 51 Figure 7 Countries with the largest overweight and obese populations, 2013/2018 52 Figure 8 WHO’s most recent overweight prevalence (%) in adults aged 20+ years, by European country 54 Figure 9 WHO’s most recent adult obesity prevalence (%) in adults aged 20+ years, by European country 55 Figure 10 Mean BMI in Europe by sex 56 Figure 11 Population breakdown by BMI category in each country (men and women combined) 57 Figure 12 Deaths attributed to 19 leading risk factors, in 2004 61 Figure 13 From the botanical to the PFS 64 Figure 14 Classification of plant-based products 65 Figure 15 Characteristics of PFS 68 Figure 16 Composition and classification of PFS 68 Figure 17 Decision tree to identify a PFS 69 Figure 18 Countries and cities participating in the PlantLIBRA PFS Consumer Survey 71 Figure 19 Mean BMI by gender, age and survey year (ENCAT 1992-93 and 2002-03) 93 Figure 20 Mean WC by gender, age and survey year (ENCAT 1992-93 and 2002-03) 93 Figure 21 Prevalence of BMI categories in male (top) and female (bottom) Contents 25 never smokers, former smokers and current smokers, by Survey. ENCAT 1992-1993 and 2002-2003 116 Figure 22 Prevalence of WC categories in male (top) and female (bottom) never smokers, former smokers and current smokers, by Survey. ENCAT 1992-1993 and 2002-2003 117 Figure 23 PFS products taken for "body weight" (%), by country 167 Figure 24 PFS Consumers dieting for overweight/obesity (%), by country 167 Figure 25 Number of Cynara scolymus (artichoke)-containing PFS used for body weight and other health reasons, by country 174 Background 1: Obesity 33 1. BACKGROUND This section introduces the main research objectives developed in the thesis. Section 1.1 shows the importance of the problems of overweight and obesity (excess body weight and adiposity) in today's society. Obesity and overweight are defined, weight and body fat measuring techniques are explained, and indicators of overall weight and abdominal fat used in the empirical analysis (Body Mass Index –BMIand Waist Circumference -PC) are described. Prevalence rates and trends of overweight and obesity at global, European and Spanish level are also shown; determinants of overweight and obesity and the effects that overweight and obesity have on health are summarized. All these aspects have been extensively described in numerous articles and therefore only a summary of the main inputs is presented in order to contextualize the contributions that are made in research chapters 1, 2 and 4 of the thesis. In these chapters the relationship between obesity and overweight and socio-economic and socio-demographic characteristics of the population (chapter 1), smoking history (chapter 2), and consumption of plant food supplements (PFS) (chapter 4) is analyzed. Chapters 1 and 2 of the thesis have used population samples and datasets obtained from the Catalan Nutrition Surveys (ENCAT 1992-1993 and 2002-2003). The characteristics of these surveys are not described in this introductory section, since they have been widely described in numerous scientific articles published in international journals. The most relevant publications of ENCAT have been cited in the methodological sections of chapters 1 and 2. Furthermore, this section pays special attention to describing the PlantLIBRA Consumer Survey 2011-2012. This survey was conducted within the framework of the European Project PlantLIBRA, in which the Foundation for Nutritional Research-FIN participated. The survey was conducted under the leadership of Professor Lluís Serra Majem and it was coordinated by the author of this thesis. Its data have been used in this thesis to analyze the consumption of PFS in 6 countries of the European Union (EU) (chapter 3) and to analyze the relationship between BMI and PFS use (chapter 4). The main reason for including a detailed description of the survey is that its development is very recent and there are few articles that have used it. It is also important to note that to date there is very little literature that analyzes the consumption of PFS, their marketing and the profile of the consumers of these products. Finally, the development of the survey and the creation of this database is considered an important methodological contribution of this thesis. Background 1: Obesity 34 With this in mind, section 2.2 introduces various concepts and definitions used in the preparation of survey material, it describes the methodology used and explains the main features of the database. Moreover, the relevant aspects of the PFS market and its regulation, the evolution of the body weight control industry in recent years and the classification of the botanicals used in weight control/loss are also described. 1.1 Obesity: excess body weight and adiposity – an overview Obesity is characterised by altered body composition with increased adiposity. When applying the analysis of body composition, cases of obesity are defined when percentages of adipose tissue are above 33% in women and over 25% in men (SerraMajem & Bautista 2013). Obesity is a multifactorial chronic disease whose origins involve environmental and genetic factors (Serra-Majem & Bautista 2013; Varela-Moreiras et al. 2013). A high percentage of obesity cases show a clear environmental component (related to sedentary habits, inadequate dietary habits and other lifestyle factors) that causes a positive energy balance and, as a consequence, the gradual accumulation of fatty tissue. From the genetics perspective, it is currently known that obesity is a polygenic disease. Moreover there is an incomplete understanding of its physiopathology, for which it is difficult to discern the role of the different polymorphisms and their interaction with environmental factors (Serra-Majem & Bautista 2013). The International Obesity Task Force (IOTF) and the World Health Organization (WHO) have declared obesity, as the epidemic of the 21st century due to the dimensions acquired within the last few decades, its impact on morbi-mortality, quality of life and related healthcare costs. WHO recognizes the impact obesity has on the development of the most prevalent chronic diseases in our society: type 2 diabetes, cardiovascular diseases, musculoskeletal pathologies and an increasing number of certain cancers. Moreover, increased body weight also leads to the onset of depression, impaired cognitive function (Varela-Moreiras et al. 2013) and disorders related to body image, self-esteem, etc, resulting in impaired social interactions (SerraMajem & Bautista 2013). There is increasing emphasis on the distribution of abdominal fat and its role in increasing cardiovascular risk. Background 1: Obesity 35 Obesity in a society results in important direct and indirect economic costs, as well as significant increases in social and health services (medical visits, absenteeism, loss of autonomy, special needs, etc) (Serra-Majem & Bautista 2013; Varela-Moreiras et al. 2013). Prevention of excess body weight/adiposity is essential since once the obesity level is reached by an individual, it is associated with a large degree of therapeutic failures and the tendency towards relapse (Serra-Majem & Bautista 2013). A multifactorial disease such as obesity requires a multidisciplinary preventive approach (Varela-Moreiras et al. 2013). 1.1.1 Measuring body weight and fatness Power et al. suggested that “an ideal measure of body fat should be accurate in its estimate of body fat; precise, with small measurement error; accessible, in terms of simplicity, cost and ease of use; acceptable to the subject; and well documented, with published reference values”. They further comment that “no existing measure satisfies all these criteria” (Power, Lake & Cole 1997; Lobstein, Baur & Uauy 2004). Adiposity is measured using a range of settings and methods. There are both direct and indirect methods for assessing and evaluating fatness: - Direct measures of body composition provide an estimation of total body fat mass and several components of fat free mass. Such techniques include underwater weighing, magnetic resonance imaging (MRI), computerized axial tomography (CT or CAT) and dual energy X-ray absorptiometry (DEXA). The methods are used predominantly for research and in tertiary care settings, but may be used as a “gold standard” to validate anthropometric measures of body fatness (Goran 1998). - Indirect measures refer to the anthropometric measures of relative adiposity include among others waist, hip and other girth measurements, skinfold thickness and indices derived from measured height and weight such as Quetelet’s index (BMI or W H-2), the ponderal index (W H-3) and similar formulae. All anthropometric measurements rely to some extent on the skill of the person taking the measure, and their relative accuracy as a measure of adiposity must be validated against a ‘gold standard’ measure of adiposity (Lobstein, Raur & Uauy 2004). Background 1: Obesity 36 Table 1 includes a brief description of these direct and indirect methods, as well as comments on the strengths and weaknesses of these different methods used for population and clinical judgements. Table 1. Methods for measuring body composition. Method Description Comments: advantages (A) and disadvantages (D) Direct measures Underwater weighing (hydro-densitometry) Fat has a lower density than lean tissue, and by measuring the density of the whole body the relative proportions of each component can be determined. If total body density and the specific densities of fat and fatfree mass are known, an equation can be generated for converting total body density to percentage body fat (Goran 1998). (D): Requires a person to hold their breath underwater, and is unsuitable for use in young children or in older subjects who lack water confidence. There are theoretical concerns about the assumptions used to translate density measurements into estimates of fat mass and fat-free mass, both among normal children and the obese. Magnetic resonance imaging (MRI) MRI provides a visual image of adipose tissue and non-fat tissue. Total body fat volume, total fat mass and percentage fat mass can be estimated. (A): MRI can accurately and reliably distinguish intra-abdominal from subcutaneous fat. (D): MRI is expensive, time consuming and must be performed in a major medical facility. The procedure takes approximately 20 min, and requires the subject to lie still, enclosed in a scanner, and may be unsuitable for young children. Computerized tomography (CT) CT scans produce highresolution X-ray-derived images and can identify small deposits of adipose tissue. Total and regional body fat can be calculated, as well as percentage body fat. (A): The procedure allows intraabdominal and subcutaneous fat to be quantified with a high degree of accuracy and reliability. (D): The equipment is expensive and must be operated by a skilled technician. The procedure involves significant radiation exposure, takes 20 min and requires the subject to lie still within the scanner, so is unsuitable for routine use in children unless clinically indicated. Background 1: Obesity 37 Table 1. Continued. Dual-Energy X-ray Absorptiometry (DEXA) DEXA is based on the principle that transmitted X-rays at two energy levels are differentially attenuated by bone mineral tissue and soft tissue, and the soft tissue component is subdivided into fat and lean tissue by using experimentally derived calibration equations (Goran et al.1996). (A): It has a high correlation with CT scan data in determining total fat mass (Goran et al.1998). The procedure delivers lower radiation exposure than CT and is thus more suitable for use in children and adolescents. (D): DEXA cannot distinguish between intra-abdominal and subcutaneous fat. The test must be performed in a major medical facility with the DEXA equipment, the equipment is expensive and must be operated by a skilled technician, and the procedure may take up to 20 min and requires a very cooperative subject, therefore making it unsuitable for children aged less than 6 years. DEXA has not been fully evaluated in healthy child or adolescent populations or in very obese people. Bioelectrical impedance analysis (BIA) BIA is not strictly a direct measure of body composition, being based on the relation between the volume of a conductor (the body), the conductor’s length (height) and its electrical impedance (Wells 2001). BIA assumes fat mass is anhydrous and that conductivity reflects fat-free mass. Prediction equations estimate the fat-free mass from the measured impedance and, by subtraction, the fat mass. (A): BIA measurements can be taken quickly and inexpensively, it is relatively non-invasive and has high interand intra-observer reliability. (D): It requires equations specific to the instrument used and for the population under investigation, and the measurement may vary with hydration status and ethnic status (Wabitsch et al. 1996). Although gaining acceptance in a range of settings, the limitations of BIA are sometimes overlooked. Air-displacement plethysmography A subject’s volume is determined indirectly by measuring the volume of air the subject displaces when sitting inside an enclosed chamber. Adjustment for thoracic gas volume is made. Once body volume and mass are known, the principles of densitometry are applied to estimate percentage body fat. (A):Air-displacement plethysmography measurements are comfortable, relatively quick, non-invasive and can accommodate a wide range of body types. (D): Subjects should be reasonably cooperative (for accurate measurement the subject should breathe through a tube and wear a nose clip) and hence the technique may be unsuitable for younger children. Again, there are theoretical concerns about the assumptions used to calculate body fat (Fields et al. 2002). Background 1: Obesity 38 Table 1. Continued. Indirect measures Body mass index (BMI) BMI is defined as weight (kg) /height squared (m 2 ), and is widely used as an index of relative adiposity among children a , adolescents and adults. Among adults, the WHO recommends that a person with a BMI of 25 kg m-2 or above is classified overweight, while one with a BMI 30 kg m-2 or above is classified obese (WHO 2000) although revisions of these guidelines are being proposed for certain populations (Deurenberg-Yap et al. 2002). For children, various cut-off criteria have been proposed based on reference populations and different statistical approaches. (A): BMI is more accurate when height and weight are measured by a trained person rather than self-reported. Measurement of height and weight has a high subject acceptance, which is particularly important for adolescents who may be reluctant to undress (measures are normally taken in light clothing, without shoes). There is low observer error, low measurement error and good reliability and validity. (D): BMI may not be a sensitive measure of body fatness in people who are particularly short, tall or have an unusual body fat distribution, and may misclassify people with highly developed muscles. Hence two people with the same amount of body fat can have quite different BMIs (Sardinha et al. 1999). There may also be racial differences in the relationship between the true proportion of body fat and BMI (Wang et al. 1994). Waist circumference (WC) and Waist-tohip ratio (WHR) WC is an indirect measure of central adiposity. Central adiposity is strongly correlated with risk for cardiovascular disease in adults (Ross et al. 1996) and an adverse lipid profile and hyperinsulinaemia in children (Freedman et al. 1999). WC is measured at the minimum circumference between the iliac crest and the rib cage using an anthropometric tape. W-to-hip ratio has been used among adults to identify people with high central adiposity. WC is measured as above and hip circumference is measured at the maximum protuberance of the buttocks. The ratio is then calculated. (A): Waist and hip circumferences are easy to measure with simple, low-cost equipment, have low observer error, offer good reliability, validity and low measurement error. (D): There are no accepted cutoff values for the classification of overweight and obesity based on these measures, and there have been few studies of the relation between central adiposity and the metabolic disturbances associated with excess visceral fat among children and adolescents. WC and hip circumference are highly age dependent, and it is not recommended to use the ratio between them without first considering each measure separately (Power et al. 1997). Background 1: Obesity 39 Table 1. Continued. Skin-fold thickness Skin-fold thickness can be measured at different sites on the body (e.g. triceps, subscapular) using skin-fold callipers. Prediction equations can then be used to estimate fat mass and percentage fat from the skin-fold measurements. New methods for measuring skin fold using portable echography equipment are under development. (A): Skin-fold thickness uses simple equipment and offers only a moderate respondent burden, and has the potential to determine total body fat and regional fat distribution. (D): Skin-fold thickness varies with age, sex and race, and the equations relating skin-fold thickness at several sites to total body fat need to be validated for each population. Measurement requires training and intraand inter-observer reliability is poor (Wells 2001). In very obese individuals the measurement of triceps skin-fold or other skin-fold thicknesses may not be possible. The relationship with metabolic problems is unclear. Other anthropometric measures: 1) the Ponderal Index; 2) the Conicity Index; 3) The Body Shape Index. Various alternatives to the weight-to-height ratio have been developed examining different powers of N in the formula weight/heightN, such as the Ponderal Index (w h -3 ). ‘N’ is sometimes referred to as the Benn index. The Conicity Index, is defined as WC/(0.109 x square root of weight/height). The Body Shape Index (ABSI) is the most recent index defined as WC/BMI 2/3 height 1/2 . (A): 1) and 2) measures have high subject acceptance and there is low observer error, low measurement error and good reliability and validity; 3) Body shape, as measured by ABSI, appears to be a substantial risk factor for premature mortality in the general population derivable from basic clinical measurements. ABSI expresses the excess risk from high WC in a convenient form that is complementary to BMI and to other known risk factors (Krakauer 2012). (D): 1) and 2) measures - as with BMI, height and weight are more accurate when measured by a trained person rather than self-reported; 3) More cohorts are needed to delineate the limits of ABSI’s utility and further studies about ethnic specificities of ABSI are needed and warranted (He & Chen 2013). None of these indices is widely used at present. Source: adapted from Lobstein et al. 2004. a For children, various cut-off criteria have been proposed based on reference populations and different statistical approaches (Lobstein et al. 2004). 1.1.2 The body weight and fatness measures used in this thesis  Overweight and obesity occur when excess fat accumulates in the human body, posing a risk to health. Despite the limitations mentioned in the previous section, current definitions are based on both the BMI and the WC (ICO 2010). A gain in body weight or WC is indicative of increasing health risk.   Background 1: Obesity 40 1.1.2.1 Body Mass Index The “Quetelet index” – as it was known until 1972, when Ancel Keys (1904-2004) termed it the “Body Mass Index” (Keys et al. 1972)-, was described in 1832 by the Belgian mathematician Adolphe Quetelet (Eknoyan 2007) and it is a measure for human body shape based on an individual's mass and height. The WHO defines the BMI as “a simple index of weight-for-height that is commonly used to classify underweight, overweight and obesity in adults”; Table 2 includes the international classification of adult underweight, overweight and obesity according to BMI that has been proposed by the WHO (WHO 1998; WHO 2014: BMI). It is defined as the “weight in kilograms divided by the square of the height in metres (kg/m 2 )”. For example, an adult who weighs 80kg and whose height is 1.80m will have a BMI of 24.7. BMI = 80 kg/(1.80 m 2 ) = 80/3.24 = 24.7 kg/m 2 In countries where the weight is measured in pounds and the height in inches, the formula would be adapted as follows: BMI = [weight(lb)/height(in)) 2 ] x 703) Table 2: The International Classification of adult underweight, overweight and obesity according to BMI. Classification BMI (kg/m 2 )  Principal cut-off points Additional cut-off points Underweight <18.50 <18.50 Severe thinness <16.00 <16.00 Moderate thinness 16.00 - 16.99 16.00 - 16.99 Mild thinness 17.00 - 18.49 17.00 - 18.49 Normal weight 18.50 - 24.99 18.50 - 22.99 23.00 - 24.99 Overweight 25.00 25.00 Pre-obese 25.00 - 29.99 25.00 - 27.49 27.50 - 29.99 Obese 30.00 30.00 Obese class I 30.00 - 34.99 30.00 - 32.49 32.50 - 34.99 Obese class II 35.00 - 39.99 35.00 - 37.49 37.50 - 39.99 Obese class III 40.00 40.00 Source: WHO 2014: Global Database on BMI, adapted from WHO 1995, WHO 2000 and WHO expert consultation 2004. Background 1: Obesity 41 Adult BMI values are age-independent and the same for both sexes. However, BMI may not correspond to the same degree of fatness in different populations due, in part, to different body proportions. The health risks associated with increasing BMI are continuous and the interpretation of BMI gradings in relation to risk may differ for different populations (WHO 2014: Global Database on BMI). For example, the interpretation of the BMI cut-offs in Asian and Pacific populations raised a debate due to the increasing evidence that the associations between BMI, percentage of body fat, and body fat distribution differ across these populations and therefore, the health risks increase below the cut-off point of 25 kg/m 2 that defines overweight in the current WHO classification (WHO/IASO/IOTF 2000; James et al. 2002). In order to shed the light on this debate, WHO convened the Expert Consultation on BMI in Asian populations (Singapore, 8-11 July, 2002) (WHO expert consultation 2004). The WHO Expert Consultation concluded that the proportion of Asian people with a high risk of type 2 diabetes and cardiovascular disease is substantial at BMI's lower than the existing WHO cut-off point for overweight (= 25 kg/m 2 ). However, the cut-off point for observed risk varies from 22 kg/m 2 to 25 kg/m 2 in different Asian populations and, for high risk, it varies from 26 kg/m 2 to 31 kg/m 2 . The Consultation, therefore, recommended that the current WHO BMI cut-off points (Table 1) should be retained as the international classification (WHO expert consultation 2004). However, they also recommended that the cut-off points of 23, 27.5, 32.5 and 37.5 kg/m 2 were to be added as points for public health action: therefore, for reporting purposes, and with a view to facilitating international comparisons, countries should use all categories (i.e. 18.5, 23, 25, 27.5, 30, 32.5 kg/m 2 , and in many populations, 35, 37.5, and 40 kg/m 2 ) (WHO expert consultation 2004). A WHO working group was formed by the WHO Expert Consultation (WHO expert consultation 2004) and is currently undertaking a further review and assessment of available data on the relation between WC and morbidity and the interaction between BMI, WC, and health risk (WHO 2014: Global Database on BMI). 1.1.2.2 Waist circumference Waist circumference (WC) has more recently been considered to classify obesity, as the distribution of body fat has been found to be important and carrying it around the abdomen has been found to be especially unhealthy. The WHO defines disease risk on the basis of both BMI and WC (see Table 3). Background 1: Obesity 48 Source: WHO 2011. &ŝŐƵƌĞϮWƌĞǀĂůĞŶĐĞŽĨŽďĞƐŝƚLJΎĂŐĞƐϮϬнĂŐĞƐƚĂŶĚĂƌĚŝnjĞĚŽƚŚƐĞdžĞƐϮϬϬϴ Background 1: Obesity 49 Moreover, the WHO recognizes that overweight and obesity prevalence rates are increasing both in developed and developing societies (Garcia-Alvarez et al. 2006; WHO 2003) and that 65% of the world's population live in countries where overweight and obesity kills more people than underweight (WHO 2013). The WHO has very recently reported a very alarming fact that evidences this increasing trends and compromises global future health: “more than 40 million children under the age of five were overweight in 2011”; and they insist in the statement that obesity is preventable (WHO 2013). The WHO facts and figures are in line with those of the IASO/IOTF which refers to obesity as “the global epidemic”, and whose recent analysis (2010 data) estimates that approximately 1.0 billion adults are currently overweight (BMI 25-29.9 Kg/m²), and a further 475 million are obese. They add that when Asian-specific cut-off points for the definition of obesity (BMI>28 kg/m 2 ) are taken into account, the number of adults considered obese globally is over 600 million. Moreover, globally, IASO/IOTF estimate that up to 200 million school-aged children are either overweight or obese, of those 4050 million are classified as obese (IASO/IOTF 2012). The GHO also reported the 2008 prevalence of overweight and obesity by WHO region (WHO 2009). Figures 3 and 4 show that the prevalence rates of overweight and obesity were highest in the WHO Regions of the Americas (62% for overweight in both sexes, and 26% for obesity) and lowest in the WHO Region for South East Asia (14% overweight in both sexes and 3% for obesity). In the WHO Region for Europe and the WHO Region for the Eastern Mediterranean and the WHO Region for the Americas over 50% of women were overweight (Figure 3). For all three of these regions, roughly half of overweight women were obese (23% in Europe, 24% in the Eastern Mediterranean, 29% in the Americas) (Figure 4). Moreover, in all WHO regions women were more likely to be obese than men. In the WHO regions for Africa, Eastern Mediterranean and South East Asia, women had approximately twice the obesity prevalence of men. Background 1: Obesity Figure 3. Overweight p by W Source: A dapted fro m Figure 4. Obesity pr e Source: A dapted fro m In addition, the GHO repor t level of countries up to u p diets and too little physic a common cluster of risk fa c 2007). In 2008, the preval e countries was more than t 5). Regarding obesity, the d Ϭ ϭϬ ϮϬ ϯϬ ϰϬ ϱϬ ϲϬ ϳϬ &Z  йŽǀĞƌǁĞŝŐŚƚƉŽƉƵůĂƚŝŽŶ Ϭ ϱ ϭϬ ϭϱ ϮϬ Ϯϱ ϯϬ ϯϱ &Z йŽďĞƐĞƉŽƉƵůĂƚŝŽŶ 50 p revalence in adults aged 20+ years (age stan d HO Region, gender and income level. m WHO’s Global Health Observatory (WHO, 200 9 e valence in adults aged 20+ years (age standa r by WHO Region m WHO’s Global Health Observatory (WHO, 200 9 t s that the prevalence of elevated BMI incre a p per middle income levels (WHO 2009).O b a l activity are often linked to each other a n c tors among people with low versus higher e nce of overweight in high income and upp e wice that of low and lower middle income c d ifference more than tripled from 7% obesit y  DZ DZ hZ ^Z tWZ t,KZĞŐŝŽŶ DĞ tŽ Žƚ DZ DZ hZ ^Z tWZ t,KZĞŐŝŽŶ D t  Ž d ardized), 9 ), year 2008. r dized), 9 ), year 2008. a ses with income b esity, unhealthy n d to a far more incomes (WHO e r middle income c ountries (Figure y in both sexes in Ŷ ŵĞŶ Ś^ĞdžĞƐ D ĞŶ t ŽŵĞŶ Ž ƚŚ^ĞdžĞƐ lower middle income countries Obesity among women was income countries where it women’s obesity was approximately Figure 5. Overweight prevalence in adults aged 20+ years Source: Adapted from WHO’s Global Health Observatory Figure 6. Obesity prevalence in adults aged 20+ years Source: adapted from WHO’s Global Health Observatory And the future does not augur more than 40 million children under the age of five were overweight. Once considered 0 10 20 30 40 50 60 70 Low income % overweight population 0 5 10 15 20 25 30 35 Low income % obese population Background 1: Obesity 51 countries to 24% in upper middle income countries was significantly higher than among men, it was similar. In low and lower middle income approximately twice that of men. Overweight prevalence in adults aged 20+ years (age standardized) by income level. WHO’s Global Health Observatory (WHO 2009), year 2008. Obesity prevalence in adults aged 20+ years (age standardized) by income level. WHO’s Global Health Observatory (WHO 2009) , year 2008. augur better expectations. According to the WHO, i more than 40 million children under the age of five were overweight. Once considered Low middle income Upper middle income High income Income level Men Women Both Sexes Low middle income Upper middle income High income Income level Men Women Both Sexes Background 1: Obesity countries (Figure 6). except for high income countries (age standardized) , year 2008. (age standardized) , , year 2008. better expectations. According to the WHO, i n 2011, more than 40 million children under the age of five were overweight. Once considered Women Both Sexes Men Women Both Sexes Background 1: Obesity 52 a high-income country problem, overweight and obesity are now on the rise in lowand middle-income countries, particularly in urban settings. More than 30 million overweight children are living in developing countries and 10 million in developed countries (WHO 2013). Figure 7 shows that by 2018, more than 3 out of 4 people aged 15 and older are projected to be overweight or obese in Kuwait, Venezuela, and Mexico, as well as in the United States (Euromonitor International 2014a). Figure 7. Countries with the largest overweight and obese populations, 2013/2018 Source: Euromonitor International 2014a. As seen earlier, this is a major cause for concern since being overweight or obese is linked to a series of health complications and is directly responsible for 2.8 million deaths a year according WHO. European data The WHO has reported that overweight affects 30-80% of adults in the countries of the European Region (WHO Regional Office for Europe 2007; WHO 2011; WHO Regional Office for Europe 2013). Also that more than 20% of children and adolescents are overweight, and one third of these are obese, alerting that the trend in obesity is especially alarming among children and adolescents. The annual rate of increase in the prevalence of childhood obesity has been growing steadily and the current rate is 10 Background 1: Obesity 53 times that in the 1970s (WHO Regional Office for Europe 2007; WHO 2011; WHO Regional Office for Europe 2013). This contributes to the obesity epidemic among adults and creates a growing health challenge for the next generation. Figure 8 shows WHO’s most recent adult overweight prevalence rates of both sexes of 34 European countries. Bearing in mind the data’s limitations, it can be observed that sixteen countries have a prevalence rate equal or higher than 50% - with Germany having the highest rate; sixteen have a rate ranging between 40 and 50%; and only two have a rate between 30 and 40%. Background 1: Obesity 54 Figure 8. WHO’s most recent overweight prevalence (%) in adults aged 20+ years, by European country. *UKGB&NI: The United Kingdom of Great Britain & Northern Ireland. **FYRM: The Former Yugoslav Republic of Macedonia. Source: adapted from WHO’s data (WHO 2014)Country comparison - BMI adults % overweight (>=25.0), Most recent. Caveat: The national BMI data displayed in this graphs are empirical and have been verified that they apply internationally recommended BMI cut-off points. However, it is important to note that the data presented are not directly comparable since they vary in terms of sampling procedures, age ranges and the year(s) of data collection. ϲϲϱ ϰϵϯ ϯϳϯ Ϭ ϭϬϮϬϯϬϰϬϱϬϲϬϳϬ 'ĞƌŵĂŶLJ ŽƐŶŝĂĂŶĚ,ĞƌnjĞŐŽǀŝŶĂ DĂůƚĂ ƌŽĂƚŝĂ h<'ΘE/Ύ &zZDΎΎ 'ƌĞĞĐĞ /ƌĞůĂŶĚ dƵƌŬĞLJ ^ĞƌďŝĂΘDŽŶƚĞŶĞŐƌŽ WŽƌƚƵŐĂů ^ƉĂŝŶ ,ƵŶŐĂƌLJ WŽůĂŶĚ >ŝƚŚƵĂŶŝĂ ĐĞĐŚZĞƉƵďůŝĐ &ƌĂŶĐĞ &ŝŶůĂŶĚ /ĐĞůĂŶĚ ^ůŽǀĂŬŝĂ LJƉƌƵƐ ƵůŐĂƌŝĂ >ĂƚǀŝĂ ^ǁĞĞĚĞŶ ĞůŐŝƵŵ EŽƌǁĂLJ /ƚĂůLJ ƐƚŽŶŝĂ ƵƐƚƌŝĂ EĞƚŚĞƌůĂŶĚƐ ZŽŵĂŶŝĂ ĞŶŵĂƌŬ ^ǁŝƚnjĞƌůĂŶĚ >ƵdžĞŵďŽƵƌŐ хсϱϬϬ ϰϬϬͲϱϬϬ ϯϬϬͲϰϬϬ WƌĞǀĂůĞŶĐĞƌĂŶŐĞ Background 1: Obesity 55 In addition, Figure 9 shows WHO’s most recent adult obesity prevalence rates in 34 European countries. Six countries have a prevalence rate in the range of 20-30%, with the Former Yugoslav Republic of Macedonia taking the lead. Figure 9. WHO’s most recent adult obesity prevalence (%) in adults aged 20+ years, by European country. *FYRM: The Former Yugoslav Republic of Macedonia. **UKGB&NI: The United Kingdom of Great Britain & Northern Ireland. Source: adapted from WHO’s data (WHO 2014). Country comparison - BMI adults % obese (>=30.0), Most recent Caveat: The national BMI data displayed in this graphs are empirical and have been verified that they apply internationally recommended BMI cut-off points. However, it is important to note that the data presented are not directly comparable since they vary in terms of sampling procedures, age ranges and the year(s) of data collection. Ϯϱϭ ϭϵϳ ϵϴ Ϭ ϱ ϭϬ ϭϱ ϮϬ Ϯϱ ϯϬ &zZDΎ h<'ΘE/ΎΎ 'ƌĞĞĐĞ ƌŽĂƚŝĂ ŽƐŶŝĂĂŶĚ,ĞƌnjĞŐŽǀŝŶĂ DĂůƚĂ >ŝƚŚƵĂŶŝĂ WŽůĂŶĚ ,ƵŶŐĂƌLJ ^ĞƌďŝĂΘDŽŶƚĞŶĞŐƌŽ &ƌĂŶĐĞ dƵƌŬĞLJ &ŝŶůĂŶĚ ^ƉĂŝŶ >ĂƚǀŝĂ ĐĞĐŚZĞƉƵďůŝĐ ^ůŽǀĞŶŝĂ ƐƚŽŶŝĂ ^ůŽǀĂŬŝĂ WŽƌƚƵŐĂů /ƌĞůĂŶĚ 'ĞƌŵĂŶLJ /ĐĞůĂŶĚ ƵůŐĂƌŝĂ LJƉƌƵƐ ^ǁĞĞĚĞŶ ĞŶŵĂƌŬ ƵƐƚƌŝĂ ĞůŐŝƵŵ EŽƌǁĂLJ EĞƚŚĞƌůĂŶĚƐ /ƚĂůLJ >ƵdžĞŵďŽƵƌŐ ZŽŵĂŶŝĂ ^ǁŝƚnjĞƌůĂŶĚ ϮϬϬͲϯϬϬ ϭϬϬͲϮϬϬ ϱϬͲϭϬϬ WƌĞǀĂůĞŶĐĞƌĂŶŐĞ Background 1: Obesity 56 According to the IASO/IOTF, in the European Union (EU) 27 member states, approximately 60% of adults and over 20% of school-age children are overweight or obese. This equates to around 260 million adults and over 12 million children being either overweight or obese (IASO/IOTF 2014). Using data from Eurobarometer 59.0 (European Commission 2003), de Saint Pol reported the male and female mean BMI in 15 European countries (Figure 10), as well as thepopulation breakdown by BMI category in each country (Figure 11) (de Saint Pol 2009). The United Kingdom had the highest female mean BMI, whereas Greece had the highest male mean BMI. Again, Greece and the United Kingdom had the greatest proportion of obesity and overweight. Figure 10. Mean BMI in Europe by sex. Source: de Saint Pol 2009; European Commission 2003: Eurobarometer 59.0. Note: mean BMI of European men is higher than that of women, except in the United Kingdom and the Netherlands. Background 1: Obesity 57 Figure 11. Population breakdown by BMI category in each country (men and women combined). Source: de Saint Pol 2009; European Commission 2003: Eurobarometer 59.0. Note: The proportion of obese is under-estimated in some countries due to reporting bias. Spanish data In Spain, several studies have coincided in that adult, adolescent and child obesity prevalence has also increased in the last decades (Serra-Majem et al. 2003; ArancetaBartrina et al. 2005). They have recognized that the group of children aged between 6 and 13 years and the group of women aged over 45 years are the groups with the highest risk of obesity; moreover, obesity prevalence is higher among males during years of growth and development (Serra-Majem et al. 2003; Aranceta-Bartrina et al. 2005), while in the over 45-year group it is significantly higher in females (GutiérrezFisac et al. 1994; Aranceta-Bartrina et al. 2005). In a study in Southern Spain, the authors found that a larger proportion of men were overweight compared to women, but the opposite was found for obesity (Mataix et al. 2005). In 2004, the results from the DORICA Study (Aranceta et al. 2004) showed that the obesity prevalence of the North-Eastern region of Spain (which includes Catalonia) was 8.5% for men and 13.8% for women, which were the lowest out of the eight regions included in the study (Aranceta-Bartrina et al. 2005). Background 2: PFS 64 1.2 Plant food supplements – relevant aspects The popularity of botanical products is on the rise in Europe, with consumers using them to complement their diets or to maintain health, and products are taken in many different forms (e.g. teas, juices, herbal medicinal products, plant food supplements (PFS). However there is a scarcity of data on the usage of such products at European level. This section presents a background on some relevant topics related to plant food supplements (PFS) that will provide a context for better understanding the research presented in both Chapters 3 and 4. 1.2.1 Concepts and definitions to consider when collecting data on PFS consumption When collecting data on PFS consumption it is essential to have all relevant concepts and definitions harmonized. This section summarises the main concepts and definitions used in the work carried out during the conduction of the PlantLIBRA PFS Consumer Survey 2011-2012. Origen and definition of a PFS In order to have a general idea of where PFS derive from, Figure 13 shows a route that botanicals follow to arrive to the dose form of PFS. Figure 13. From the botanical to the PFS. ŽƚĂŶŝĐĂů WůĂŶƚ ůŐĂĞ &ƵŶŐŝ >ŝĐŚĞŶ ŽƚĂŶŝĐĂů ƐƵďƐƚĂŶĐĞƐ ZŽŽƚƐ ZŚŝnjŽŵĞƐ dƵďĞƌƐ ^ƚĞŵƐ >ĞĂǀĞƐ &ůŽǁĞƌƐ &ƌƵŝƚƐ ^ĞĞĚƐ ŽƚĂŶŝĐĂů ƉƌĞƉĂƌĂƚŝŽŶƐ džƚƌĂĐƚƐ ƐƐĞŶƚŝĂůŽŝůƐ džƉƌĞƐƐĞĚũƵŝĐĞƐ WƌŽĐĞƐƐĞĚ ĞdžƵĚĂƚĞƐ WƌĞƐƐĞĚŽŝůƐ WůĂŶƚĨŽŽĚ ƐƵƉƉůĞŵĞŶƚ ĚŽƐĞĨŽƌŵ ĂƉƐƵůĞƐ;ŚĂƌĚ ĂŶĚƐŽĨƚͿ >ŝƋƵŝĚƐ;ĚƌŽƉƐ ƐLJƌƵƉƐͿ WŽǁĚĞƌ dĂďůĞƚƐƉŝůůƐ 'ƌĂŶƵůĞƐ ;ƐĂĐŚĞƚƐǀŝĂůƐͿ The differences between b PFS can be derived from t h •Botanical: Consists o f physiological effect. Botan according to the binomial s •Botanical substances * broken plants, parts of pla n in dried form, but sometim e specific treatment are also *Note: Can also be referre d •Botanical preparation substances to treatments purification, concentration expressed juice, etc. Botanical substances and generally designed as pl classified as food, medicin e Figure  A “plant-based product” i s botanical ingredients. Th i B 65 b otanicals, botanical substances, botanical p h e following definitions: f plants, algae, fungi or lichens that have icals are precisely defined by the botanica l s ystem (genus, species, variety and author). * : Derived from botanicals, are mainly whol e n ts, algae, fungi or lichens in an unprocess e e s fresh. Certain exudates that have not be e considered to be botanical substances. d to as “plant parts used” or “plant used porti o s: Used in PFS, are obtained by subj e such as extraction, distillation, expressi o or fermentation. These include extracts botanical preparations are included in di f ant-based products for human consumpt i e or homeopathic product (Figure 14). 14. Classification of plant-based products. s any product intended for human consu m i s includes herbal teas/tisanes, condime n ackground 2: PFS p reparations and a nutritional or l scientific name e , fragmented, or e d state - usually e n subjected to a o ns”. e cting botanical o n, fractionation, , essential oils, f ferent products, i on, and further  m ption that has n ts/spices, PFS, Background 2: PFS 66 herbal medicinal products and herbal homeopathic products. As these products might be confused with PFS, the definition of each of them as given below: • Herbal 3 teas/tisanes: Consist of one or more botanical substances intended for oral aqueous preparations by means of decoction, infusion or maceration. Herbal teas are usually supplied in bulk form or in sachets and prepared immediately before use. The term “herbal teas” is also used to designate instant soluble preparations (tisanes) also obtained by means of decoction, infusion or maceration. Usually, infusion is appropriate for leaves, flowers and delicate parts whereas decoction or maceration is appropriate for roots, rhizomes and barks. These preparations are usually consumed as beverages. • Condiments/spices: Are classified as plants or botanical substances, fresh or dried, whole, fragmented or powdered, for their colour, aroma or flavour characteristics. They are used to prepare food and beverages to incorporate these features so as to make them products more palatable and tasty and thus enhancing their better consumption. • Plant food supplement: According to the Directive 2002/46/EC (European Parliament & Council 2002), food supplement is defined as “foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop-dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities”. This definition includes the general statement “concentrated sources of nutrients or other substances”, which, for the purpose of the PlantLIBRA PFS Consumer Survey was replaced by the specific term “botanical preparations” (the adapted definition is included in Chapter 3). • Herbal medicinal products (see definition of “herb” in footnote 3): Any product used for a medicinal purpose, exclusively containing one or more herbal substances or one   ϯ Definition of "herb": The term "herb" has more than one definition. Botanists describe an herb as a small, seed bearing plant with fleshy, rather than woody, parts (from which we get the term "herbaceous"). According to The Herb Society of America's New Encyclopaedia of Herbs and Their Uses (Bown 2001), the term refers to a far wider range of plants. In addition to herbaceous perennials, herbs include trees, shrubs, annuals, vines, and more primitive plants, such as ferns, mosses, algae, lichens, and fungi. They [herbs] are valued for their flavour, fragrance, medicinal and healthful qualities, economic and industrial uses, pesticidal properties, and colouring materials (dyes)."  Background 2: PFS 67 or more herbal preparations as active ingredients, or one or more such herbal substances in combination with one or more such herbal preparations. These products have two important characteristics: they have a therapeutic effect and need marketing authorisation. • Homeopathic products (including herbal-based): Are prepared from botanical, zoological o human substances (of natural or synthetic origin), products or preparations called stocks, in accordance with a homeopathic manufacturing procedure. A homeopathic preparation is usually designated by the Latin name of the stock, followed by an indication of the degree of dilution. Characteristics, composition and classification of PFS PFS have the following characteristics (illustrated in Figure 15): they are concentrated sources of botanical preparations, i.e. they must include botanical preparations, e.g. pressed oil of Evening primrose seed. Moreover, PFS can contain only botanical(s) or botanical(s) in combination with other ingredients (see classification in Figure 16, which presents two other important aspects of PFS), e.g. only Evening primrose seed oil or this oil combined with vitamin E. Also, they are marketed in dose form, e.g. Evening primrose seed oil marketed as soft capsules. Furthermore, they are designed to be taken in measured small unit quantities, i.e. the soft capsules of Evening primrose seed oil will be taken in a recommended dose with a frequency and a duration period. In addition, they are meant to supplement the normal diet, e.g. Evening primrose seed oil would be an additional source of essential fatty acids. Lastly, they have nutritional or physiological effects, e.g. Evening primrose seed oil can be recommended for its nutritional and/or health benefits. Background 2: PFS 68 Figure 15. Characteristics of PFS. Figure 16. Composition a and classification b of PFS. a.PFS are composed of “must” ingredients and “other possible ingredients”; b.PFS can be classified in different ways, according to (among others): the “chemical nature” of their ingredients and their “effect”. W>Ed&KK ^hWW>DEd ŽŶĐĞŶƚƌĂƚĞĚƐŽƵƌĐĞ ŽĨďŽƚĂŶŝĐĂů ƉƌĞƉĂƌĂƚŝŽŶƐ ŽƚĂŶŝĐĂůŽŶůLJ;ŽŶĞŽƌŵŽƌĞ ďŽƚĂŶŝĐĂůƉƌĞƉĂƌĂƚŝŽŶƐͿŽƌ ŽƚĂŶŝĐĂůŝŶĐŽŵďŝŶĂƚŝŽŶ ǁŝƚŚ ŽƚŚĞƌŝŶŐƌĞĚŝĞŶƚƐ DĂƌŬĞƚĞĚŝŶĚŽƐĞ ĨŽƌŵ ;ĞŐĐĂƉƐƵůĞƐ ƉŝůůƐƚĂďůĞƚƐ ƐĂĐŚĞƚƐĞƚĐͿ ĞƐŝŐŶĞĚƚŽďĞ ƚĂŬĞŶŝŶŵĞĂƐƵƌĞĚ ƐŵĂůůƵŶŝƚ ƋƵĂŶƚŝƚŝĞƐ ^ƵƉƉůĞŵĞŶƚƐƚŚĞ ŶŽƌŵĂůĚŝĞƚ tŝƚŚŶƵƚƌŝƚŝŽŶĂůŽƌ ƉŚLJƐŝŽůŽŐŝĐĂůĞĨĨĞĐƚ ŽŵƉŽƐŝƚŝŽŶ ůǁĂLJƐĐŽŶƐŝƐƚŽĨ ͻ ŽƚĂŶŝĐĂůƉƌĞƉĂƌĂƚŝŽŶƐ ͻ WůĂŶƚͲĚĞƌŝǀĞĚďŝŽĂĐƚŝǀĞ ƐƵďƐƚĂŶĐĞƐ ͻ WůĂŶƚͲĚĞƌŝǀĞĚĞƐƐĞŶƚŝĂů ĨĂƚƚLJĂĐŝĚƐ DĂLJĂůƐŽĐŽŶƚĂŝŶ ͻsŝƚĂŵŝŶƐ ͻDŝŶĞƌĂůƐ ͻ WƌŽďŝŽƚŝĐƐƉƌĞďŝŽƚŝĐƐ ͻ ŝŽĂĐƚŝǀĞƐƵďƐƚĂŶĐĞƐ ͻ ƐƐĞŶƚŝĂůĨĂƚƚLJĂĐŝĚƐ ͻ ĞĞƉƌŽĚƵĐƚƐ;ƉƌŽƉŽůŝƐ ƉŽůůĞŶŚŽŶĞLJͿ ůĂƐƐŝĨŝĐĂƚŝŽŶ ŽƚĂŶŝĐĂůŽŶůLJ ͻ KŶůLJŽŶĞďŽƚĂŶŝĐĂů ƉƌĞƉĂƌĂƚŝŽŶ ͻ dǁŽŽƌŵŽƌĞďŽƚĂŶŝĐĂů ƉƌĞƉĂƌĂƚŝŽŶƐ ŽƚĂŶŝĐĂůŝŶĐŽŵďŝŶĂƚŝŽŶ ǁŝƚŚ ͻ KŶĞŽƌŵŽƌĞďŽƚĂŶŝĐĂů ƉƌĞƉĂƌĂƚŝŽŶƐнŵŝŶĞƌĂů ͻ KŶĞŽƌŵŽƌĞďŽƚĂŶŝĐĂů ƉƌĞƉĂƌĂƚŝŽŶƐнǀŝƚĂŵŝŶƐ ͻ KŶĞŽƌŵŽƌĞďŽƚĂŶŝĐĂů ƉƌĞƉĂƌĂƚŝŽŶƐнǀŝƚĂŵŝŶƐ нŵŝŶĞƌĂůƐ ͻ KƚŚĞƌĐŽŵďŝŶĂƚŝŽŶ Background 2: PFS 69 Identification of a PFS in the market PFS are very specific products and it is not easy to identify them in a market where many other herbal products are used. A decision tree was used -together with all the above informationto train the interviewers during the participant recruitment process of the survey, presented in Figure 17. Figure 17. Decision tree to identify a PFS. 1.2.2 The PlantLIBRA project and the PlantLIBRA PFS Consumer Survey 20112012 The popularity of botanical products is on the rise in Europe, with consumers using them to complement their diets or to maintain health (e.g. body weight control), and products are taken in many different forms (e.g. teas, juices, herbal medicinal products, No Yes The product is not a Plantbased product Does the product contain one or more botanicals (plant, algae, fungi, lichen)? No Yes o No No Yes Yes Is the product used for cooking or seasoning? Is the product by itself considered a beverage? Is the botanical preparation diluted? Herbal teas/tisanes Condiments/species Homeopathic products Does the product have a therapeutic effect or a marketing authorisation? No Yes Plant food supplements Herbal medicinal products Background 2: PFS 70 PFS). However there is a scarcity of data on the usage of such products at European level. PlantLIBRA (acronym of “PLANT Food Supplements: Levels of Intake, Benefit and Risk Assessment” - EC contract no. 245199) (www.plantlibra.eu/web) is a four-year research project (2011-2014) co-financed by the EC within the context of the 7 th EU Framework Program, that aimed to foster the safe use of food supplements containing plants or botanical preparations, by increasing science-based decision-making by regulators and food chain operators. The project was also structured to develop new methodologies and tools for risk and benefit assessment of PFS. PlantLIBRA was carried out by an international consortium of 25 partners, including 8 academic centres, 7 public research institutions and national food safety agencies, 6 non-profit bodies or foundations, 3 smalland medium-sized enterprises involved in research and regulation and one private sector enterprise, and spans 4 continents: Europe, Asia (China), South America (Argentina and Brazil) and Africa (South Africa). The project was organized into 11 work packages (WP). The main activity of WP1 consisted of conducting a survey to assess the consumption of PFS. The PlantLIBRA PFS Consumer Survey 2011-2012 was conducted by 6 partner centres from the 6 European countries in which it was conducted: Finland, Germany, Italy, Romania, Spain and the United Kingdom. Fieldwork lasted over 15 months, from May 2011 to August 2012. Data were collected from 2359 PFS consumers residing in 24 European cities (4 per country) (Figure 18). A 5-minute questionnaire was used initially to identify consumers of PFS in the previous 12 months (see Annex II). Those considered “eligible consumers” who were also willing to participate completed a 30minute questionnaire during an interview about their PFS usage. This questionnaire consisted of 58 questions, 20 of which asked about aspects of PFS usage, and 38 asked about socio-demographic, health and lifestyle aspects (see Annex III). Survey results have provided data to assess the socio-demographic profile of PFS users, the usage patterns of these products, the actual products consumed and their botanical ingredients. Figure 18. Countries and It is important to describ e analysis. In order to prope r at the level of all three t h databases were built a n “consumer” database, and first two databases were i n ones. The “products-bota n the product such as PR O used as the variable that botanicals contained in t botanicals and the cons u code for each producer/la b PRODUCT TYPE (single o contained in the product) name). The “consumer d a questionnaire (Annex III). consumed (up to a maxi m questionnaire. Each of the corresponded to the produ to obtain information on th e B 71 cities participating in the PlantLIBRA PFS Co n e how the data have been organized int o r ly assess the consumption of PFS in the sel e h e product, the botanical and the consume r n d used: 1) the “products-botanicals” d a 3) the merged database of “consumers an d n itially built in each country and then merge d n icals” database contained collected basic i n O DUCT CODE (identification code for each allowed knowing the main features of the hem, and hence, it was included in bot h u mer databases), MANUFACTURER CO D b orator y /distributor/brand), FORM (consum p o r multi-botanical), PLANT NUMBER (num b and PLANT CODE (identification code fo r a tabase” was developed from the survey P F In this database, information was collected m um of five products per respondent, as products consumed was identified with a c o ct code of the products-botanicals databas e e total number of botanicals consumed by e a ackground 2: PFS n sumer Survey.  o databases for e cted population r , three different a tabase, 2) the d products”. The d into two global n formation about product: it was product and the h the productsD E (identification p tion dose form), b er of botanicals r each botanical F S consumption on the products included in the o de number that e . Lastly, in order a ch participant in Background 2: PFS 72 the survey, a new database was generated with all the information contained in the database of products-botanicals and all the information contained in the consumers database. The merging of the two database files was performed using the product code as the connecting link. The aim was to link each product registered as consumed by the survey participants with the data contained in the products-botanicals database, and the product code allowed this matching. With this step, the final database was obtained, which contained in the same one file the respondents data and the data of the products consumed by the respondent. The first generated database file contained a total of 3698 variables, since each of the five (per-consumer) potentially consumed products was assigned the 491 botanical code variables of the products-botanicals database (491x5=2455 variables, plus 1243 variables from the questionnaire=3698). The next step was to generate a new ID code for each of the botanicals and the number of the consumed product (out of the five possible). Since the aim of the study was not to determine the amount of consumed botanicals, but rather whether or not a certain botanical was consumed, all botanical variables for each of the five products were unified in a single variable to identify whether or not the botanical had been consumed regardless of the order number of the product it came from. Thus, the database was reduced to a total of 1937 variables. Further methodological details are provided in Chapter 3’s Materials and Methods section, including the definitions used for a PFS product and of a PFS consumer, the sample distribution, survey instruments and their administration for data collection, and data preparation for analysis. 1.2.3 Regulatory aspects of PFS Plants or botanicals are being used in many products, including foods, food supplements, medicinal products, cosmetics, biocides, etc. All these different products have their specific legal framework. For example, in the food area, plants are used for seasoning and taste; plants are also used for their health properties, in particular in herbal teas and food supplements; in medicinal products, plants are used for a therapeutic purpose (Larrañaga–Guetaria 2012).  Background 2: PFS 73 In the EU, it is a general principle that a plant or botanical can be used both in foods/food supplements and in medicinal products, depending on the purpose (health or therapeutic) and in agreement with specific rules regarding safety (Larrañaga– Guetaria 2012). The EU legal system does not set out any kind of authorization procedure centralised at EU level for the use of botanicals and derived preparations in food. Nonetheless, the use of botanicals and derived preparations in food has to comply with the general requirements set out in the Regulation laying down general principles and requirements of food law and creating the European Food Safety Authority (EFSA) (Regulation (EC) No 178/2002). This, among other things, assigns primary legal responsibility for the safety of the products placed on the market to business operators (EFSA 2012). In other words, it is the manufacturer who decides what legal framework to use depending on the use intended for the product, and once this choice is made, he is responsible for applying the relevant legal requirements in a correct way (Larrañaga–Guetaria 2012). Food supplements are regulated by Directive 2002/46/EC, known as the Food Supplements Directive, and may be marketed within the Community only if they comply with the rules laid down in this directive. (European Parliament & Council 2002) The objective of the document was to harmonize EC rules across Member States, but does not provide for substances other than vitamins and minerals, such as amino and fatty acids, fibers, plants and plant extracts, to be used in food supplements and they continue being regulated by various national decrees, which need to be observed when marketing PFS. These national legislations differ widely. Some Member States have regulated the use of botanicals in detail, based on negative lists of plants the use of which is not allowed and/or positive lists of plants that are accepted to be used. Some apply specific conditions of use (e.g. maximum levels, warning statements) (Larrañaga–Guetaria 2012). But in most Member States, the manufacturer or the person placing the product on the market in the particular territory is obliged to notify the competent authorities of these activities by forwarding a model of the label used. This process is free of charge in some European countries (Vargas-Murga et al. 2011). In some case, such information must include specific technical data on the composition and nature of the product. Such information may be assessed by specific national scientific advisory bodies (Larrañaga–Guetaria 2012). Despite this multitude of national rules, a basic European ‘principle of mutual recognition’ applies, by which any product that is lawfully marketed in one Member State can be sold in all 27 Member States. But this principle of mutual recognition is Background 2: PFS 80 hypothesized mechanism of action for reducing weight or changing body composition (Manore 2012): 1) Products that block the absorption of fat or carbohydrate, thus decreasing the amount of energy absorbed from food 2) Stimulants that increase metabolism 3) Products hypothesized to alter nutrient partitioning, thus changing body composition by decreasing body fat while increasing lean tissue ͶȌ Products that suppress appetite or increase satiety so that less energy is consumed.  Table 7 briefly covers each category, giving examples of botanical ingredients used in PFS and discussing proposed mechanisms of action and potential side effects described in the literature. Many weight-loss supplements combine multiple ingredients from these categories into one product, which makes testing for efficacy and safety difficult (Manore 2012). Background 2: PFS 81 Table 7. A summary of the PFS categories that are hypothesized to achieve weight-loss. Weight-loss supplement category Examples of botanical ingredient of supplements Proposed mechanisms or use Potential side effects Absorption blockers Phaseolus vulgaris (common bean) Alpha-amylase inhibitor: reduces or prevents carbohydrate digestion and absorption. GI upset, bloating, and gas. No toxicity, based on animal studies (Chokshi 2006). Stimulants Caffeine (from coffee seeds, tea leaves, kola nuts, yerba mate, guarana berries) Increases thermogenesis by inhibiting degradation of cAMP (Diepvens et al. 2007). Effects can be potentiated with ephedra or nicotine. High intakes (300 mg/day) can result in insomnia, irritability, heart palpitations, and anxiety. Camellia sinensis (green tea (GT) or its extract) Active ingredients are caffeine and catechins, especially EGCG. May increase thermogenesis, Reduce lipogenesis, and decrease fat absorption or increase fat oxidation. Generally regarded as safe if taken as tea. GT extracts have been associated with liver damage, especially if ingested on an empty stomach (Sarma et al. 2008). Disruptors of nutrient partitioning or energy Hydroxycitric acid (HCA), a botanical extract from plants native to India, especially Garcinia cambogia (malabar tamarind) HCA inhibits ATP-citratelyase, the enzyme that leaves citrate into oxaloacetate and acetylCoA for endogenous fat synthesis (Watson et al. 1969; Watson & Lowenstein 1970). HCA may suppress fatty-acid synthesis and food intake while decreasing weight gain. Numerous safety issues including liver injury. In 2009, the FDA warned consumers to stop using Hydroxycut products that contained HCA (Fong et al. 2010). Appetite suppressants Soluble fibers (e.g., psyllium, guar gum, beta glucans, or glucomannan) Soluble fibers hold water and increase satiety and fullness. SCFA can influence production of satiety hormones (Anderson et al. 2009; Hosseini et al. 2011). GI upset, bloating, and gas. Hoodia gordonii (e.g., Hoodia, Kalahari cactus, Xhoba) Native plant of the Kalahari Desert in southern Africa associated with reduced hunger. Appetite suppression Attributed to a plant compound called P57, a steroidal alkaloid (Madgula et al. 2010). Safety is unknown. No published studies. Note. GI=Gastrointestinal; GT=Green tea; EGCG=Epigallocatechin gallate; HCA=Hydroxycitric acid; FDA=Food and Drug Administration; SCFA=short-chain fatty acids. Source: Adapted from Manore 2012. 2. Research 2.1 - Chapter 1:  Obesity and overweight trends in Catalonia, Spain (1992-2003): gender and socio-economic determinants   Research: Chapter 1 87 2.1.1 Introduction Numerous studies have shown that obesity is more frequent in the less socially advantaged population groups, regardless of the variable used to classify socioeconomic status (SES); these differences in the prevalence of obesity by SES have been observed both in men and women, but are stronger and more consistent in women (Sobal & Stunkard 1989). The WHO´s MONICA Study showed that the prevalence of obesity is higher among adults and children of low SES (Molarius et al. 2000). In Spain, in 1987, a group of researchers found a higher prevalence of obesity among the population of a lower educational level (Gutiérrez-Fisac et al. 1994); in the period 1987-1997, the same researchers found a higher obesity prevalence in individuals with elementary education, and that the obesity prevalence proportion associated with elementary education increased in women and decreased in men (Gutiérrez-Fisac et al. 2002). Moreover, the SEEDO´97 Study in Spain showed higher obesity rates in men and women with low educational level, and also that older women with low educational level and low income seemed to be the most susceptible group to weight gain (Aranceta et al. 2001). Adding to this evidence, a significant inverse relationship between SES and overweight and obesity was found by the AVENA (Alimentación y Valoración del Estado Nutricional de los Adolescentes Españoles) Study (Moreno et al. 2005), although only in male adolescents. Overweight and obesity also have a socio-demographic component. In this respect, the SEEDO´97 Study in Spain also showed differences in the distribution of the obesity prevalence by area of residence and geographical zones (Serra-Majem et al. 1996). Other well-known factors that influence the development of obesity are physical inactivity (Jakicic & Otto 2005; Gutiérrez-Fisac et al. 2003), over-consumption of energy-dense diets (which has been shown to be associated to low SES) (Rolls et al. 2005) and genetic factors (although some authors do not agree to this) (Townsend 2006). The objective of this chapter is to evaluate the trends (1992-2003) of overweight and obesity prevalences in the 18-75 year-old population of Catalonia, Spain, and the influence of socio-economic and socio-demographic variables on these prevalence trends. Research: Chapter 1 88 2.1.2 Materials and methods Sample and subjects The data analysed belong to the 1992-93 and the 2002-03 cross-sectional Evaluations of the Nutritional Status of the Catalan Population (ENCAT 1992-93 and ENCAT 200203) (Serra Majem et al. 1996; Serra Majem et al.2006). ENCAT is a regional survey carried out periodically by the Department of Health of the Catalan Government and co-ordinated by the Centre for Research on Community Nutrition of the University of Barcelona. The theoretical random sample population and sample size have been described elsewhere (Serra Majem et al. 1996; Serra Majem et al.2006), comprising the population source of residents in the official census. The samples were stratified according to household and randomized into sub-groupings with municipalities being the primary sample units, and individuals within these municipalities comprising the final sample units. The valid response rate for the first survey was 69% and for the second 65%. Adults from each representative sample within the age of 18-75 years were included in the analysis of this study (n in ENCAT 1992-93=2248 and n in ENCAT 2002-03=1715). Data collection procedures and variables of the study In both surveys, dieticians were trained on standardisation of criteria and methodology before data collection, in order to reduce inter-observer measurement variability. The data were collected from 1992 to 1993 and from 2002 to 2003 through questionnaires and anthropometric measurements during a home interview. In order to analyse the influence of the socioeconomic variables on the prevalence of overweight and obesity, the following variables were used and rearranged according to the following categories (Aranceta et al. 2001): 1. Socioeconomic level (SEL) (occupation of the subject): a) low: the non-classifiable, army, agricultural sector, service sector and non-qualified labourers; b) medium: qualified labourers, foremen, rest of administrative, commercial and technical staff and medium-level technicians; c) high: high–level technicians, directors/managers, selfemployed professionals, business owners or self-employed individuals without staff, business owners or self-employed individuals with staff. Research: Chapter 1 89 2. Education level of the subject and of the family´s head member (ELS and ELH): a) low: primary school incomplete or illiterate (<6 years at school); b) medium: primary school completed, secondary school or further education (6-12 years of education); c) high: high school, college or university degree (>12 years of education). The socio-demographic determinants included: 1) gender, 2) age group (18-24 years, 25-44 years, 45-64 years and 65-75 years) and 3) population of residence size (<10,000 inhabitants; 10,000-100,000 inhabitants, and >100,000 inhabitants). Anthropometric measurements Body Mass Index: weight and height had been measured with a portable spring scale and a metric tape (Kawe© model). The individuals were measured in standardised conditions, wearing underwear and no shoes. Weight was measured in kilograms, scale measurement error +100g. Height was measured standing and head in Frankfurt horizontal position, expressed in centimetres, instrumental measurement error +0.1 cm. BMI was calculated using weight and height and categorized according to WHO criteria (WHO 1998) so that overweight was defined as BMI>25 to BMI<30 kg/m 2 and obesity as BMI>30 kg/m 2 . Waist circumference: it was measured with a non-elastic metric tape halfway between the lower border of the ribs and the iliac crest on a horizontal plane. Measurements were recorded to the nearest 0.1 cm and categorized according to WHO criteria, so that men with a WC 94.0–101.9 cm and women with a WC 80.0–87.9 cm were classified as overweight, and men with a WC>102.0 cm and women with a WC>88.0 cm were classified as obese (WHO 1998). Statistical analysis All analyses were performed with SPSS 12.0. Proportions of overweight and obesity were estimated for each sample separately and stratified by gender and age (to control for its potential confounding effects). The age distribution of the whole Catalan population in 1992-93 was used as a reference. The proportions from the two surveys were compared using the χ 2 statistic test and the means were compared using the ttest, considering p-values <0.05 for significance. Research: Chapter 1 96 When considering the variable “age”, Table 10 shows that in ENCAT 1992-93, the highest prevalence of BMI overweight was found in both males and females aged 4564 years, which was also the case for female but not male WC overweight; while in ENCAT 2002-03, only an increase in female BMI overweight and male WC overweight were observed with progressing age. Regarding obesity, both surveys show an increase in the prevalence of BMI and WC obesity with progressing age in both sexes (note the high prevalence of WC obesity among the eldest men and women in 200203, 49.6 and 70.9% respectively). The between-survey comparison shows significant changes only in male BMI overweight and male WC obesity rates, showing alarming increases in the latter rates (i.e. from 1.3 to 6.0% in the 18-24 year-old group). Regarding the variable “socioeconomic level” (SEL), the differences observed in BMI and WC overweight and obesity prevalences of the different SEL groups were significant only in females of both surveys, WC obesity being highest in the low SEL group (Table 10). In ENCAT 1992-93, SEL was inversely related to the prevalence of BMI obesity, but only significantly in females; this inverse relationship was not observed among SEL groups in ENCAT 2002-03. WC obesity was only inversely related with SEL in females of both surveys and the differences among SEL groups were significant (Table 10). The between-survey comparison shows significant increases in male BMI and WC obesity (from 8.3 to 16.5% and from 13.3 to 26.3%) and female WC obesity (from 15.3 to 19.3%). With regard to the variable “education level of the subjects” (ELS), in ENCAT 2002-03, Table 10 shows an inverse relationship with BMI overweight and obesity prevalence, but with differences among ELS groups only significant in females (note a female BMI obesity prevalence of 36.6% in the low ELS group); this inverse relationship is observed between ELS and male and female WC obesity but not WC overweight (note the high male and female WC obesity rates in the lowest ELS group, 34.3 and 69.5% respectively). The between-survey comparison revealed significant differences in both BMI and WC overweight and obesity for both genders. It is worth noticing that while male and female WC overweight seem to have increased among the highest ELS group (from 15.5 to 23.9% and from 11.8 to 14.9% respectively), female WC obesity prevalence in the lowest ELS group increased by 20 percentage points (from 49.3 to 69.5%). Research: Chapter 1 97 The variable “education level of the family head member” (ELH), showed in ENCAT 2002-03 a significant inverse relationship with BMI overweight, BMI obesity and WC obesity in females (Table 10). Females whose family head member had a medium education level presented the highest WC overweight prevalence compared to females whose family head member had a low or high ELH (23.9% in 1992-93 and 19.0% in 2002-03). The between-survey comparison revealed significant differences in both BMI and WC overweight and obesity for both genders. Male and female BMI overweight, male and female BMI obesity, male WC overweight and male and female WC obesity rates have increased in the low and high ELH groups, while in the medium ELH group the increase was only observed in male BMI overweight (from 9.6 to 17.5%) and male and female WC obesity (from 12.9 to 24.9% and from 23.3 to 30.2% respectively). The difference of 27 percentage points in female WC obesity prevalence in the low ELH group is worth noticing (from 35.1 in ENCAT 1992-93 to 61.9% in ENCAT 2002-03). Regarding “population of residence size”, only ENCAT 2002-03 differences observed in female WC overweight and obesity were significant (“within-survey comparison”, Table 10). The between-survey comparison showed significant differences in all prevalences except for males BMI andWC obesity; it is worth mentioning that, in the <10,000 inhabitants group, while female BMI and WC overweight rates decreased (from 32.5 to 27.8% and from 22.5 to 12.9%, respectively), female BMI and WC obesity rates increased (from 15.6 to 18.0 and from 31.1 to 38.6%, respectively). Table 11 shows how the ENCAT 2002-03 BMI and WC overweight and obesity prevalences change when adjusting by the ENCAT 1992-93 SEL, ELS, ELH and population of residence size distributions. It is apparent that male and female BMI obesity increases to its highest when standardised by the ENCAT 1992-93 ELS and population size (from 16.6 to 17.8% and from 15.2 to 19.6%, respectively), while male and female WC obesity increases to its highest when standardised by the ENCAT 1992-93 ELS (from 24.4 to 26.7% and from 31.1 to 39.2%, respectively). Male and female BMI and WC obesity decreased when adjusted by the ENCAT 1992-93 SEL distribution. Research: Chapter 1 98   Table 11. Overall crude and adjusted overweight and obesity prevalences (BMI and WC), by gender and survey year (ENCAT 1992-93 and ENCAT 2002-03). BMI Overweight a BMI Obesity b WC Overweight a WC Obesity b Males Females Males Females Males Females Males Females 19921993 20022003 19921993 20022003 19921993 20022003 19921993 20022003 19921993 20022003 19921993 20022003 19921993 20022003 19921993 20022003 Variables % % % % % % % % % % % % % % % % Overall crude prevalence 44.1 43.7 29.1 30.1 9.9 16.6 15.0 15.2 21.7 23.8 21.8 17.7 13.1 24.4 24.5 31.1 2002-3 prevalence standardised by 1992-3 SEL c distribution (SR d ) 44.1 44.1 29.1 29.4 9.9 16.5 15.0 13.9 21.7 23.9 21.8 17.5 13.1 24.1 24.5 28.3 2002-3 prevalence standardised by 1992-3 ELS e distribution (SR) 44.1 45.4 29.1 33.4 9.9 17.8 15.0 19.6 21.7 24.7 21.8 17.9 13.1 26.7 24.5 39.2 2002-3 prevalence standardised by 1992-3 ELH f distribution (SR) 44.1 44.3 29.1 31.9 9.9 16.7 15.0 18.6 21.7 24.4 21.8 17.5 13.1 25.2 24.5 36.8 2002-3 prevalence standardised by 1992-3 Pop. Size distribution (SR) 44.1 45.4 29.1 33.4 9.9 17.8 15.0 19.6 21.7 23.7 21.8 17.4 13.1 25.0 24.5 33.0 a. BMI 25 to <30 Kg/m 2 and WC 94 to <102 cm for males and 80 to <88 cm for females, according to WHO classification (1998). b. BMI >30 Kg/m and WC>102 cm for males and > 88 cm for females, according to WHO classification (1998). c. SEL: Socioeconomic Level. d. SR: Standardised Rate. e. ELS: Education level of the subjects. f. ELH: education level of the family head member. Research: Chapter 1 99 2.1.4 Discussion The WHO recognises that the main limiting factors when comparing epidemiological studies on the prevalence of overweight and obesity are: the different criteria to define the cut-offs; the different age groups considered; the time interval for collection of data; and studies comparison based on reported weight and height (WHO 1998). This study is based on the 1992-93 and 2002-03 ENCAT surveys, which were carried out on representative random samples of the Catalan population. Both surveys used the same anthropometric measurement procedures (weight, height and WC were measured instead of reported) and socioeconomic factors, and allow for comparison of the same age groups (18-75 years). The WHO has recommended BMI as a good index of total overweight and obesity (WHO 1998), although it gives no information about body fat distribution, while WC reflects abdominal visceral fat distribution. Nevertheless, the two measures are highly correlated (Sarlio-Lähteenkorva et al. 2006). It has been shown that changes in WC accompany changes in cardiovascular risk factors especially in the elderly (Turcato et al. 2000). Research has also shown that WC can also predict morbidity and mortality, considering it a better measure of obesity than BMI, since it is a simple and easy measurement (Lean et al. 1998); WC is even more strongly associated with metabolic abnormalities and health-care costs than BMI (Sarlio-Lähteenkorva et al. 2006). A single WC measurement has been suggested to be used to identify individuals who should seek and be offered weight management (Lean et al. 1995). We have used both BMI and WC measures to define total and central overweight and obesity in order to have a more complete overall picture of the problem in the Catalan population. This study has shown that in Catalonia, in 2002-03, mean BMI in males was higher than in 1992-93, and that of females was lower (except for the youngest group); on the other hand, overall prevalence of BMI overweight and obesity was 43.7% and 16.6% respectively in males, and 30.1% and 15.2% respectively in females. When comparing these figures with those of the 2002 IOTF report for Spain (1998-2000), we observe that overweight was lower in Catalonia in both genders (in Spain 48% for males and 40% for females), while obesity was higher for Catalan males and females (in Spain 12% and 15% respectively) (IOTF, EASO 2002). Therefore, in terms of gender, this study shows that overweight and obesity are more prevalent in men (obesity was more prevalent in women thirteen years ago, but male obesity has caught up and overcome the female prevalence). These findings are in agreement with other literature available Research: Chapter 1 100 from developed countries, which suggests that women hold a more negative attitude towards obesity than men and they are also more heavily influenced by the public negative view towards obesity, thus spending more time, effort and money on the ideal thinner shape (Manios et al. 2005). Regarding WC overweight and obesity prevalences, this study has shown that in ENCAT 2002-03, mean WC was higher in males and females as compared to ENCAT 1992-93 (except for the female group aged 45-64 years). In men, overall WC overweight increased (from 21.7% in 1992-93 to 23.8% in 2002-03), as well as overall WC obesity (from 13.1 to 24.4%). In women, overall WC overweight decreased (from 21.8 to 17.7%), while overall WC obesity increased (from 24.5 to 31.1%). In other words, our results on BMI and WC overweight and obesity suggest that Catalan men are getting bigger overall and also around specifically the waist, while Catalan women are getting smaller overall but with bigger waistlines. They also show that WC obesity is increasing more rapidly than BMI and, while BMI obesity is more prevalent among men, WC obesity is more prevalent among women. These findings agree with those of several recent studies carried out in Northern Europe (Sarlio-Lähteenkorva et al. 2006; Chen & Tunstall-Pedoe 2005). There are few studies that examine the possible relationship of SES and overweight and obesity prevalence, and even fewer for the actual distribution of its prevalence into the SES groups (Sarlio-Lähteenkorva et al. 2006; Manios et al. 2005; Choiniere et al. 2000). Although comparisons are not directly possible, there are three studies that show that obesity rates have been increasing for decades and are in line with our findings in that the prevalence of obesity is higher for the lower SES groups (two of these studies use education (Berkman & Breslow 1983; Lynch et al. 1997) and one uses income (Choiniere et al. 2000) and for men. Data from the ENCAT 2002-03 survey showed an increasing trend in the prevalence of BMI obesity in all male SEL (using occupation) groups as compared to ENCAT 1992-93, whereas female BMI obesity prevalence only increased in the high SEL group (although not significantly). The analysis showed that SEL had no influence on male BMI overweight or obesity prevalence, and that it only had an influence on BMI overweight and obesity prevalence among the oldest females (45-64 years and 65-75 year-olds), showing an inverse relationship (this further stratification by age group is not shown in the results). Referring to WC, in the ten-year period, only female WC overweight and obesity changed due to SEL, overweight decreased (being highest in the lowest SEL but no inverse relationship was observed) and obesity increased (highest in the lowest SEL, Research: Chapter 1 101 showing an inverse relationship). These findings are in agreement with numerous studies carried out in developed countries by which, overall, the prevalence of obesity is higher in lower SEL groups (Aranceta et al. 2001; Sarlio-Lähteenkorva et al. 2006; Stam-Moraga et al. 1999). In developing countries the problem has been shown to be more prevalent among the highest SEL groups, some showing the inverse relationship between overweight/obesity and household amenities in both genders and occupational level in men (Fezeu et al. 2006). Studies using the Spanish population have shown that the prevalence of obesity is higher among women and increases with age, particularly in the least educated female subgroups (Aranceta et al. 2001; Gutiérrez-Fisac et al. 1994), results that agree with the findings of the present study. The further stratification of each education level by age group (not shown in the results), revealed different prevalences from the overall male and female BMI obesity prevalences probably because the least educated people were mostly the older age group with a higher obesity prevalence, which agrees with findings from the SEEDO´97 Study (Aranceta et al. 2001). Regarding WC, we have shown that overweight basically increased in the male and female highest ELS groups, while obesity increased in all ELS groups, being highest in the lowest ELS one (inverse relationship) and most prevalent among the females of this group (reaching an alarming prevalence of 69.5%), and affecting more prominently the 45-64 year-olds (again probably because the least educated people were mostly the older age group with a higher WC obesity prevalence–analysis not shown). These results coincide with those obtained in recent studies (Molarius et al. 2000; Chen & Tunstall-Pedoe 2005; Gutiérrez-Fisac et al. 2004), in particular, a study carried out in Spain which showed an even higher prevalence of WC obesity in non-educated elderly females (80.9%) (Gutiérrez-Fisac et al. 2004). With regard to the influence of the area of residence (population size) on excess body weight, no significant differences were found for BMI prevalences in the 10-year period, in the 10-year period, significant differences were found for BMI overweight in both sexes and for female BMI obesity; the differences were also significant for WC male and female overweight and female WC obesity. Females living in the smallest communities showed a decrease in BMI and WC overweight..However, this decrease was probably at the expense of an increase in the female WC obesity. Studies carried out on the Spanish population (Aranceta et al. 1998; Aranceta et al. 2001) disagree with our BMI findings by not showing significant differences on overweight and obesity Research: Chapter 1 102 when stratifying by population size, but no comparable results are available for WC prevalences. Finally, SES has been found to be associated with dietary patterns and physical activity (Aranceta et al. 1998; Stam-Moraga et al. 1999; Manios et al. 2005; Proper et al. 2007). For example, more disadvantaged population groups generally have a poorerquality diet (e.g. higher fat intake and lower vegetable consumption) than higher SES groups, which may partly explain the inverse association between SES and obesity demonstrated in some studies (Manios et al. 2005; Proper et al. 2007). Other studies have evaluated how money expenditure on food can assist in the achievement of a healthy diet (Manios et al. 2005; Drenowski & Specter 2004). The inverse relationship between energy density and energy cost suggests that “obesity-promoting” foods are simply those that offer the most dietary energy at the lowest cost. The relative cost also has been taken into account, which increases even further the cost of the healthy diet for the low-income families (Manios et al. 2005). The present study has not considered diet, physical activity, income (at least not directly), expenditure on food or food costs in its analysis (which was merely descriptive and far from suggesting causality due to the cross-sectional nature of the data;, therefore, the authors recognize the need for a further and more robust analysis that involves all these lifestyle variables known to affect the relationship between prevalence of excess body weight and SES. In addition, self-reported occupation and education level may be over or under estimated. However, this probably has not significantly modified the classification of the participants into the three SES groups. Moreover, this study has not adjusted WC for BMI, which should be done due to the influence a high BMI can have on a high WC (Sarlio-Lähteenkorva et al. 2006). In spite of the mentioned limitations, we believe that our findings contribute to the evidence needed to guide public health policy makers in the design and implementation of preventive campaigns against the increasing trends of overweight and obesity, paying special attention to males and low SEL and education level groups, and small population of residence size (for male overweight and female obesity). 2.3.4.1 Updating note (not included in the Public Health Nutrition publication) Main results showed that SES variables had an influence on BMI and WC overweight and obesity rates mainly on females. WC obesity was only inversely related with SES in females (both ENCAT surveys) and the differences among SES groups were Research: Chapter 1 103 significant. Moreover, female WC obesity in the lowest education level group increased by 20 percentage points in 10 years. We concluded that Catalan males were getting bigger overall and around the waistline, while Catalan females (over 45 years) were getting thinner overall but with bigger waistlines -and more so in the lower SES level groups. Although these results are significantly important in terms of public health, the data were obtained one and two decades ago (1992-93 and 2002-03 respectively) and so I feel that the discussion included in their Public Health Nutrition publication (2006-07) needs updating and contrasting with more recent data. In this respect, it has to be said that unfortunately, recent studies such as the ENRICA study (Gutiérrez-Fisac et al. 2012) have shown that chapter 1’s findings still prevail almost a decade later, with significant differences between sexes in Spain overall (higher overweight rates in men and higher obesity rates in women); in Spanish women overall, with obesity decreasing as education level increases, in overall Spain; and with abdominal obesity being much higher in women as compared to men in Catalonia. Table 12 compares the prevalence rates of general and central obesity in the Catalan adult population of three crosssectional surveys: the ENCAT 1992, ENCAT 2003 and the ENRICA 2011 study. Disregarding the different methodologies used in ENCATs and ENRICA an the fact that rates are not directly comparable, we can observe an increasing trend for both general and central prevalence rates over the years. But most importantly, it can be observed that, while general obesity rates are increasing at a similar pace among men and women, central obesity rates among women are -in all three surveysconsistently higher than men’s rates, getting close to the 40% in the most recent study. Table 12. Comparison of general and abdominal obesity prevalence rates from 3 surveys conducted in the population of Catalonia.  ENCAT 1992 (%) ENCAT 2003 (%) ENRICA 2011 a (%) General obesity DĞŶ;BMI>30kg/m 2 Ϳ 9.9 16.6 21.8-24.8 tŽŵĞŶ;BMI>30kg/m 2 Ϳ 15.0 15.2 20.1-23.4 A bdominal obesity DĞŶ;tхϭϬϮĐŵͿ 13.1 24.4 25.5 tŽŵĞŶ;tхϴϴĐŵͿ 24.5 31.1 34.5-38.9 a. Source of data: Gutiérrez-Fisac et al. 2012. 2.2 - Chapter 2:  Trends in the association between smoking history and general/central obesity in Catalonia (1992-2003), Spain Research: Chapter 2 112 Variables included as confounders in the final multivariate models were: age, education level, occupation level, PA level at work, alcohol (ethanol) consumption, energy intake and fruit and vegetable consumption. Confounder selected included all variables that changed odds ratios (OR) of interest by >10% in at least some models. Within the analysis sample, sensitivity analyses were also carried out to assess whether missing values for covariates were influential, confirming that excluding subjects with missing values did not influence the main associations of interest (not shown). Final models excluded subjects with missing values for all covariates included. Results are presented as odds ratios and 95% confidence intervals (CIs). Mantel-Haenzel test for trend was used to determine whether there was a dose-dependent relationship between smoking history/intensity and BMI and between smoking history/intensity and WC (p<0.05 as significance level). All prevalence estimates and ORs were weighted using the Catalan census population of 1991 and 2001 (IDESCAT: Estructura de la població, 1975–2003) respectively, accounting for the population gender and age group distribution. 2.2.3 Results Prevalence and trends in general and central obesity Levels of overweight/obesity were substantial, and consistently higher in men than in women (55.3% vs. 44.4% in 1993 and 64.7% vs. 42.2% in 2003, p<0.05); levels of IR/SIR WC, also substantial, were initially higher in women than in men (35.9% in men vs. 48.6% in women p<0.05) but very similar in the second survey (men 50.9% vs. women 49.1%, p<0.05) (Table 13). Over time, there was a substantial increase in the prevalence of obesity (7%) as well as in SIR WC (11%) in men, though levels of overweight and IR WC were fairly stable. Among women, there was a substantial increase in the prevalence of SIR WC (7%), though overweight and obesity levels remained fairly stable and IR WC declined. Thus overall, among men, there were increases in overweight/obesity (55.3% and 64.7% in 1992-1993 and 2002-2003 respectively) and IR/SIR WC (35.9% and 50.9%), while among women levels of overweight/obesity (44.5% and 42.2%) and IR/SIR WC (48.6% and 49.1%) remained fairly stable, albeit with an increase in the prevalence of SIR WC (Table 13). Research: Chapter 2 113 Table 13. Prevalence of overweight a , obesity b , IR WC c and SIR WC d , by gender and survey. Men Women ENCAT 1992-93 (n=502) ENCAT 2002-03 (n=595) ENCAT 1992-93 (n=602) ENCAT 2002-03 (n=590) Overweight/obesity e 55.3% 64.7% 44.4% 42.2% Overweight 46.8% 49.2% 31.0% 28.4% Obesity 8.5% 15.5% 13.5% 13.8% IR/SIR WC f 35.9% 50.9% 48.6% 49.1% IR WC 24.0% 28.1% 24.8% 18.4% SIR WC 11.9% 22.8% 23.8% 30.7% a.Overweight= BMI 25-<30 kg/m 2 ; b. Obesity= BMI 30 kg/m 2 ; c.IR WC= Increased-risk of metabolic complications (i.e. WC >94 cm for men and WC >80 cm for women); d. SIR WC= Substantially-increasedrisk of metabolic complications (i.e. WC >102 cm for men and WC >88 cm for women); e. Overweight/obesity = overweight plus obese subjects; f. IR/SIRWC = subjects with IR WC plus subjects with SIR WC. Prevalence and characteristics of never, former and current smokers In 1992-1993, 53.6% of men and 30.8% of women reported being current smokers. Over time, as shown in Table 14, the prevalence of current smoking decreased substantially in men (by 13%), though only slightly in women (2%), while the percent of former smokers increased (by almost 4% in men and by 9% in women). The prevalence of heavy smoking (>20/day) declined from 10.9% to 8.2% in men, and from 3.2% to 2.1% in women (not shown). Table 14 also shows that, among males, both mean BMI and WC increased in all smoking history groups, with larger increases among never than former or current smokers (4.8 cm vs. 3.0 cm for WC). Among female never smokers, however, mean BMI and WC decreased over time, while both measures of obesity increased among former and current smokers. Moreover, among men in both surveys, current smokers had the highest percentages of low occupational social class, low levels of education, sedentary physical activity at work, low fruit and vegetable consumption and high ethanol consumption. However, among females, these percentages were highest in never smokers. Research: Chapter 2 114  Table 14. Male and female characteristics by survey and cigarette smoking history.* Cigarette smoking history Characteristics Never Former Current ENCAT 1992-93 2002-03 1992-93 2002-03 1992-93 2002-03 MEN 26.1% 35.9% 20.3% 23.9% 53.6 % 40.2% Age (years) 40.6 (0.98) 40.1 (0.75) 44.9 (1.08) 45.3 (0.84) 40.0 (0.69) 38.7 (0.66) BMI (kg/m 2 ) 25.6 (0.28) 26.6 (0.29) 26.5 (0.33) 26.9 (0.29) 25.2 (0.21) 26.1 (0.26) WC (cm) 89.5 (0.82) 94.3 (0.85) 92.5 (1.05) 95.5 (0.91) 89.8 (0.65) 92.8 (0.77) Percent low social class** 25.8% 35.4% 22.2% 25.3% 52.0% 39.4% Percent low education level‡ (< 6 years) 24.4% 29.5% 31.3% 24.8% 44.3% 45.7% Percent low HH education level¥ (< 6 years) 27.8% 35.8% 25.1% 21.1% 45.2% 43.2% Percent sedentary occupational physical activity 33.0% 37.8% 23.3% 25.5% 43.8% 36.7% Total energy intake (kcal/d) 2209.2 (38.8) 2173.2 (26.8) 2121.2 (48.7) 2112.2 (32.6) 2219.9 (33.9) 2139.5 (29.6) Percent low fruit & vegetable consumption (<170g/d) 21.8% 31.9% 11.2% 16.4% 67.1% 51.7% Percent high ethanol consumption (level 3) 29.9% 14.3% 5.0% 42.4% 65.1% 43.3% WOMEN 56.9% 49.5% 12.3% 21.3% 30.8% 28.8% Age (years) 45.1 (0.63) 42.8 (0.63) 36.5 (0.86) 41.4 (0.81) 35.2 (0.70) 38.0 (0.71) BMI (kg/m 2 ) 26.6 (0.31) 25.2 (0.25) 23.6 (0.42) 25.1 (0.43) 23.5 (0.27) 24.5 (0.35) WC (cm) 83.5 (0.78) 82.4 (0.71) 76.5 (1.19) 82.1 (1.12) 76.8 (0.70) 80.6 (1.01) Percent low social class** 68.1% 54.3% 6.3% 19.7% 25.6% 25.9% Percent low education level‡ (< 6 years) 76.5% 64.9% 6.9% 14.3% 16.6% 20.8% Percent low HH education level¥ (< 6 years) 65.8% 60.6% 5.1% 15.7% 29.1% 23.7% Percent sedentary occupational physical activity 48.4% 46.6% 13.9% 20.9% 37.7% 32.5% Total energy intake (kcal/d) 1606.7 (20.4) 1661.5 (19.2) 1627.8 (33.2) 1671.7 (30.0) 1684.9 (23.5) 1663.9 (25.9) Percent low fruit & vegetable consumption (<170g/d) 45.9% 40.5% 10.9% 16.0% 43.3% 43.5% Percent high ethanol consumption (level 3) 52.3% 47.1% 18.8% 9.4% 29.0% 43.5% * Values are proportions or means (SE) as shown. **Low occupational social class defined based on the household head's occupation being manual or unskilled workers, as well as farmers or fishermen. ‡Low education level defined as< 6 years of schooling for each individual. ¥Low household head (HH) education level defined as< 6 years of schooling. Research: Chapter 2 115 Shifts in the prevalence of general and central obesity by smoking history group Figures 21 and 22 show prevalence rates of general and central obesity by smoking history. In 1992-1993, among men, former smokers had the highest prevalence of overweight, obesity, and both IR and SIR WC. By 2002-2003, however, substantial increases among never and current smokers led to levels of general and central obesity similar to those in former smokers. More specifically, in 2002-2003, while former smokers had the highest prevalence of overweight (57.2%) and SIR WC (28.2%), never smokers had the highest rates of obesity (19.3%) and current smokers had the highest level of IR WC (30.7%). In contrast to men, among women, in 1992-1993 the prevalence of overweight, obesity, IR WC and SIR WC was highest among never smokers. As among men, however, in 2002-2003 disparities in prevalence rates across smoking groups were substantially diminished as a consequence of increased levels in both former and current smokers, as well as lower levels in never smokers. Research: Chapter 2 116 Figure 21. Prevalence of BMI categories in male (top) and female (bottom) never smokers, former smokers and current smokers, by Survey. ENCAT 1992-1993 and 2002-2003. 42.7 33.7 51.4 34.3 29.6 39.0 48.6 54.5 40.6 46.3 57.2 47.5 8.7 11.8 8.0 19.3 13.3 13.5 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Never Former Current Never Former Current ENCAT 1992-1993 ENCAT 2002-2003 Frequency BMI <25 BMI 25-<30 BMI >=30 43.4 72.7 70.0 55.6 56.4 62.9 35.7 22.2 25.5 28.0 32.3 26.0 21.8 5.1 4.5 16.5 11.3 11.1 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Never Former Current Never Former Current ENCAT 1992-1993 ENCAT 2002-2003 Frequency BMI <25 BMI 25-<30 BMI >=30 Research: Chapter 2 117 Figure 22. Prevalence of WC categories in male (top) and female (bottom) never smokers, former smokers and current smokers, by Survey. ENCAT 1992-1993 and 2002-2003. 71.6 50.5 65.6 48.0 43.8 53.4 19.6 32.0 22.4 25.9 27.9 30.7 8.8 17.5 12.0 26.1 28.2 15.9 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Never Former Current Never Former Current ENCAT 1992-1993 ENCAT 2002-2003 Frequency WC <94 cm (normal) WC 94-<102 cm (IR) WC >=102 cm (SIR) 39.4 70.3 66.0 47.5 50.3 57.2 30.7 15.8 17.6 19.3 21.0 15.2 29.9 9.0 16.4 33.2 28.7 27.6 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Never Former Current Never Former Current ENCAT 1992-1993 ENCAT 2002-2003 Frequency WC <80 cm (normal) WC 80-<88 cm (IR) WC >=88 cm (SIR) Research: Chapter 2 118 Associations between smoking history and general and central obesity: 1992-1993 Ageand multivariate-adjusted associations between smoking history and overweight/obesity and IR/SIR WC are presented in Table 15. In 1992-1993, the multivariate-adjusted analysis showed that male moderate and heavy smokers were 0.40 and 0.63 times less likely to be overweight/obese than never smokers, although the association was only significant (p<0.05) for moderate smokers. Neither former smoking nor current-light smoking was associated with general obesity among men. For central fatness, however, both male former and current-heavy smoking were associated with a more than two-fold increased odds of IR/SIR WC compared to never smoking (p<0.05). In contrast to the null association among men, women who were current-light smokers were significantly less likely to be overweight/obese than never smokers (OR 0.42, CI 0.22-0.81). For central fatness, both former and current-light smokers had lesser odds of an IR/SIR WC than never smokers, with associations significant at the 10 and 5% level respectively, again contrary to the positive association between central fatness and former smoking observed in men. Results of the Mantel-Haenszel test for trend (Table 15) show a significant trend (p=0.007) only in male BMI overweight/obesity-smoking OR; in females however, OR for both BMI overweight/obesity-smoking and IR/SIR WC-smoking show a significant trend (p=0.000 and p=0.006 respectively). Associations between smoking history and general and central obesity: 2002-2003 In 2002-2003, when the prevalence rates of general and central obesity were notably higher, particularly in men, a rather different situation emerged, with most associations strongly attenuated compared to those observed in 1992-1993. Thus among men, current moderate and heavy smoking were no longer associated with general overweight/obesity, and former smoking was no longer associated with IR/SIR WC. However, current heavy smoking remained associated with IR/SIR WC, although the magnitude of the association was nearly two-fold rather than three-fold. Associations were similarly attenuated towards the null among women in 2002-2003. Current light smoking was no longer associated with reduced odds of overweight/obesity or with reduced odds of IR/SIR WC, and former smoking was no Research: Chapter 2 119 longer associated with reduced odds of IR/SIR WC. However, current moderate smokers were 0.57 times less likely to have an IR/SIR WC as compared to never smokers, although the association was very weak (p<0.10). Results of the Mantel-Haenszel test (Table 15) show a significant trend in female BMI overweight/obesity-smoking OR and IR/SIR WC-smoking OR (P=0.046 and P=0.025 respectively), but not in any of the male OR. Research: Chapter 2 120 Table 15. 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The 1992-93 general overweight, obesity and excess central fatness prevalence rates were higher in male former smokers and female never smokers. Similar results showing lower BMI in current smokers have been reported by other studies (Lissner et al. 1992; Molarius et al. 1997; Martínez et al. 1999; Canoy et al. 2005; Akbartabartoori et al. 2005; Pisinger & Jorgensen 2007; Travier et al. 2009). However, findings by John et al. (2005) only agree with our female results, as they found lower overweight or obesity in female heavy smokers as compared to never smokers; nevertheless, our results from heavy smoking in women could not be properly analyzed because the sample size was too small. For males, they found higher proportions of overweight or obesity among moderate smokers as compared to never smokers. Between 1992-93 and 2002-03, current smoking prevalence, initially more than 50%, declined substantially in men, though it remained fairly stable among women (30.828.8%). Other authors that studied the period 1982-1998 also found decreasing smoking prevalence trends among Catalan men, but increasing trends among Catalan women and young adults of both sexes, concluding that tobacco smoking rates were stable (Jané et al 2001). Using data from 2005, the WHO reported similar percentages of tobacco use among Spanish adults, which ranged between 28.6-36.5% (WHO 2008). In addition, levels of overweight, obesity and IR/SIR WC were substantial in 1992-93, but there were nonetheless substantial increases over time, particularly in obesity and SIR WC. According to the ENRICA study (Banegas et al. 2010), in Catalonia, by 2010, male general obesity prevalence had reached a 23.7% (an 8-point increase if compared to ENCAT 2003) and that of female a 21.2% (a 7-point increase when compared to ENCAT 2003). The increases in obesity and SIR WC observed in ENCAT were highest among male never smokers, but were also substantial among current female smokers, with smaller increases in former smokers. Moreover, associations between current smoking intensity and general obesity, adjusted for confounders such as subject's age, energy intake, physical activity at Research: Chapter 3 129 2.3.1 Introduction Botanicals and their derivatives/preparations are used throughout Europe for health purposes, with increased usage in the general population as well as among specific subgroups encompassing children and pregnant women or those suffering from diseases such as cancer among others (Menniti-Ippolito et al. 2002; Ritchie 2007; Adams et al. 2009; Bishop & Lewith 2010). Botanicals are used in many different types of products, including foods, (teas and juices), food supplements such as plant food supplements (PFS), herbal medicinal products (HMP), homeopathic products, cosmetics, biocides etc (Larrañaga-Guetaria 2012). These different product categories are regulated by specific legislation, depending on the intended use of the product. The European Union (EU) Directive on Food Supplements (2002/46/EC) defines dietary supplements (which include PFS) as (European Parliament & Council 2002): “…foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles and other similar forms of liquids and powders designed to be taken in measured small quantities”. The marketing of a product as a PFS however, depends on national legislation, which differs widely across Member States. Countries vary in the extent to which products are regulated, as well as in the process of regulatory control. Some countries have regulated the use of botanicals in detail (including negative and positive lists), some apply specific conditions of use, (including maximum usage levels or warnings for the consumer), and in others less specific requirements exist. An added complexity lies in the application of the basic European “principle of mutual recognition”, whereby any product that is lawfully marketed in one Member State can be sold in all 27 Member States (Larrañaga-Guetaria 2012). Moreover, the same botanical may be used as a food supplement and as a medicinal product, depending on the intended use of the product and both food supplements and medicinal products often share the same form of presentation (powders, pills or tablets). Hence the legal status of products differs from one country to another, resulting in a complex market environment. This so-called borderline issue between PFS and HMP is a major obstacle to the marketing of PFS in the EU (Larrañaga- Research: Chapter 3 130 Guetaria 2012). Plant food supplement usage data at EU level are scarce with reports providing PFS market data as opposed to data reported directly by the consumer (EAS 2007). Surveys on the intake of botanicals have been conducted primarily in the context of the intake of dietary supplements in general (Skeie et al. 2009) or as part of surveys of complementary and alternative medicine (CAM) therapies (Vargas-Murga et al. 2011), and issues such as the legal distinction between HMP and PFS have not been taken into account. A recent systematic review evaluating the demographic characteristics and health status factors associated with CAM use reported that the majority of population based consumption studies had been conducted in the USA (64% of the 110 identified studies), and of these, 13% were in Europe, with the majority carried out in Scandinavia (7%) and the United Kingdom (5%) (Bishop & Lewith 2010). Studies have been limited by the heterogeneity of definitions used, study designs and objectives making it difficult to compare results and to extrapolate conclusions. The ambiguity of categories such as ‘‘natural medicine’’, ‘‘herbal remedies’’ or ‘‘herbal medicine’’ and what constitutes ‘‘dietary supplements’’ makes it nearly impossible to attain reliable estimates of the prevalence of PFS usage in Europe, with only limited data available at national levels (Vargas-Murga et al. 2011; Harrison et al. 2004; INFITO 2007) But not at the European level. A study by the European Advisory Services (EAS) on “The use of substances with nutritional or physiological effect other than vitamins and minerals in food supplements” (EAS 2007), provided information on European market and regulation data, and highlighted the need for obtaining PFS usage data in order to plan, monitor and evaluate national and European policies, as in other regions of the world. One such example is the United States of America, where the Alternative Health/CAM supplement of the National Health Interview Survey (NHIS) has been collecting data on botanical dietary supplements for some years now (NCHS 2003; Bardia et al. 2007; Dwyer et al. 2013). The EFSA has recognised the lack of data in the sector and has published a number of reports addressing related issues, namely the recommendations for reporting the use of supplements and medicines by adults in any pan-European dietary survey or project (EFSA 2009), and the “Compendium of botanicals reported to contain naturally occurring substances of possible concern for human health”, aimed to help with the safety assessment of botanicals and botanical preparations intended for use as food Research: Chapter 3 131 supplements (EFSA 2012). The purpose of this paper is to describe the type and frequency of PFS usage reported in a retrospective survey of consumers in six European countries; in addition we present the most frequently used botanical ingredients in these products. We also highlight the issues associated with measuring usage of PFS in European populations and make recommendations for future research. 2.3.2 Materials and methods Ethics statement Before initiating the fieldwork, approval for the conduct of the survey was obtained from four ethics committees: the Bioethics Commission of the University of Barcelona, Spain; the Ethics Committee of the University of Milano, Italy; the Ethical Committee of the Faculty of Medicine - Transilvania University of Brasov, Romania; and the Coordinating Ethics Committee, Hospital District of Helsinki and Uusimaa, Finland. Approval of the survey by these four ethics committees required submitting all survey material to their members for evaluation. No ethical approval for the survey was needed in Germany and the United Kingdom. To ensure harmonisation and standardisation of the fieldwork and data collection across countries, a market research organization, European Fieldwork Group (EFG) was subcontracted to implement the survey. The survey was conducted by EFG in strict accordance with the ICC/ESOMAR Code on Market and Social Research. In all countries, informed consent was obtained verbally from all respondents after reading the survey information sheet. All data were recorded manually i.e. pen-and-paper. Recruitment of survey participants occurred in the selected cities in each country. Approximately the first 1000 individuals per country were systematically selected for screening i.e. intercepting 1 in every 5 individuals passing by to ask him/her the initial screening questions; subsequent screening selection was performed on a convenience basis i.e. intercepting individuals in places where consumers were likely to be found, such as herbal shops, pharmacies etc. Eligible respondents who agreed to participate were given an appointment at their home/workplace to complete the main survey. The appointments of those willing to participate were later reconfirmed by phone. Research: Chapter 3 132 The data were made anonymous when recorded electronically i.e. the respondents’ contact details were not entered into the survey database. Instead, the market research organization assigned ID numbers to each respondent and provided PlantLIBRA partners only the database with the assigned ID numbers. Definition of plant food supplements in the PlantLIBRA PFS consumer survey Although there is a legal definition of Food Supplements (EU Directive (2002/46/EC) (European Parliament & Council 2002) under which PFS reside, for the purposes of this research it was necessary to develop a specific definition of PFS whose main characteristic is that they contain botanical preparations as ingredients for food supplementation. Botanical preparations are obtained by subjecting botanicals (plants, algae, fungi or lichens) to treatments such as comminution, extraction, distillation, squeezing, fractionation, purification, concentration or fermentation. These include extracts, essential oils, expressed juices, powders, etc. Botanical preparations can be considered as nutrients or other substances. Thus, the definition of PFS for the survey was as follows: PFS are "foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of botanical preparations that have nutritional or physiological effect, alone or in combination with vitamins, minerals and other substances which are not plant-based. PFS are marketed in dose form, such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities”. Products that did not meet this definition, such as herbal remedies and other medicinal products based on botanicals, and those that did not meet the PFS definition in terms of dosage, such as herbal teas or juices, were excluded. Sample population and PFS consumer definition A cross-sectional, 12-month retrospective survey was conducted in 24 cities in six European countries -Finland, Germany, Italy, Romania, Spain and the United Kingdom. An estimated sample size of 2000 screened individuals per country was calculated in Research: Chapter 3 133 order to obtain a final sample of approximately 400 consumers per country (total N=2400 approximately). Per country, gender and age group quotas were set as follows: 300 adults (18 to 59 years) and 100 older adults (60-and-over years), with 3050% male and 50-70% female. All individuals were screened by means of a brief questionnaire which recorded PFS usage in the preceding 12 months. Individuals were considered eligible for inclusion if they were over 18 years old and met either of the following specified criteria, intended to capture the different usage patterns of PFS consumers: 1) They had taken at least 1 PFS in the last 12 months, in an appropriate dose form at a minimum frequency of either: a) 1 daily dose for at least 2 consecutive or non-consecutive weeks, or b) 1 or more doses per week for at least 3 consecutive weeks or c) 1 or more doses per week for at least 4 consecutive or nonconsecutive weeks 2) They had taken 2 or more different PFS, in an appropriate dose form, at a minimum frequency of 1 or more doses per week, with the sum of the usage period of the 2 or more products being equal to at least 4 weeks.  Instruments and variables A short screening questionnaire was used to identify consumers who met the survey inclusion criteria; it consisted of six questions which allowed interviewers to identify eligible consumers, based on the product(s) used, the frequency and duration of use and the dose form. Eligible consumers subsequently completed a more detailed questionnaire on their PFS usage in the preceding 12 months, providing details of product/plant names, dosage forms, frequency of use, reasons for use, adverse effects, places and patterns of purchase and information sources on products. These questions were asked for each of up to a maximum of 5 different PFS used. In addition, respondents were asked to provide socio-demographic data including age, gender, level of education and employment status, as well as self-reported height and weight and further health-related lifestyle information. Survey administration and data collection Fieldwork and data collection for the cross-sectional survey were performed by the international market research company EFG, from May 2011 to September 2012. The duration of the fieldwork ensured that any seasonal variability in usage of products was Research: Chapter 3 134 captured. The survey protocols and instruments -training material, information sheet, informed consent, screening and usage questionnaires-, were initially developed in English by consensus amongst the research team, and subsequently translated into the respective languages in each of the survey countries. Pilot interviews were conducted in each participating country to assess the comprehension of the questions and to determine the time required to complete the survey. In each participating country, trained interviewers systematically screened approximately 1000 individuals during the first three months of the survey, which allowed the estimation of the prevalence rate. Subsequently, screening and recruitment were conducted on a convenience basis. The recruited eligible consumers were interviewed face-to-face and the more detailed PFS usage questionnaire completed. Data preparation and statistical analysis All data from the completed surveys were entered into the statistical package SPSS for Windows v. 18 (IBM Corporation, Somers, NY, USA), which was also used for data analysis. Following review of the completed interviews by the research team in each country, a database with botanical composition data for all PFS products reported was compiled for each country and then merged into a single database. Potential product duplicates between countries were not removed. Each product was coded for its botanical ingredients in scientific, English and local names and botanicals were coded after removing duplicates between countries. Additionally, each product was categorised as a singleor multi-botanical product. To indicate the certainty of the matching of products, a series of numerical codes were used, based on those used in the National Health and Nutrition Examination Survey 2005 – 2006 (NCHS 2009). Values ranged from 1-5, where “1” indicated an exact match, “2” a probable match, “3” a reasonable match, “4” a default match and “5” no match. Only products with certainty values 1 to 4 have been included in the analyses. Respondent data were recorded in a separate database. A number of variables were created and/or recoded to facilitate reporting and analysis, including: 1) “education level”, defined as low, medium, and high; 2) “BMI”, which was calculated from selfreported weight and height, and for which WHO criteria (WHO 2013) were used to categorise individuals as underweight (BMI<18.5 kg/m 2 ), normal weight (BMI 18.5-<25 Research: Chapter 3 135 kg/m 2 ), overweight (BMI 25-<30 kg/m 2) and obese (BMI >30 kg/m 2 ); 3) “physical activity”, calculated using the short version of the IPAQ questionnaire (Craig et al. 2003) and defined as low, moderate or high. Absolute frequencies and percentages for each of the variable categories were used to describe the qualitative nominal/ordinal and discrete quantitative survey data. In turn, all data have been stratified by gender, age range and country - also using absolute frequencies and percentages and 95% confidence intervals. When describing the association between two qualitative variables (nominal or ordinal), contingency tables were used. The continuous quantitative variables (e.g. BMI, alcohol) were recoded into categorical variables. It is important to note that when reporting the main results of the survey, the unit of analysis varies depending on the variables used, i.e. for certain variables the unit is an individual respondent, however, given the potential intake of multiple supplements by one respondent, the unit of analysis may change to the supplement level. Furthermore, all results presented in the tables represent the analysis of raw data as opposed to data weighted by the population size. Data were not weighted because of the study methodology selected, whereby all country samples were very similar in size and included only PFS consumers. Validation study In order to validate the PFS usage questionnaire, a validation study was conducted in which the data collected using the survey instrument (questionnaire) were compared with data collected with a 30 to 180-day diary (used as the gold standard). The study was conducted in two of the PlantLIBRA consumer survey cities: Las Palmas de Gran Canaria (Spain) and Milan (Italy), where 48 and 49 consumers respectively were recruited using convenience sampling. The PFS usage questionnaire was completed by the respondents at the beginning and at the end of the 6-month period of the validation; during this time the consumers also completed the usage diary. Data from the last questionnaire and the diary were compared for concordance, and results are shown in Table 16, indicating a good agreement for product consumed, dose form and doses per day. Research: Chapter 3 136 Table 16. Validation study results. V ariable Concordance a Milan Las Palmas de Gran Canaria n % n % Product used Yes 47 95.9 48 100.0 No 2 4.1 0 0.0 Dose form (pills, capsules, etc) Yes 45 91.8 47 97.9 No 4 8.2 1 2.1 Doses per day Yes 45 91.8 38 79.2 No 4 8.2 10 20.8 a ConcoUGDQFHEHWZHHQERWKPHWKRGVWKH3)6XVDJHTXHVWLRQQDLUHDQGWKHPRQWKXVDJHGLDU\ 2.3.3 Results Characteristics of the PFS consumer sample A final sample of 2359 consumers (those eligible and willing to participate) was recruited from 11783 screened individuals (Table 17). Due to different legal frameworks (different distribution of botanicals in food supplements and medicinal products), more individuals had to be screened in Finland in order to recruit the required 400 consumers. Table 17 also shows the sample used for the estimation of the usage prevalence rate. The estimated weighted overall PFS usage prevalence rate was 18.8% and per-country rates were as follows: Finland 9.6%, Germany 16.9%, Italy 22.7%, Romania 17.6%, Spain 18.0% and the United Kingdom 19.1%. Survey respondents were recruited to fixed quotas for age and gender, which were achieved, with some differences within countries (Table 18). In Finland the proportion of adults aged 50-59 years was significantly higher (26.2%), whilst the opposite was true in Italy, where consumers in that age group constituted only 13.0% of adults. Romania had a significantly higher number of consumers in the youngest age group (30.5%), in contrast to Spain and the United Kingdom, where this age group represented only 9.5% and 9.0% of adult consumers, respectively. A significantly higher proportion of female consumers were recruited in Spain (56.7%) and in the United Kingdom marginally more males were recruited (50.3%). Across all countries, more than half of the participants (57.5%) were employed (Table 18), with the percentages slightly lower in Finland (50.9%) and in the United Kingdom (52.4%). The majority of participating consumers were educated to medium level (Table 18). Respondents were asked a number of questions regarding health-related lifestyle factors (Table 19). Less than half of the consumers had never smoked (46.6%), less Research: Chapter 3 137 than one quarter were ex-smokers (23.1%) and less than one third were current smokers (30.3%). More than half of the total respondents (59.3%) had not consumed alcohol or had consumed it less than once daily; more than a tenth (12.6%) reported daily alcohol consumption. The proportion of overweight and obese people in the survey was 49.8% (Table 19). Some significant differences in levels of physical activity were noted between countries. High levels of activity were reported by 85.5% of Romanian respondents compared to a value of 42.9% across all countries. Most of the respondents (65.1%) reported not being regular consumers of food supplements other than PFS in the preceding 12 months, except for Finland (Table 19). The proportion of non-consumers varied from 20.7% in Finland to more than 80% in the United Kingdom and Italy. By contrast, in Finland 76.3 % of the individuals were regular consumers of food supplements. Over half of all respondents (59.5%) reported not having used CAM therapies/treatments in the past year. This is particularly the case in Italy (74.6%), Romania (80.8%) and the United Kingdom (92.6%). Three quarters of consumers reported their health status as very good or good (75.5%), while 3.6% reported it as bad or very bad and 21.0 % as neither bad nor good (Table 19). Between countries, more consumers reported their health status as very good or good in Romania (81.3%) and in the United Kingdom (81.1%) than in other countries; though conversely the highest proportion reporting their health status as bad or very bad was also in the United Kingdom (7.6%). Research: Chapter 3 144 Table 22. PlantLIBRA's PFS consumer survey – Characteristics of PFS reported by respondents. 7RWDO )LQODQG *HUPDQ\ ,WDO\ 5RPDQLD 6SDLQ 8QLWHG.LQJGRP 1XPEHURISURGXFWV        1XPEHURIERWDQLFDOV        1XPEHURIPDQXIDFWXUHUV        0D[LPXPQXPEHURILQJUHGLHQWVSHUSURGXFW        Table 23. 3ODQW/,%5$V3)6FRQVXPHUVXUYH\±Qumber and type of products taken, overall distribution and by gender and age group.   7RWDO *HQGH U $JHJURXS Q  0DOHQ  )HPDOHQ  \HDUVQ  \HDUVQ   Q&,Q&,Q&,Q&,Q&, 1XPEHURISURGXFWVWDNHQ SURGXFW           SURGXFWV           !SURGXFWV           3URGXFWW\SH VLQJOHERWDQLFDO           PXOWLERWDQLFDO           RUPRUHVLQJOHERWDQLFDO           RUPRUHVLQJOHDQGPXOWLERWDQLFDO           Table 24. PlantLIBRA's PFS consumer survey – number and type of products taken, by country.   )LQODQGQ  *HUPDQ\Q  ,WDO\Q  5RPDQLDQ  6SDLQQ  8QLWHG.LQJGRPQ  Q &, Q &, Q &, Q &, Q &, Q &, 1XPEHURISURGXFWVWDNHQ SURGXFW             SURGXFWV             !SURGXFWV             3URGXFWW\SH VLQJOHERWDQLFDO             PXOWLERWDQLFDO             RUPRUHVLQJOHERWDQLFDO             RUPRUHVLQJOHDQGPXOWLERWDQLFDO             Research: Chapter 3 145 Table 25. PlantLIBRA's PFS consumer survey – PFS dose forms used, per product used by a respondent, overall and by gender and age group. 'RVHIRUPV7RWDO *HQGHU $JHJURXS Q  0DOHQ  )HPDOHQ  \HDUVQ  \HDUVQ   Q &, Q &, Q &, Q &, Q &, &DSVXOHV D           3LOOVWDEOHWVOR]HQJHV           /LTXLG E           $PSRXOHV           2WKHU F            4XHVWLRQDVNHG$QGLQZKLFKIRUPGR\RXXVXDOO\WDNHLW"PDUNWKHDSSOLFDEOHIRUP3RVVLEOHUHVSRQVHV3LOOVWDEOHWVOR]HQJHV6RIWJHOFDSVXOHVSHDUOV+DUGFDSVXOHV/LTXLG H[WUDFWV\UXSGURSV6DFKHWVSDFNHWV$PSRXOHV2WKHUVSHFLI\1RWVXUH D &DSVXOHVVRIWJHOVSHDUOVKDUGFDSVXOHV E /LTXLGH[WUDFWV\UXSVGURSV F 2WKHU3RZGHUV6DFKHWV3DFNHWV%DUVDQG³1RWVXUH´ Table 26. PlantLIBRA's PFS consumer survey – PFS dose forms, per product used by a respondent, by country. 'RVHIRUPV )LQODQGQ  *HUPDQ\Q  ,WDO\Q  5RPDQLDQ  6SDLQQ  8QLWHG.LQJGRPQ   Q &, Q &, Q &, Q &, Q &, Q &, &DSVXOHV D             3LOOVWDEOHWVOR]HQJHV             /LTXLG E             $PSRXOHV             2WKHU F              4XHVWLRQDVNHG$QGLQZKLFKIRUPGR\RXXVXDOO\WDNHLW"PDUNWKHDSSOLFDEOHIRUP3RVVLEOHUHVSRQVHV3LOOVWDEOHWVOR]HQJHV6RIWJHOFDSVXOHVSHDUOV+DUGFDSVXOHV/LTXLG H[WUDFWV\UXSGURSV6DFKHWVSDFNHWV$PSRXOHV2WKHUVSHFLI\1RWVXUH D &DSVXOHVVRIWJHOVSHDUOVKDUGFDSVXOHV E /LTXLGH[WUDFWV\UXSVGURSV F 2WKHU3RZGHUV6DFKHWV3DFNHWV%DUVDQG³1RWVXUH´ Research: Chapter 3 146 Botanicals used A total of 491 botanicals -used in at least one PFSwere reported across the six participating countries. An overview of all the reported botanicals -clustered by intervals of frequency of intake (number of consumers ranging from 194 to 5)- is shown in Table 27. Based on the survey results, the eleven most frequently used botanicals (numbers of consumers ranging from 194 to 100) in descending order are Ginkgo biloba (ginkgo), Oenothera biennis (evening primrose), Cynara scolymus (artichoke), Panax ginseng (ginseng), Aloe vera (aloe), Foeniculum vulgare (fennel), Valeriana officinalis (valerian), Glycine max (soybean), Melissa officinalis (lemon balm), Echinacea purpurea (echinacea) and Vaccinium myrtillus (blueberry) (Table 27). Table 28 shows the overall unweighted ranking of botanicals, 1-40, according to the number of consumers, in decreasing order. Table 28 also shows that when unweighted overall data are stratified by gender, only slight differences between men and women become evident and only Glycine max (soybean) was used significantly more by women than by men (Table 28). When the overall top-40 botanical data are stratified by age groups, slight differences become evident. In the group of 18-59 year-olds, the most frequently used botanicals comply with the overall data just differing in the ranking, with Oenothera biennis (evening primrose) being the most frequently used botanical (Table 28). In the group of 60+ year-old a stronger shift can be observed (Table 28). Although Ginkgo biloba (ginkgo) is still the most reported botanical -as in the overall rankingother botanicals are frequently used by that age group. Harpagophytum procumbens (devil´s claw), Vaccinium myrtillus (blueberry) and Allium sativum (garlic) are within the most frequently reported botanicals, whereas Glycine max (soybean), Melissa officinalis (lemon balm) and Echinacea purpurea (echinacea) do not appear in the top 10 ranking. Cross-country differences emerge when considering the overall top-40 botanicals more frequently present in PFS products in each of the individual six countries (Table 29). In the Finnish sample, products containing Glycine max (soybean) are the most frequently used, followed by those containing Echinacea angustifolia and purpurea (echinacea). German consumers reported Ginkgo biloba (ginkgo), Cynara scolymus (artichoke) and Olea europea (olive) as the most frequently used botanicals; whilst in Romania, Ginkgo biloba (ginkgo) was also the ingredient most frequently indicated, followed by Aloe vera (aloe) and Panax ginseng (ginseng). Amongst Italian consumers, Aloe vera (aloe) was Research: Chapter 3 147 the most frequently used botanical, followed by Foeniculum vulgare (fennel) and Valeriana officinalis (valerian). In Spain, PFS containing Cynara scolymus (artichoke) were the most frequently used products, followed by those containing Valeriana officinalis (valerian) and Equisetum arvense (horsetail). In the United Kingdom, Oenothera biennis (evening primrose) was by far the most frequently reported botanical ingredient, followed by Panax ginseng (ginseng) and Hypericum perforatum (St. John´s wort). In addition, there is a great variation in the ranking of consumed botanicals among countries. Research: Chapter 3 148 Table 27. 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)XFXVYHVLFXORVX V  3ODQWDJRRYDWH6RODQXPO\FRSHUVLFXP6SLUXOLQD SODWHQVLV6DFFKDURP\FHVFHUHYLVLDH  $ HVFXOXVKLSSRFDVWDQXP $ ORHIHUR [ %HUEHULVDULVWDWD%UDVVLFDROHUDFHDYDUERWU\WL V &DSSDULV VSLQRVD&DSVLFXPDQQXXPYDUDQQXXP+LHUDFLXPSLORVHOOD2SXQWLDILFXVLQGLFD6HUHQRD UHSHQV6RODQXPQLJUXP7ULEXOXVWHUUHVWULV0HOLVVDVSHF 9LWLVYLQLIHUD &DUXPFDUYL &LWUXVDXUDQWLXP  $ OOLXPFHSD $ SLXPJUDYHROHQ V %RVZHOOLDVHUUDWH&RIIHDVSHF(XWHUSHROHUDFHD)XPDULD RIILFLQDOLV*ULIIRQLDVLPSOLFLIROLD,OOLFLXPYHUXP0DOYDV\OYHVWULV3UXQXVDUPHQLDFD5DSKDQXV VDWLYXVFRQYDU6DWLYXV6ROLGDJRYLUJDXUHD7DPDULQGXVLQGLFD&DURWHQH*DUFLQLDFDPERJLD 6R\OHFLWKLQ  7DUD[DFXPRIILFLQDOH  5LEHVQLJUXP 6FKLVDQGUDFKLQHQVLV)ODYRQRLGV6\]\JLXP DURPDWLFXP  $ FRUXVFDODPX V  $ QJHOLFDVLQHQVL V  $ VFRSK\OOXPQRGRVXP(O\PXVUHSHQ V )LFXVFDULFD +DPDPHOLVYLUJLQLDQD3KDVHROXVYXOJDULV3UXQXVSHUVLFD5KHXPVSHF/XWHLQ&DSVLFXP DQQXXP)UD[LQXVVSHF&KDPRPLOH(QJ9LROHWDWULFRORU  (FKLQDFHDDQJXVWLIROLD  2U\]DVDWLYD $ QJHOLFDDUFKDQJHOLFD%HWDYXOJDULVVVSYXOJDULV YDUFRQGLWLYD&LWUXVVLQHQVLV-XQLSHUXV FRPPXQLV3HXPXVEROGXV  %UDVVLFDQLJUD%UDVVLFDROHUDFHDFRQYDUDFHSKDOD&DSVLFXPIUXWHVFHQV&DUWKDPXVWLQFWRULXV &RUG\FHSVVLQHQVLV'LRVFRUHDVSHF'URVHUDURWXQGLIROLD(FKLQDFHDSDOOLGD(PEOLFDRIILFLQDOLV )DOORSLDMDSRQLFD+HGHUDVSHF1LJHOODVDWLYD3ODQWDJRSV\OOLXP6DWXUHMDKRUWHQVLV7LOLD SODW\SK\OORV+LELVFXVURVDVLQHQVLV&LUVLXPVSHF)UDJDULDVSHF9LRODWULFRORU/DYDQGXODVSHF )UXFWRROLJRVDFFKDULGHV  $ OOLXPVDWLYXP3DVVLIORUDLQFDUQDWD  +LSSRSKDHUKDPQRLGH V  %RUDJRRIILFLQDOLV*HQWLDQDOXWHD+HOLDQWKXV DQQXXV2FLPXPEDVLOLFXP3DQLFXPPLOLDFHXP 3LQXVVSHF  $ ORHVSHF $ OSLQLDJDODQJD&KDPDHPHOXPQRELOH&RIIHDDUDELFD&RODDFXPLQDWD&\DPRSVLV WHWUDJRQRORED(TXLVHWXPWHOPDWHLD)DJRS\UXPHVFXOHQWXP+LELVFXVVDEGDULIID3LQXVSLQDVWHU 3LQXVV\OYHVWULV7K\PXVVSHF8QGDULDSLQQDWLILGD:LWKDQLDVRPQLIHUD,VRIODYRQHV$UHFDFHDH VSHF)DOORSLDPXOWLIORUD  /LQXPXVLWDWLVVLPXP  7ULWLFXPVSHF 3ODQWDJRODQFHRODWD5KDPQXVIUDQJXOD9DFFLQLXP YLWLVLGDHD   (TXLVHWXPDUYHQVH  5RVDFDQLQD&LQQDPRPXPVSHF &DULFDSDSD\D&LQQDPRPXPYHUXP&UDWDHJXV VSHF+RUGHXPYXOJDUH3RO\JRQXPDYLFXODUH 6DFFKDUXPRIILFLQDUXP6SLQDFLDROHUDFHD   +DUSDJRSK\WXPSURFXPEHQ V 2OHD HXURSDHD  6DPEXFXVQLJUD $ OJDH$YHQDVDWLYD%HWXODVSHF)LLOLSHQGXOD XOPDULD+XPXOXVOXSXOXV  Research: Chapter 3 149 Table 28. PlantLIBRA's PFS consumer survey – distribution of the overall top-40 botanicals’ reported consumption and the ranking of these botanicals when stratified by gender and age group. $OOFRQVXPHUV *HQGH U $JHJURXS %RWDQLFDOV  0DOH )HPDOH \HDUV \HDUV  5DQN D Q &, 5DQN E Q &, 5DQN E Q &, 5DQN E Q &, 5DQN E Q &, *LQNJRELORED                2HQRWKHUDELHQQL V                &\QDUDVFRO\PX V                3DQD[JLQVHQJ                $ ORHYHUD                )RHQLFXOXPYXOJDUHVVS                9DOHULDQDRIILFLQDOL V                *O\FLQHPD [                0HOLVVDRIILFLQDOL V                (FKLQDFHDSXUSXUHD                9DFFLQLXPP\UWLOOX V                3LPSLQHOODDQLVXP                =LQJLEHURIILFLQDOH                &DPHOOLDVLQHQVL V                9LWLVYLQLIHUD                7DUD[DFXPRIILFLQDOH                (FKLQDFHDDQJXVWLIROLD                3DVVLIORUDLQFDUQDWD                /LQXPXVLWDWLVVLPXP                (TXLVHWXPDUYHQVH                $ OOLXPVDWLYXP                +DUSDJRSK\WXPSURFXPEHQ V                2OHDHXURSDHD                *O\F\UUKL]DJODEUD                0HQWKDSLSHULWD                3DXOOLQLDFXSDQD                0DOSLJKLDJODEUD                2HQRWKHUDVSH F                6LO\EXPPDULDQXP                0DWULFDULDFKDPRPLOOD                &LWUXVOLPRQ                8UWLFDGLRLFD                7K\PXVYXOJDUL V                6DOYLDRIILFLQDOL V                &DVVLDVHQQD                5RVPDULQXVRIILFLQDOL V                &DUXPFDUYL                +\SHULFXPSHUIRUDWXP                /DYDQGXODDQJXVWLIROLD                5LEHVQLJUXP                D 3URGXFWVRUGHUHGDFFRUGLQJWRWKHFRQVXPHUGLVWULEXWLRQRIWKHRYHUDOOWRSXVHGERWDQLFDOVXQZHLJKWHGUDQNLQJ  E 5DQNVVKRZWKHVKLIWVRIWKHERWDQLFDOVLQWKHSRVLWLRQRIWKHRYHUDOOXQZHLJKWHGUDQNLQJZKHQVWUDWLILHGE\JHQGHUDQGDJHJURXS Research: Chapter 3 150 Table 29. PlantLIBRA's PFS consumer survey – ranking of the overall top-40 botanicals’ reported consumption when stratified by country. %RWDQLFDOV )LQODQG *HUPDQ\ ,WDO\ 5RPDQLD 6SDLQ 8QLWHG.LQJGRP  5DQN D Q &, 5DQN D Q &, 5DQN D Q &, 5DQN D Q &, 5DQN  Q &, 5DQN D Q &, *LQNJRELORED                   2HQRWKHUDELHQQL V                  &\QDUDVFRO\PX V                   3DQD[JLQVHQJ                   $ ORHYHUD                   )RHQLFXOXPYXOJDUHVVS                   9DOHULDQDRIILFLQDOL V                   *O\FLQHPD [                 0HOLVVDRIILFLQDOL V                   (FKLQDFHDSXUSXUHD                  9DFFLQLXPP\UWLOOX V                   3LPSLQHOODDQLVXP                  =LQJLEHURIILFLQDOH                   &DPHOOLDVLQHQVL V                  9LWLVYLQLIHUD                   7DUD[DFXPRIILFLQDOH                  (FKLQDFHDDQJXVWLIROLD                   3DVVLIORUDLQFDUQDWD                  /LQXPXVLWDWLVVLPXP                   (TXLVHWXPDUYHQVH                  $ OOLXPVDWLYXP                   +DUSDJRSK\WXPSURFXPEHQ V                   2OHDHXURSDHD                   *O\F\UUKL]DJODEUD                  0HQWKDSLSHULWD                   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           D 5DQNVVKRZWKHVKLIWVRIWKHERWDQLFDOVLQWKHSRVLWLRQRIWKHRYHUDOOXQZHLJKWHGUDQNLQJZKHQVWUDWLILHGE\FRXQWU\  Research: Chapter 3 151 2.3.4 Discussion The present paper reports the findings from a European multi-country survey of PFS consumers: the PlantLIBRA PFS consumer survey. Data on the usage of PFS at the European level are limited, confined in the main to commercial market data (EAS 2007) as opposed to consumer survey data, as evidenced in the recent review by Bishop and Lewith (2010), where only 13% of population based consumption studies were in Europe. The EFSA has recognised the lack of data in the sector and has published a number of reports addressing related issues (EFSA 2009; EFSA 2012). To our knowledge this is the first survey of consumers of PFS undertaken in Europe. In total 2359 consumers of PFS were recruited in this cross-sectional retrospective survey. Across all countries prevalence of usage is estimated at 18.8%. Vargas-Murga and colleagues (2011) highlighted that comparable data at European level is difficult to identify when reviewing prevalence data from a selected number of European studies, evaluating PFS or CAM usage, with values ranging from 0.8% to 70%. All studies were based on nationally representative samples but the definition of use of supplements varied widely, in some cases being self-defined by the participant and not distinguishing between PFS and HMP. The use of dietary supplements in a European population was measured in the European Prospective Investigation into Cancer and Nutrition (EPIC) study (Skeie et al. 2009). Usage was measured by completion of a standardised 24-hour dietary recall and included all dietary supplements that met the EU Directive 2002/46/EC. Results indicated significant differences in overall dietary supplement use between countries with herbs/plant-based supplements representing 8-17% of the products used across the ten countries. The prevalence rate reported here can be compared to rates from surveys conducted in the United States, where data on usage of dietary supplements, including herbal supplements, is collected more routinely. It is similar to the rate reported in the 2002 and 2007 National Health Interview Surveys (NHIS), 18.9% and 17.9% respectively (Wu et al. 2011); higher than the rates of both the Eisenberg’s survey (Eisenberg et al. 1998) and the Slone survey (Kauffman et al. 2002), with 14% and 12.1% respectively; and lower than the 2002 Health and Diet Survey (42%) (Timbo et al. 2006) or the 1999 Kaiser Permanent Medical Care Program of Northern California (KPMCP), with a prevalence of 28.3% (Schaffer et al. 2003). These differences in prevalence across studies may in part be due to the distinct selected population samples, survey methodologies (i.e. sampling methods, data collection techniques) or definitions of Research: Chapter 3 152 usage, as well as possible variations in health beliefs and health behaviour of the different populations of study (Vargas-Murga et al. 2011; Dwyer et al. 2013). Survey respondents were recruited to set quotas for both age and gender to reflect characteristics previously reported for dietary supplement users. Age and gender are significant determinants of the consumption of dietary supplements in general and in botanical products in particular. Previous studies on the use of dietary supplements or other herbal-related use show a higher consumption among women as compared to men (Menniti-Ippolito et al. 2002; NCHS 2009; Schaffer et al. 2003; Messerer et al. 2001; Nilson et al. 2001; Nielsen et al. 2005; Thomas et al. 2001) and a higher consumption among older adults as compared to younger adults (Schaffer et al. 2003; Foote et al. 2003; Radimer et al. 2004; Kelly et al. 2005; Bailey et al. 2013). Other characteristics of dietary supplements users that have been reported previously in the literature include having higher educational attainment and socioeconomic status (Schaffer et al. 2003; Rock 2007; Block et al. 2007), being less likely to smoke (Harrison et al. 2004; Bailey et al. 2013; Touvier et al. 2009), being more physically active (Harrison et al. 2004; Foote et al. 2003; Bailey et al. 2013). Bailey et al. (2013) also reported a moderate alcohol consumption (1 drink per day) among dietary supplement users as compared to nonusers. In contrast, a study by Rovira et al. in a southern European population found no differences in lifestyle factors such as physical activity, smoking, and alcohol consumption between dietary supplement users and non-users (Rovira et al. 2013). Our survey population consists exclusively of PFS consumers, but their responses to a series of questions on health-related lifestyle factors reflect some of the characteristics mentioned above. The majority of PFS consumers perceived their health status to be “very good or good”, reflecting results reported in a number of studies on dietary supplement users (Bailey et al. 2013) and CAM and dietary supplement users (Schaffer et al. 2003), where the answer “very good or excellent” has been reported for self-reported health status. The survey results indicate that most consumers reported using one PFS product in the preceding 12 months, with 12% using two products and 4% using more than two. Individual country data show that Finnish consumers use more than one product and PFS with more than one botanical component, and the opposite is observed in the United Kingdom, where about 90% of the consumers use only one PFS and the products contain mostly only one botanical. In the United States, recent studies have reported that about half of the adults report using one or more dietary supplements Research: Chapter 3 153 (Bailey et al. 2013; Picciano et al. 2007). One of these studies also found that over half of dietary supplement consumers used a single-botanical product and one third used one multi-botanical product (Bailey et al. 2013). Similar results were found in our survey across all countries i.e. smaller numbers of consumers reported using two or more single-botanical products (4.4%) and two or more singleand multi-botanical products (11.9%). A wide variety of botanicals (491) is used in PFS consumed by the respondents in this survey. Overall raw data show that the most frequently (n>100) used botanicals in descending order are Ginkgo biloba (ginkgo), Oenothera biennis (evening primrose), Cynara scolymus (artichoke), Panax ginseng (ginseng), Aloe vera, Foeniculum vulgare (fennel), Valeriana officinalis (valeriana), Glycine max (soybean), Melissa officinalis (lemon balm), Echinacea purpurea (echinacea) and Vaccinium myrtillus (blueberry). These results reflect some commercial data which reported that ginkgo followed by echinacea, garlic and ginseng were the four most commercially important botanicals in the combined markets of seventeen EC Member States. In this data, echinacea and ginkgo were part of the composition of products registered as medicines (EAS 2007; Vargas-Murga et al. 2011), which were excluded from our survey. Similarly, the US Food and Drug Administration 2002 Health and Diet Survey, also a 12-month retrospective study, reported the same four herbs/botanicals/or other nonvitaminnonmineral dietary supplements being the most used by its adult population – although in the following order: echinacea, garlic, ginkgo and ginseng (the latter including tea) (Timbo et al. 2006). Schaffer et al. also reported echinacea as the most consumed botanical in the Californian 1999 KPMCP survey, followed by ginkgo (Schaffer et al. 2003). Differences between countries are more evident; the top list of botanicals contained in PFS for each single country complies little with the ranking of the overall data. As mentioned earlier, data were not weighted by country population size because of the study methodology which included very similar country-sample sizes of PFS consumers only, therefore caution is needed when drawing conclusions from these results at the overall 6-country level. Overall data merely describes the collected pooled data from all 6 countries. However, if the overall ranking data were to be weighted by the population size -for example the 1-5 ranking data-, the positions of the botanicals would have been only slightly altered, with Oenothera biennis (evening primrose) being the most consumed one, followed by Cynara scolymus (artichoke) Ginkgo biloba (ginkgo), Panax ginseng (ginseng) and Aloe vera (aloe). The results of the survey highlight clear differences between countries in terms of the botanicals used by consumers as PFS. This may reflect the fact that the current legal Annex III_PlantLIBRA PFS consumer questionnaire 256  Yϰϴ,ŽǁŽĨƚĞŶĚŽLJŽƵĐŽŶƐƵŵĞŽƌŐĂŶŝĐĨŽŽĚƐ ;ŽŶĞĂŶƐǁĞƌŽŶůLJͿ  ϭ ůǁĂLJƐ Ϯ DŽƐƚŽĨƚŚĞƚŝŵĞǁŚĞŶƉŽƐƐŝďůĞ ϯ ^ŽŵĞƚŝŵĞƐ ϰ ZĂƌĞůLJ ϱ EĞǀĞƌ   ^DK</E',/d^  Yϰϵ&ƌŽŵƚŚĞĨŽůůŽǁŝŶŐƐŝƚƵĂƚŝŽŶƐǁŚŝĐŚĚĞƐĐƌŝďĞƐLJŽƵǁŝƚŚƌĞƐƉĞĐƚƚŽƐŵŽŬŝŶŐWůĞĂƐĞ ŝŶĐůƵĚĞĐŝŐĂƌĞƚƚĞƐĐŝŐĂƌƐĂŶĚƉŝƉĞƐǁŚĞŶƚŚŝŶŬŝŶŐĂďŽƵƚLJŽƵƌĂŶƐǁĞƌ;ŽŶĞĂŶƐǁĞƌŽŶůLJͿ  ϭ ƵƌƌĞŶƚůLJ/ĚŽŶƚƐŵŽŬĞ;ŐŽƚŽYϱϬͿ Ϯ ƵƌƌĞŶƚůLJ/ƐŵŽŬĞŽĐĐĂƐŝŽŶĂůůLJ;ůĞƐƐƚŚĂŶϭĚĂLJͿͿ ϯ ƵƌƌĞŶƚůLJ/ƐŵŽŬĞĞǀĞƌLJĚĂLJ;ϭŽƌŵŽƌĞĚĂLJͿ;ŐŽƚŽYϱϭͿ   YϱϬ,ĂǀĞLJŽƵĞǀĞƌƐŵŽŬĞĚŝŶƚŚĞƉĂƐƚ;ŽŶĞĂŶƐǁĞƌŽŶůLJͿ  ϭ EŽ/ǀĞŶĞǀĞƌƐŵŽŬĞĚ;ŐŽƚŽYϱϭͿ Ϯ zĞƐ/ƐŵŽŬĞĚůĞƐƐƚŚĂŶϭĚĂLJĨŽƌůĞƐƐƚŚĂŶϲŵŽŶƚŚƐ ϯ zĞƐ/ƐŵŽŬĞĚůĞƐƐƚŚĂŶϭĚĂLJĚƵƌŝŶŐϲŽƌŵŽƌĞŵŽŶƚŚƐ ϰ zĞƐ/ƐŵŽŬĞĚŵŽƌĞƚŚĂŶϭĚĂLJĨŽƌůĞƐƐƚŚĂŶϲŵŽŶƚŚƐ ϱ zĞƐ/ƐŵŽŬĞĚŵŽƌĞƚŚĂŶϭĚĂLJĨŽƌϲŽƌŵŽƌĞŵŽŶƚŚƐ   Yϱϭ,ŽǁůŽŶŐĂŐŽĚŝĚLJŽƵƐƚŽƉƐŵŽŬŝŶŐ;ŽŶĞĂŶƐǁĞƌŽŶůLJͿ  ϭ >ĞƐƐƚŚĂŶϲŵŽŶƚŚƐĂŐŽ Ϯ ϲƚŽϭϮŵŽŶƚŚƐĂŐŽ ϯ DŽƌĞƚŚĂŶϭLJĞĂƌĂŐŽ   Annex III_PlantLIBRA PFS consumer questionnaire 257 /WYͲW,z^/>d/s/dzYh^d/KEE/Z  dŚĞƋƵĞƐƚŝŽŶƐǁŝůůĂƐŬLJŽƵĂďŽƵƚƚŚĞƚŝŵĞLJŽƵƐƉĞŶƚďĞŝŶŐƉŚLJƐŝĐĂůůLJĂĐƚŝǀĞŝŶƚŚĞůĂƐƚϳĚĂLJƐ WůĞĂƐĞ ĂŶƐǁĞƌ ĞĂĐŚ ƋƵĞƐƚŝŽŶ ĞǀĞŶ ŝĨ LJŽƵ ĚŽ ŶŽƚ ĐŽŶƐŝĚĞƌ LJŽƵƌƐĞůĨ ƚŽ ďĞ ĂŶ ĂĐƚŝǀĞ ƉĞƌƐŽŶ WůĞĂƐĞƚŚŝŶŬĂďŽƵƚƚŚĞĂĐƚŝǀŝƚŝĞƐLJŽƵĚŽĂƚǁŽƌŬĂƐƉĂƌƚŽĨLJŽƵƌŚŽƵƐĞĂŶĚŽƵƚƐŝĚĞǁŽƌŬƚŽŐĞƚ ĨƌŽŵƉůĂĐĞƚŽƉůĂĐĞĂŶĚŝŶLJŽƵƌƐƉĂƌĞƚŝŵĞĨŽƌƌĞĐƌĞĂƚŝŽŶĞdžĞƌĐŝƐĞŽƌƐƉŽƌƚ  dŚŝŶŬ ĂďŽƵƚ Ăůů ƚŚĞ ǀŝŐŽƌŽƵƐĂĐƚŝǀŝƚŝĞƐƚŚĂƚLJŽƵĚŝĚŝŶƚŚĞůĂƐƚϳĚĂLJƐ  sŝŐŽƌŽƵƐ ƉŚLJƐŝĐĂů ĂĐƚŝǀŝƚŝĞƐƌĞĨĞƌƚŽĂĐƚŝǀŝƚŝĞƐƚŚĂƚƚĂŬĞŚĂƌĚƉŚLJƐŝĐĂůĞĨĨŽƌƚĂŶĚŵĂŬĞLJŽƵďƌĞĂƚŚĞŵƵĐŚŚĂƌĚĞƌ ƚŚĂŶŶŽƌŵĂůdŚŝŶŬŽŶůLJĂďŽƵƚƚŚŽƐĞƉŚLJƐŝĐĂůĂĐƚŝǀŝƚŝĞƐƚŚĂƚLJŽƵĚŝĚĨŽƌĂƚůĞĂƐƚϭϬŵŝŶƵƚĞƐĂƚĂ ƚŝŵĞ   YϱϮ ƵƌŝŶŐ ƚŚĞ ůĂƐƚ ϳ ĚĂLJƐŽŶŚŽǁŵĂŶLJĚĂLJƐĚŝĚLJŽƵĚŽǀŝŐŽƌŽƵƐ ƉŚLJƐŝĐĂů ĂĐƚŝǀŝƚŝĞƐ ůŝŬĞ ŚĞĂǀLJůŝĨƚŝŶŐĚŝŐŐŝŶŐĂĞƌŽďŝĐƐŽƌĨĂƐƚďŝĐLJĐůŝŶŐ  ͺͺͺͺĚĂLJƐ ϵEŽǀŝŐŽƌŽƵƐƉŚLJƐŝĐĂůĂĐƚŝǀŝƚŝĞƐ;ŐŽƚŽYϱϰͿ   Yϱϯ,ŽǁŵƵĐŚƚŝŵĞĚŝĚLJŽƵƵƐƵĂůůLJƐƉĞŶĚĚŽŝŶŐǀŝŐŽƌŽƵƐƉŚLJƐŝĐĂůĂĐƚŝǀŝƚŝĞƐŽŶŽŶĞŽĨƚŚŽƐĞ ĚĂLJƐ  ͺͺͺͺͺͺŚŽƵƌƐƉĞƌĚĂLJ ͺͺͺͺͺͺŵŝŶƵƚĞƐƉĞƌĚĂLJ ϵϵ ŽŶƚŬŶŽǁEŽƚƐƵƌĞ  dŚŝŶŬĂďŽƵƚĂůůƚŚĞŵŽĚĞƌĂƚĞĂĐƚŝǀŝƚŝĞƐƚŚĂƚLJŽƵĚŝĚŝŶƚŚĞůĂƐƚϳĚĂLJƐDŽĚĞƌĂƚĞĂĐƚŝǀŝƚŝĞƐ ƌĞĨĞƌƚŽĂĐƚŝǀŝƚŝĞƐƚŚĂƚƚĂŬĞŵŽĚĞƌĂƚĞƉŚLJƐŝĐĂůĞĨĨŽƌƚĂŶĚŵĂŬĞLJŽƵďƌĞĂƚŚĞƐŽŵĞǁŚĂƚŚĂƌĚĞƌ ƚŚĂŶŶŽƌŵĂůdŚŝŶŬŽŶůLJĂďŽƵƚƚŚŽƐĞƉŚLJƐŝĐĂůĂĐƚŝǀŝƚŝĞƐƚŚĂƚLJŽƵĚŝĚĨŽƌĂƚůĞĂƐƚϭϬŵŝŶƵƚĞƐĂƚĂ ƚŝŵĞ   YϱϰƵƌŝŶŐƚŚĞůĂƐƚϳĚĂLJƐŽŶŚŽǁŵĂŶLJĚĂLJƐĚŝĚLJŽƵĚŽŵŽĚĞƌĂƚĞƉŚLJƐŝĐĂůĂĐƚŝǀŝƚŝĞƐůŝŬĞ ĐĂƌƌLJŝŶŐůŝŐŚƚůŽĂĚƐďŝĐLJĐůŝŶŐĂƚĂƌĞŐƵůĂƌƉĂĐĞŽƌĚŽƵďůĞƐƚĞŶŶŝƐŽŶŽƚŝŶĐůƵĚĞǁĂůŬŝŶŐ  ͺͺͺͺĚĂLJƐ ϵEŽŵŽĚĞƌĂƚĞƉŚLJƐŝĐĂůĂĐƚŝǀŝƚŝĞƐ;ŐŽƚŽYϱϲͿ    Yϱϱ,ŽǁŵƵĐŚƚŝŵĞĚŝĚLJŽƵƵƐƵĂůůLJƐƉĞŶĚĚŽŝŶŐŵŽĚĞƌĂƚĞƉŚLJƐŝĐĂůĂĐƚŝǀŝƚŝĞƐŽŶŽŶĞŽĨƚŚŽƐĞ ĚĂLJƐ  ͺͺͺͺͺͺŚŽƵƌƐƉĞƌĚĂLJ ͺͺͺͺͺͺŵŝŶƵƚĞƐƉĞƌĚĂLJ ϵϵ ŽŶƚŬŶŽǁEŽƚƐƵƌĞ  dŚŝŶŬĂďŽƵƚƚŚĞƚŝŵĞLJŽƵƐƉĞŶƚǁĂůŬŝŶŐŝŶƚŚĞůĂƐƚϳĚĂLJƐdŚŝƐŝŶĐůƵĚĞƐĂƚǁŽƌŬĂŶĚĂƚŚŽŵĞ ǁĂůŬŝŶŐ ƚŽ ƚƌĂǀĞů ĨƌŽŵ ƉůĂĐĞ ƚŽ ƉůĂĐĞ ĂŶĚ ĂŶLJ ŽƚŚĞƌ ǁĂůŬŝŶŐ ƚŚĂƚLJŽƵŵŝŐŚƚĚŽƐŽůĞůLJĨŽƌ ƌĞĐƌĞĂƚŝŽŶƐƉŽƌƚĞdžĞƌĐŝƐĞŽƌůĞŝƐƵƌĞ  YϱϲƵƌŝŶŐƚŚĞůĂƐƚϳĚĂLJƐŽŶŚŽǁŵĂŶLJĚĂLJƐĚŝĚLJŽƵǁĂůŬĨŽƌĂƚůĞĂƐƚϭϬŵŝŶƵƚĞƐĂƚĂƚŝŵĞ  ͺͺͺͺĚĂLJƐ ϵEŽǁĂůŬŝŶŐ;ŐŽƚŽYϱϴͿ Annex III_PlantLIBRA PFS consumer questionnaire 258   Yϱϳ,ŽǁŵƵĐŚƚŝŵĞĚŝĚLJŽƵƵƐƵĂůůLJƐƉĞŶĚǁĂůŬŝŶŐŽŶŽŶĞŽĨƚŚŽƐĞĚĂLJƐ ͺͺͺͺͺͺŚŽƵƌƐƉĞƌĚĂLJ ͺͺͺͺͺͺŵŝŶƵƚĞƐƉĞƌĚĂLJ ϵϵ ŽŶƚŬŶŽǁEŽƚƐƵƌĞ  dŚĞůĂƐƚƋƵĞƐƚŝŽŶŝƐĂďŽƵƚƚŚĞƚŝŵĞLJŽƵƐƉĞŶƚƐŝƚƚŝŶŐŽŶǁĞĞŬĚĂLJƐĚƵƌŝŶŐƚŚĞůĂƐƚϳĚĂLJƐ/ŶĐůƵĚĞ ƚŝŵĞƐƉĞŶƚĂƚǁŽƌŬĂƚŚŽŵĞǁŚŝůĞĚŽŝŶŐĐŽƵƌƐĞǁŽƌŬĂŶĚĚƵƌŝŶŐůĞŝƐƵƌĞƚŝŵĞdŚŝƐŵĂLJŝŶĐůƵĚĞ ƚŝŵĞƐƉĞŶƚƐŝƚƚŝŶŐĂƚĂĚĞƐŬǀŝƐŝƚŝŶŐĨƌŝĞŶĚƐƌĞĂĚŝŶŐŽƌƐŝƚƚŝŶŐŽƌůLJŝŶŐĚŽǁŶƚŽǁĂƚĐŚƚĞůĞǀŝƐŝŽŶ  YϱϴƵƌŝŶŐƚŚĞůĂƐƚϳĚĂLJƐŚŽǁŵƵĐŚƚŝŵĞĚŝĚLJŽƵƐƉĞŶĚƐŝƚƚŝŶŐŽŶĂǁĞĞŬĚĂLJ ͺͺͺͺͺͺŚŽƵƌƐƉĞƌǁĞĞŬĚĂLJ ͺͺͺͺͺͺŵŝŶƵƚĞƐƉĞƌǁĞĞŬĚĂLJ ϵϵ ŽŶƚŬŶŽǁEŽƚƐƵƌĞ  ;ŶĚŽĨƚŚĞƋƵĞƐƚŝŽŶŶĂŝƌĞdŚĂŶŬƚŚĞŝŶƚĞƌǀŝĞǁĞƌĨŽƌŚĞƌŚŝƐƉĂƌƚŝĐŝƉĂƚŝŽŶͿ ANNEX IV. Articles and posters   $11(;,9D$UWLFOH 2EHVLW\DQGRYHUZHLJKWWUHQGVLQ&DWDORQLD6SDLQJHQGHUDQG VRFLRHFRQRPLFGHWHUPLQDQWV 3XEOLVKHGLQ3XEOLF+HDOWK1XWULWLRQ 1RYHPEHU   Public Health Nutrition: 10(11A), 1368–1378 DOI: 10.1017/S1368980007000973 Obesity and overweight trends in Catalonia, Spain (1992–2003): gender and socio-economic determinants Alicia Garcı ´a-A ´lvarez 1 , Lluı ´s Serra-Majem 1,2,3, *, Lourdes Ribas-Barba 1 , Conxa Castell 3 , Marius Foz 4 , Ricardo Uauy 5 , Antoni Plasencia 3 and Lluı ´s Salleras 6 1 Community Nutrition Research Centre, University of Barcelona Science Park, Baldiri Reixac 4, Torre D 4A1, 08028 Barcelona, Spain: 2 Department of Clinical Sciences, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain: 3 Division of Public Health, Department of Health, Generalitat of Catalonia, Barcelona, Spain: 4 Department of Internal Medicine, Autonomous University of Barcelona, Barcelona, Spain: 5 London School of Hygiene and Tropical Medicine, London, England: 6 Department of Public Health, University of Barcelona, Barcelona, Spain Submitted 6 July 2007: Accepted 7 September 2007 Abstract Objective: To evaluate the trends of overweight and obesity prevalences in the population of Catalonia, Spain, aged 18–75 years, and the influence of socio-economic determinants on these prevalence trends. Design: Analysis based on data from two representative population-based cross-sectional surveys. Setting: Data from the two Evaluations of Nutritional Status in Catalonia (ENCAT 1992–93 and ENCAT 2002–03), Spain. Weights and heights were obtained by direct measurement in standardised conditions by trained interviewers. Overweight and obesity were defined using body mass index (BMI) and waist circumference (WC), categorised according to WHO criteria. Subjects: In total, 1015 men and 1233 women from ENCAT 1992–93, and 791 men and 924 women from ENCAT 2002–03. Results: Mean BMI and mean WC were higher in males in 2002–03 as compared to 1992–93, while for females mean BMI was lower except for the youngest group, and mean WC was higher. In men, overall BMI overweight prevalence remained stable (from 44.1% to 43.7%), while obesity increased (from 9.9% to 16.6%); total WC overweight remained stable (from 21.7 to 23.8%), while WC obesity increased (from 13.1% to 24.4%). In women, overall BMI overweight increased (from 29.1% to 30.1%), whereas BMI obesity remained stable (from 15.0% to 15.2%); total WC overweight decreased (from 21.8% to 17.7%), while WC obesity increased (from 24.5% to 31.1%). The socio-economic and education variables had an influence on BMI and WC overweight and obesity rates mainly on females in both surveys and on the youngest men only in the 1992–93 survey. Conclusions: Ten-year trends indicate that Catalan males are getting bigger overall (BMI) and around the waistline (WC), while Catalan females only have bigger waistlines (WC). BMI male obesity prevalence has overtaken that of females. WC obesity continues to be more prevalent among females than males. Keywords Obesity Overweight Prevalence Adults Socio-economic determinants Cross-sectional survey Trends Overweight and obesity are recognised as public health problems worldwide and as major causes of preventable ill health 1 . Total obesity is the sixth most important risk factor contributing to the overall burden of disease worldwide, being a major risk factor for chronic noncommunicable diseases such as hypertension, coronary heart disease, type 2 diabetes, dyslipidaemia, as well as to some hormone-dependent cancers 2 . Abdominal obesity is a strong predictor of coronary heart disease and related risk factors 3 . Overweight and obesity also have an important health cost associated with them 2 . The World Health Organisation (WHO) recently reported 1.1 billion overweight individuals and 300 million obese individuals 1 , 10% of which are overweight or obese children 4 . Overweight and obesity prevalence rates are increasing in both developed and developing societies 1 . The WHO reported that, since 1980, obesity prevalence rates have increased threefold in Northern *Corresponding author: Email [email protected] rThe Authors 2007 America (in the United States over 65% of adults are now overweight or obese 5 ), the United Kingdom, Central and Eastern Europe, Pacific Islands, Australia and China 1 . In Spain, adult, adolescent and child obesity prevalence has also increased in the last decade 6,7 . The group of children aged between 6 and 13 years and the group of women aged over-45 years are the groups with the highest risk of obesity; obesity prevalence is higher among males during years of growth and development 6,7 , while in the over 45-year group it is significantly higher in females 6,8 . In a recent study in Southern Spain, the authors found that a larger proportion of men were overweight compared to women, but the opposite was found for obesity 9 . In 2004, the results from the DORICA Study 10 showed that the obesity prevalence of the NorthEastern region of Spain (which includes Catalonia) was 8.5% for men and 13.8% for women, which were the lowest out of the eight regions included in the study 6 . Numerous studies have shown that obesity is more frequent in the less socially advantaged population groups, regardless of the variable used to classify socioeconomic status (SES); these differences in the prevalence of obesity by SES have been observed in both men and women, but are stronger and more consistent in women 11 . The WHO’s MONICA Study showed that the prevalence of obesity is higher among adults and children of low SES 12 . In Spain, in 1987, a group of researchers found a higher prevalence of obesity among the population of a lower educational level 8 ; in the period 1987–97, the same researchers found a higher obesity prevalence in individuals with elementary education, and that the obesity prevalence proportion associated with elementary education increased in women and decreased in men 13 . Moreover, the SEEDO’97 Study in Spain showed higher obesity rates in men and women with low educational level, and also that older women with low educational level and low income seemed to be the most susceptible group to weight gain 2 . Adding to this evidence, a significant inverse relationship between SES and overweight and obesity was found by the AVENA (Alimentacio ´n y Valoracio ´n del Estado Nutricional de los Adolescentes Espan ˜oles) Study 14 , although only in male adolescents. Overweight and obesity also have a sociodemographic component. In this respect, the SEEDO’97 Study in Spain also showed differences in the distribution of the obesity prevalence by area of residence and geographical zones 15 . Other well-known factors that influence the development of obesity are physical inactivity 16,17 , overconsumption of energy-dense diets (which has been shown to be associated with low SES) 18 and genetic factors (although some authors do not agree to this) 5 . The objective of the present paper is to evaluate the trends (1992–2003) of overweight and obesity prevalences in the 18–75-year-old population of Catalonia, Spain, and the influence of socio-economic and sociodemographic determinants on these prevalence trends. Material and Methods Sample and subjects The data analysed in this paper belong to the 1992–93 and the 2002–03 cross-sectional Evaluations of the Nutritional Status of the Catalan Population (ENCAT 1992–93 and ENCAT 2002–03) 15,19 . ENCAT is a regional survey carried out periodically by the Department of Health of the Catalan Government and co-ordinated by the Centre for Research on Community Nutrition of the University of Barcelona. The theoretical random sample population and sample size have been described elsewhere 15,19 , comprising the population source of residents in the official census. The samples were stratified according to household and randomised into subgroupings with municipalities being the primary sample units, and individuals within these municipalities comprising the final sample units. The valid response rate for the first survey was 69% and for the second 65%. Adults from each representative sample within the age of 18–75 years were included in the analysis of this study (nin ENCAT 1992–93 52248 and nin ENCAT 2002–03 51715). Data collection procedures and variables of the study In both surveys, dietitians were trained on standardisation of criteria and methodology before data collection, in order to reduce inter-observer measurement variability. The data were collected from 1992 to 1993 and from 2002 to 2003 through questionnaires and anthropometric measurements during a home interview. In order to analyse the influence of the socio-economic determinants on the prevalence of overweight and obesity, the following variables were used and rearranged according to the following categories 2 : 1. Socio-economic level (SEL) (occupation of the subject): (a) low: the non-classifiable, army, agricultural sector, service sector and non-qualified labourers; (b) medium: qualified labourers, foremen, rest of administrative, commercial and technical staff and medium-level technicians; (c) high: high-level technicians, directors/ managers, self-employed professionals, business owners or self-employed individuals without staff, business owners or self-employed individuals with staff. 2. Education level of the subject and of the family’s head member (ELS and ELH): (a) low: primary school incomplete or illiterate (,6 years at school); (b) medium: primary school completed, secondary school or further education (6–12 years of education); (c) high:high school, college or university degree (.12 years of education). Obesity and overweight trends in Spain (1992–2003) 1369 The sociodemographic determinants included (1) gender, (2) age group (18–24, 25–44, 45–64 and 65–75 years) and (3) population of residence size (,10,000 inhabitants, 10,000–100,000 inhabitants and .100,000 inhabitants). Anthropometric measurements Body mass index Weight and height were measured with a portable spring scale and a metric tape (Kawe r model). The individuals were measured in standardised conditions, wearing underwear and no shoes. Weight was measured in kilograms, scale measurement error 6100 g. Height was measured standing and head in the Frankfurt horizontal position, expressed in centimetres, instrumental measurement error 60.1 cm. Body mass index (BMI) was calculated using weight and height and categorised according to WHO criteria 20 so that overweight was defined as BMI $25.0 to BMI ,30.0 kg m 22 and obesity as BMI $30 kg m 22 . Waist circumference Waist circumference (WC) was measured with a nonelastic metric tape halfway between the lower border of the ribs and the iliac crest on a horizontal plane. Measurements were recorded to the nearest 0.1 cm and categorised according to WHO criteria, so that men with a WC 94.0–101.9 cm and women with a WC 80.0–87.9cm were classified as overweight, and men with a WC $ 102.0 cm and women with a WC $88.0 cm were classified as obese 20 . Statistical analysis All analyses were performed with SPSS 12.0. Proportions of overweight and obesity were estimated for each sample separately and stratified by gender and age (to control for its potential confounding effects). The age distribution of the whole Catalan population in 1992–93 was used as a reference. The proportions from the two surveys were compared using the x 2 statistic test and the means were compared using the t-test, considering P-values ,0.05 for significance. Results The sample characteristics of the two surveys are presented in Table 1: the total number of subjects by gender, age group and each socio-economic/sociodemographic variable category. Table 2 shows the mean, standard deviations and 5th–95th percentiles of BMI and WC by gender and age group. In 2002–03, male mean BMI was higher than in 1992–93, although the observed difference was significant only for individuals aged 25–44 years (from 25.2 to 25.9) and 45–64 years (from 26.7 to 27.4), and male mean WC was significantly higher in all age groups; for females the observed decreasing trends in mean BMI in most age groups (except for the youngest) were not significant, while mean WC was significantly higher only in the youngest (from 70.3 to 72.7) and eldest (from 92.2 to 95.3) individuals. These results are shown in Figs 1 and 2, which also show how mean BMI and WC increase as age progresses in both genders. Percentiles 50, 75 and 95 of BMI showed increases in males from all age groups and decreases in females (except for the youngest group). As for WC, percentiles 50, 75 and 95 showed increases in males and females of all age groups. Table 3 shows overall by-gender and by-survey BMI and WC overweight and obesity prevalences; it can be observed that the overall prevalence of BMI obesity increased significantly only in males (6.7 percentage points, from 9.9% to 16.6%) in the 10-year period, while that of WC obesity increased in both sexes (11.3 percentage points for males – from 13.1% to 24.4%, and 6.6 for females – from 24.5% to 31.1%). Table 3 also shows BMI and WC overweight and obesity prevalences when age, SEL, education level and population of residence size are considered. When considering the variable ‘age’, Table 3 shows that in ENCAT 1992–93, the highest prevalence of BMI overweight was found in both males and females aged 45–64 years, which was also the case for female but not for male WC overweight; while in ENCAT 2002–03, only an increase in female BMI overweight and male WC overweight were observed with progressing age. Regarding obesity, both surveys showed an increase in the prevalence of BMI and WC obesity with progressing age in both sexes (note the high prevalence of WC obesity among the eldest men and women in 2002–03, 49.6% and 70.9% respectively). The between-survey comparison showed significant changes only in male BMI overweight and male WC obesity rates, demonstrating alarming increases in the latter rates (i.e. from 1.3% to 6.0% in the 18–24-year-old group). Regarding the variable ‘socio-economic level’ (SEL), the differences observed in BMI and WC overweight and obesity prevalences of the different SEL groups were significant only in females of both surveys, WC obesity being highest in the low SEL group (Table 3). In ENCAT 1992–93, SEL was inversely related to the prevalence of BMI obesity, but only significantly in females; this inverse relationship was not observed among SEL groups in ENCAT 2002–03. WC obesity was only inversely related with SEL in females of both surveys and the differences among SEL groups were significant (Table 3). The between-survey comparison showed significant increases in male BMI and WC obesity (from 8.3% to 16.5% and from 13.3% to 26.3%) and female WC obesity (from 15.3% to 19.3%). With regard to the variable ‘education level of the subjects’ (ELS), in ENCAT 2002–03, Table 3 shows an 1370 A Garcı ´a-A ´lvarez et al. those that offer the most dietary energy at the lowest cost. The relative cost has also been taken into account in the literature which increases even further the cost of the healthy diet for the low-income families 26 . The present study has not considered diet, physical activity, income (at least not directly), expenditure on food or food costs in its analysis (which was merely descriptive and far from suggesting causality due to the cross-sectional nature of the data); therefore, the authors recognise the need for a further and more robust analysis that involves all these lifestyle variables known to affect the relationship between prevalence of excess body weight and SES. In addition, self-reported occupation and education level may be over or under estimated. However, this probably has not significantly modified the classification of the participants into the three SES groups. Moreover, this study has not adjusted WC for BMI, which should be done due to the influence a high BMI can have on a high WC 21 . In spite of the mentioned limitations, we believe that our findings contribute to the evidence needed to guide public health policy makers in the design and implementation of preventive campaigns against the increasing trends of overweight and obesity, paying special attention to males and low SEL and educationlevel groups, and small population of residence size (for male overweight and female obesity). Acknowledgements Sources of funding: This work was made possible by financing from the General Division of Public Health of the Generalitat of Catalonia’s Department of Health, through a research agreement with the Fundacio ´n para la Investigacio ´n Nutricional (Nutrition Research Foundation). Conflict of interest declaration: None of the authors had any conflicts of interest in connection with this study. Authorship responsibilites: AGA was responsible for the statistical analysis, data interpretation and writing of the paper; LSM was director of the study and revised the paper providing expert advice on data interpretation and discussion of the paper; LRB was coordinator of the study and responsible of the databases and revised the paper providing expert advice on data interpretation; CC participated in the study concept and design; MF, RU, AP and LS revised the paper providing expert advice in its discussion. Guarantor: Lluı ´s Serra-Majem. Acknowledgements: Part of this analysis belongs to Alicia Garcı ´a-A ´lvarez’s MSc thesis at the London School of Hygiene and Tropical Medicine (2004–05) supervised by Ricardo Uauy. Special acknowledgement is made to all those persons who were interviewed, and whose collaboration made the realisation of these surveys possible. Research Group on the Evaluation and Monitoring of the Nutritional Status in the Catalan Population: Lluı ´s Serra-Majem, Director (University of Las Palmas de Gran Canaria); Lourdes Ribas-Barba, Coordinator (FIN-Nutrition Research Foundation, Barcelona Science Park); Gemma Salvador (Generalitat of Catalonia); Conxa Castell (Generalitat of Catalonia); Blanca Roma ´nVin ˜as (FIN, Barcelona Science Park); Jaume Serra (Generalitat of Catalonia); Lluı ´s Jover (University of Barcelona); Ricard Tresserras (Generalitat of Catalonia); Blanca Raido ´(FIN, Barcelona Science Park); Andreu Farran (CESNID, University of Barcelona); Joy Ngo (FIN, Barcelona Science Park); Mari Cruz Pastor (Hospital Germans Trias i Pujol, Badalona); Lluı ´s Salleras (University of Barcelona); Ricardo Uauy (London School of Hygiene and Tropical Medicine (England), and Carmen Cabezas, Josep Lluı ´s Taberner, Salvi Junca `, Josep Maria Aragay, Gonc¸al Lloveras Valle `s(y2003), Antoni Plasencia (Generalitat of Catalonia). 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   3HUFHQWVHGHQWDU\RFFXSDWLRQDOSK\VLFDODFWLYLW\       7RWDOHQHUJ\LQWDNHNFDOG       3HUFHQWORZIUXLWYHJHWDEOHFRQVXPSWLRQJG       3HUFHQWKLJKHWKDQROFRQVXPSWLRQOHYHO       9DOXHVDUHSURSRUWLRQVRUPHDQV6(DVVKRZQ  D /RZRFFXSDWLRQDOVRFLDOFODVVGHILQHGEDVHGRQWKHKRXVHKROGKHDGVRFFXSDWLRQEHLQJPDQXDORUXQVNLOOHGZRUNHUVDVZHOODVIDUPHUVRUILVKHUPHQ  E /RZHGXFDWLRQOHYHOGHILQHGDV\HDUVRIVFKRROLQJIRUHDFKLQGLYLGXDO  F /RZKRXVHKROGKHDG++HGXFDWLRQOHYHOGHILQHGDV\HDUVRIVFKRROLQJ   Table 3. 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The appointments of those willing to participate were later reconfirmed by phone. The data were made anonymous when recorded electronically i.e. the respondents’ contact details were not entered into the survey database. Instead, the market research organization assigned ID numbers to each respondent and provided PlantLIBRA partners only the database with the assigned ID numbers. Definition of plant food supplements in the PlantLIBRA PFS consumer survey Although there is a legal definition of Food Supplements (EU Directive (2002/46/EC) [6] under which PFS reside, for the purposes of this research it was necessary to develop a specific definition of PFS whose main characteristic is that they contain botanical preparations as ingredients for food supplementation. Botanical preparations are obtained by subjecting botanicals (plants, algae, fungi or lichens) to treatments such as comminution, extraction, distillation, squeezing, fractionation, purification, concentration or fermentation. These include extracts, essential oils, expressed juices, powders, etc. Botanical preparations can be considered as nutrients or other substances. Thus, the definition of PFS for the survey was as follows: PFS are "foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of botanical preparations that have nutritional or physiological effect, alone or in combination with vitamins, minerals and other substances which are not plant-based. PFS are marketed in dose form, such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities’’. Products that did not meet this definition, such as herbal remedies and other medicinal products based on botanicals, and those that did not meet the PFS definition in terms of dosage, such as herbal teas or juices, were excluded. Sample population and PFS consumer definition A cross-sectional, 12-month retrospective survey was conducted in 24 cities in six European countries -Finland, Germany, Italy, Romania, Spain and the United Kingdom. An estimated sample size of 2000 screened individuals per country was calculated in order to obtain a final sample of approximately 400 consumers per country (total N = 2400 approximately). Per country, gender and age group quotas were set as follows: 300 adults (18 to 59 years) and 100 older adults (60-and-over years), with 30–50% male and 50–70% female. All individuals were screened by means of a brief questionnaire which recorded PFS usage in the preceding 12 months. Individuals were considered eligible for inclusion if they were over 18 years old and met either of the following specified criteria, intended to capture the different usage patterns of PFS consumers: 1) They had taken at least 1 PFS in the last 12 months, in an appropriate dose form at a minimum frequency of either: a) 1 daily dose for at least 2 consecutive or non-consecutive weeks, or b) 1 or more doses per week for at least 3 consecutive weeks or c) 1 or more doses per week for at least 4 consecutive or non-consecutive weeks 2) They had taken 2 or more different PFS, in an appropriate dose form, at a minimum frequency of 1 or more doses per Table 5. PlantLIBRA’s PFS consumer survey – PFS usage patterns, per product used by a respondent, overall and by gender and age group. Gender Age group Total (n = 2874) Male (n = 1358) Female (n = 1516) 18–59 years (n = 2131) $ $ 60 years (n = 743) n% (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) I took it whenever/sporadically 568 19.8 (18.3–21.2) 280 20.6 (18.5–22.8) 288 19.0 (17.0–21.0) 437 20.5 (18.8–22.2) 131 17.6 (14.9–20.4) I take it periodically, during those times only 1072 37.3 (35.5–39.1) 533 39.3 (36.7–41.9) 539 35.6 (33.1–38.0) 827 38.8 (36.7–40.9) 245 33.0 (29.6–36.46) I took it when I had a flare up/worsening of condition 638 22.2 (20.7–23.7) 278 20.5 (18.3–22.6) 360 23.8 (21.6–25.9) 451 21.2 (19.4–22.9) 187 25.2 (22.1–28.3) Other reason 512 17.8 (16.4–19.2) 224 16.5 (14.5–18.5) 288 19.0 (17.0–21.0) 353 16.6 (15.0–18.1) 159 21.4 (18.5–24.4) Not sure 84 2.9 (2.3–3.5) 43 3.2 (2.2–4.1) 41 2.7 (1.9–3.5) 63 3.0 (2.2–3.7) 21 2.8 (1.6–4.0) Questions asked. During the last 12 months, in what months have you taken this supplement? (mark all that apply). Possible responses : Jan, Feb, Mar, Apr, May, June, July, Aug, Sep, Oct, Nov, Dec, All year round; Why did you decide to take this supplement in the months stated? (one answer only). Possible responses : I took it whenever/sporadically; I take it periodically, during those times only; When I had a flare up/worsening of condition; Other reason; Not sure. doi:10.1371/journal.pone.0092265.t005 Usage of Plant Food Supplements by European Adults PLOS ONE | www.plosone.org 6 March 2014 | Volume 9 | Issue 3 | e92265 week, with the sum of the usage period of the 2 or more products being equal to at least 4 weeks. Instruments and variables A short screening questionnaire was used to identify consumers who met the survey inclusion criteria; it consisted of six questions which allowed interviewers to identify eligible consumers, based on the product(s) used, the frequency and duration of use and the dose form. Eligible consumers subsequently completed a more detailed questionnaire on their PFS usage in the preceding 12 months, providing details of product/plant names, dosage forms, frequency of use, reasons for use, adverse effects, places and patterns of purchase and information sources on products. These questions were asked for each of up to a maximum of 5 different PFS used. In addition, respondents were asked to provide sociodemographic data including age, gender, level of education and employment status, as well as self-reported height and weight and further health-related lifestyle information. Survey administration and data collection Fieldwork and data collection for the cross-sectional survey were conducted by the international market research company EFG, from May 2011 to September 2012. The duration of the fieldwork ensured that any seasonal variability in usage of products was captured. The survey protocols and instruments -training material, information sheet, informed consent, screening and usage questionnaires-, were initially developed in English by consensus amongst the research team, and subsequently translated into the respective languages in each of the survey countries. Pilot interviews were conducted in each participating country to assess the comprehension of the questions and to determine the time required to complete the survey. In each participating country, trained interviewers systematically screened approximately 1000 individuals during the first three months of the survey, which allowed the estimation of the prevalence rate. Subsequently, screening and recruitment were conducted on a convenience basis. The recruited eligible consumers were interviewed face-to-face and the more detailed PFS usage questionnaire completed. Data preparation and statistical analysis All data from the completed surveys were entered into the statistical package SPSS for Windows v. 18 (IBM Corporation, Somers, NY, USA), which was also used for data analysis. Following review of the completed interviews by the research team in each country, a database with botanical composition data for all PFS products reported was compiled for each country and then merged into a single database. Potential product duplicates between countries were not removed. Each product was coded for its botanical ingredients in scientific, English and local names and botanicals were coded after removing duplicates between countries. Additionally, each product was categorised as a singleor multi-botanical product. To indicate the certainty of the matching of products, a series of numerical codes were used, based on those used in the National Health and Nutrition Examination Survey 2005–2006 [17]. Values ranged from 1–5, where ‘‘1’’ indicated an exact match, ‘‘2’’ a probable match, ‘‘3’’ a reasonable match, ‘‘4’’ a default match and ‘‘5’’ no match. Only products with certainty values 1 to 4 have been included in the analyses. Respondent data were recorded in a separate database. A number of variables were created and/or recoded to facilitate reporting and analysis, including: 1) ‘‘education level’’, defined as low, medium, and high; 2) ‘‘BMI’’, which was calculated from self-reported weight Table 6. PlantLIBRA’s PFS consumer survey – PFS usage patterns, per product used by a respondent, overall and by country. Finland (n = 665) Germany (n = 446) Italy (n = 417) Romania (n = 464) Spain (n = 465) United Kingdom (n = 417) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) I took it whenever/sporadically 83 12.5 (10.0–15.0) 102 22.9 (19.0–26.8) 73 17.5 (13.9–21.2) 60 12.9 (9.9–16.0) 105 22.6 (18.8–26.4) 145 34.8 (30.2–39.4) I take it periodically, during those times only 307 46.2 (42.4–50.0) 226 50.7 (46.0–55.3) 172 41.3 (36.5–46.0) 194 41.8 (37.3–46.3) 68 14.6 (11.4–17.8) 105 25.2 (21.0–29.4) I took it when I had a flare up/worsening of condition 126 19.0 (16.0–21.9) 89 20.0 (16.2–23.7) 128 30.7 (26.3–35.1) 117 25.2 (21.3–29.2) 75 16.1 (12.8–19.5) 103 24.7 (20.6–28.8) Other reason 140 21.1 (18.0–24.2) 26 5.8 (3.7–8.0) 32 7.7 (5.1–10.2) 51 11.0 (8.1–13.8) 214 46.0 (41.5–50.6) 49 11.8 (8.7–14.9) Not sure 9 1.4 (0.5–2.2) 3 0.7 (0.0–1.4) 12 2.9 (1.3–4.5) 42 9.1 (6.4–11.7) 3 0.7 (0.0–1.4) 15 3.6 (1.8–5.4) Questions asked. During the last 12 months, in what months have you taken this supplement? (mark all that apply) Possible responses : Jan, Feb, Mar, Apr, May, June, July, Aug, Sep, Oct, Nov, Dec, All year round; Why did you decide to take this supplement in the months stated? (one answer only) Possible responses : I took it whenever/sporadically; I take it periodically, during those times only; When I had a flare up/worsening of condition; Other reason; Not sure. doi:10.1371/journal.pone.0092265.t006 Usage of Plant Food Supplements by European Adults PLOS ONE | www.plosone.org 7 March 2014 | Volume 9 | Issue 3 | e92265 and height, and for which WHO criteria [18] were used to categorise individuals as underweight (BMI,18.5 kg/m 2 ), normal weight (BMI 18.5-,25 kg/m 2 ), overweight (BMI 25-,30 kg/m 2) and obese (BMI $30 kg/m 2 ); 3) ‘‘physical activity’’, calculated using the short version of the IPAQ [19] and defined as low, moderate or high. Absolute frequencies and percentages for each of the variable categories were used to describe the qualitative nominal/ordinal and discrete quantitative survey data. In turn, all data have been stratified by gender, age range and country - also using absolute frequencies and percentages and 95% confidence intervals. When describing the association between two qualitative variables (nominal or ordinal), contingency tables were used. The continuous quantitative variables (e.g. BMI, alcohol) were recoded into categorical variables. It is important to note that when reporting the main results of the survey, the unit of analysis varies depending on the variables used, i.e. for certain variables the unit is an individual respondent, however, given the potential intake of multiple supplements by one respondent, the unit of analysis may change to the supplement level. Furthermore, all results presented in the tables represent the analysis of raw data as opposed to data weighted by the population size. Data were not weighted because of the study methodology selected, whereby all country samples were very similar in size and included only PFS consumers. Validation study In order to validate the PFS usage questionnaire, a validation study was conducted in which the data collected using the survey instrument were compared with a 30 to 180-day diary (used as the gold standard). The study was conducted in two of the PlantLIBRA consumer survey cities: Las Palmas de Gran Canaria (Spain) and Milan (Italy), where 48 and 49 consumers respectively were recruited using convenience sampling. The PFS usage questionnaire was completed by the respondents at the beginning and at the end of the 6-month period of the validation; during this time the consumers also completed the usage diary. Data from the last questionnaire and the diary were compared for concordance, and results are shown in Table 1, indicating a good agreement for product consumed, dose form and doses per day. Results Characteristics of the PFS consumer sample A final sample of 2359 consumers (those eligible and willing to participate) was recruited from 11783 screened individuals (Table 2). Due to different legal frameworks (different distribution of botanicals in food supplements and medicinal products), more individuals had to be screened in Finland in order to recruit the required 400 consumers. Table 2 also shows the sample used for the estimation of the usage prevalence rate. The estimated weighted overall PFS usage prevalence rate was 18.8% and percountry rates were as follows: Finland 9.6%, Germany 16.9%, Italy 22.7%, Romania 17.6%, Spain 18.0% and the United Kingdom 19.1%. Survey respondents were recruited to fixed quotas for age and gender, which were achieved, with some differences within countries (Table 3). In Finland the proportion of adults aged 50–59 years was significantly higher (26.2%), whilst the opposite was true in Italy, where consumers in that age group constituted only 13.0% of adults. Romania had a significantly higher number of consumers in the youngest age group (30.5%), in contrast to Spain and the United Kingdom, where this age group represented only 9.5% and 9.0% of adult consumers, respectively. A significantly higher proportion of female consumers were recruited in Spain (56.7%) and in the United Kingdom marginally more males were recruited (50.3%). Across all countries, more than half of the participants (57.5%) were employed (Table 3), with the percentages slightly lower in Finland (50.9%) and in the United Kingdom (52.4%). The majority of participating consumers were educated to medium level (Table 3). Respondents were asked a number of questions regarding health-related lifestyle factors (Table 4). Less than half of the consumers had never smoked (46.6%), less than one quarter were ex-smokers (23.1%) and less than one third were current smokers (30.3%). More than half of the total respondents (59.3%) had not consumed alcohol or had consumed it less than once daily; more than a tenth (12.6%) reported daily alcohol consumption. The proportion of overweight and obese people in the survey was 49.8% (Table 4). Some significant differences in levels of physical activity were noted between countries. High levels of activity were reported by 85.5% of Romanian respondents compared to a value of 42.9% across all countries. Most of the respondents (65.1%) reported not being regular consumers of food supplements other than PFS in the preceding 12 months, except for Finland (Table 4). The proportion of nonconsumers varied from 20.7% in Finland to more than 80% in the United Kingdom and Italy. By contrast, in Finland 76.3% of the individuals were regular consumers of food supplements. Over half of all respondents (59.5%) reported not having used CAM therapies/treatments in the past year. This is particularly the case in Italy (74.6%), Romania (80.8%) and the United Kingdom (92.6%). Three quarters of consumers reported their health status as very good or good (75.5%), while 3.6% reported it as bad or very bad and 21.0% as neither bad nor good (Table 4). Between countries, more consumers reported their health status as very good or good in Romania (81.3%) and in the United Kingdom (81.1%) than in other countries; though conversely the highest proportion reporting their health status as bad or very bad was also in the United Kingdom (7.6%). Table 7. PlantLIBRA’s PFS consumer survey – Characteristics of PFS reported by respondents. Total Finland Germany Italy Romania Spain United Kingdom Number of products 1288 213 190 289 196 284 116 Number of botanicals 491 196 191 222 219 218 47 Number of manufacturers 449 69 99 106 61 97 17 Maximum number of ingredients per product 46 23 46 20 39 30 8 doi:10.1371/journal.pone.0092265.t007 Usage of Plant Food Supplements by European Adults PLOS ONE | www.plosone.org 8 March 2014 | Volume 9 | Issue 3 | e92265 PFS usage patterns Overall, products are most often taken ‘‘periodically’’ (37.3%) with respondents also reporting using PFS when experiencing a ‘‘flare up or worsening of a condition’’ (22.2%) (Table 5). Products are also used on a more ‘‘sporadic basis’’ (19.8%) and on ‘‘other non-specified occasions’’ (17.8%). Both men and women reported taking products on a periodic basis (39.3%, 35.6%) and this was also true for both age groups (Table 5). Periodic use was reported significantly more often in Finland (46.2%), Germany (50.7%), Italy (41.3%) and Romania (41.8%), but in Spain, ‘‘another reason’’ was most reported (46.0%) and in the United Kingdom, sporadic use (34.8%) was significantly higher than any other reason as to when products were used (Table 6). PFS products used Respondents reported a total of 1288 products across the six countries. At individual country level, the highest numbers of different PFS were used in Italy (289) and Spain (284); in the United Kingdom, the number of different PFS was approximately half that of the other countries (Table 7). The number of different botanical ingredients was 491, with the maximum number of different botanicals contained in a single product being 46 and present in a German product. The United Kingdom differed from the other countries as the products reported contained a lower number of botanical ingredients (maximum 8). In terms of the number of products used, 83.7% of all consumers reported taking one product in the preceding 12 months, with 12.3% taking two products and 4.0% using more than two products (Table 8). Generally this pattern was similar for both men and women and across the age groups, although those over 60 did report a significantly higher use of two or more products than those under 60 (19.5% vs. 15.2%) (Table 8). At country level (Table 9), some significant differences were noted: in Finland, the percentage of consumers using two or more products was significantly higher than in all other countries (40.2%). Overall 51.5% of consumers used a single-botanical product and 32.3% used one multi-botanical product (Table 8). There were no significant differences between males and females in this usage pattern, but consumers aged over 60 used less multibotanical products than those aged 18–59 (27.7% and 33.8% respectively) (Table 8). Overall, fewer consumers reported using two or more single-botanical products (4.4%) and two or more singleand multi-botanical products (11.9%) (Table 8). There were some significant differences across countries in the type of products consumed (Table 9). In the six countries, the values for single-botanical products range from 84.5% (the United Kingdom) to 20.5% (Finland). Usage of multi-botanical products was reported in all countries, with the lowest proportion (7.1%) reported in the United Kingdom (Table 9). The use of two or more single-botanical products was low in all countries as was the usage of two or more singleand multi-botanical products. Finland was an exception to the latter, with 38.2% of respondents taking multiple products (Table 9). The most common dose forms used (Table 10) are capsules (38.3%) and pills/tablets/lozenges (36.8%). No significant difference was observed in relation to gender or age (Table 10). Across the six countries (Table 11), solid forms are generally most popular, although capsules were used less frequently in Romania (17.7%). Liquid forms were less common in the United Kingdom (8.2%) and Germany (9.9%), but more common in Finland (26.2%) and Italy (26.4%) (Table 11). Table 8. PlantLIBRA’s PFS consumer survey – number and type of products taken, overall distribution and by gender and age group. Total) Gender Age group (n = 2359) Male (n = 1141) Female (n = 1218) 18–59 years (n = 1764) $ $ 60 years (n = 595) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) Number of products taken 1 product 1975 83.7 (82.2–85.2) 980 85.9 (83.9–87.9) 995 81.7 (79.5–83.9) 1496 84.8 (83.1–86.5) 479 80.5 (77.3–83.7) 2 products 289 12.3 (10.9–13.6) 123 10.8 (9.0–12.6) 166 13.6 (11.7–15.6) 196 11.1 (9.6–12.6) 93 15.6 (12.7–18.6) .2 products 95 4.0 (3.2–4.8) 38 3.3 (2.3–4.4) 57 4.7 (3.5–5.9) 72 4.1 (3.2–5.0) 23 3.9 (2.3–5.4) Product type 1 single-botanical 1214 51.5 (49.5–53.5) 606 53.1 (50.2–56.0) 608 49.9 (47.1–52.7) 900 51.0 (48.7–53.4) 314 52.8 (48.8–56.8) 1 multi -botanical 761 32.3 (30.4–34.2) 374 32.8 (30.1–35.5) 387 31.8 (29.2–34.4) 596 33.8 (31.6–36.0) 165 27.7 (24.1–31.3) 2 or more single-botanical 104 4.4 (3.6–5.2) 45 3.9 (2.8–5.1) 59 4.8 (3.6–6.1) 72 4.1 (3.2–5.0) 32 5.4 (3.6–7.2) 2 or more singleand multi-botanical 280 11.9 (10.6–13.2) 116 10.2 (8.4–11.9) 164 13.5 (11.6–15.4) 196 11.1 (9.6–12.6) 84 14.1 (11.3–16.9) doi:10.1371/journal.pone.0092265.t008 Usage of Plant Food Supplements by European Adults PLOS ONE | www.plosone.org 9 March 2014 | Volume 9 | Issue 3 | e92265 Botanicals used A total of 491 botanicals -used in at least one PFSwere reported across the six participating countries. An overview of all the reported botanicals -clustered by intervals of frequency of intake (number of consumers ranging from 194 to 5)- is shown in Table 12. Based on the survey results, the eleven most frequently used botanicals (numbers of consumers ranging from 194 to 100) in descending order are Ginkgo biloba (ginkgo), Oenothera biennis (evening primrose), Cynara scolymus (artichoke), Panax ginseng (ginseng), Aloe vera (aloe), Foeniculum vulgare (fennel), Valeriana officinalis (valerian), Glycine max (soybean), Melissa officinalis (lemon balm), Echinacea purpurea (echinacea) and Vaccinium myrtillus (blueberry) (Table 12). Table 13 shows the overall unweighted ranking of botanicals, 1– 40, according to the number of consumers, in decreasing order. Table 13 also shows that when unweighted overall data are stratified by gender, only slight differences between men and women become evident and only Glycine max (soybean) was used significantly more by women than by men (Table 13). When the overall top-40 botanical data are stratified by age groups, slight differences become evident. In the group of 18–59 year-olds, the most frequently used botanicals comply with the overall data just differing in the ranking, with Oenothera biennis (evening primrose) being the most frequently used botanical (Table 13). In the group of 60+year-old a stronger shift can be observed (Table 13). Although Ginkgo biloba (ginkgo) is still the most reported botanical -as in the overall rankingother botanicals are frequently used by that age group. Harpagophytum procumbens (devil’s claw), Vaccinium myrtillus (blueberry) and Allium sativum (garlic) are within the most frequently reported botanicals, whereas Glycine max (soybean), Melissa officinalis (lemon balm) and Echinacea purpurea (echinacea) do not appear in the top 10 ranking. Cross-country differences emerge when considering the overall top-40 botanicals more frequently present in PFS products in each of the individual six countries (Table 14). In the Finnish sample, products containing Glycine max (soybean) are the most frequently used, followed by those containing Echinacea angustifolia and purpurea (echinacea). German consumers reported Ginkgo biloba (ginkgo), Cynara scolymus (artichoke) and Olea europea (olive) as the most frequently used botanicals; whilst in Romania, Ginkgo biloba (ginkgo) was also the ingredient most frequently indicated, followed by Aloe vera (aloe) and Panax ginseng (ginseng). Amongst Italian consumers, Aloe vera (aloe) was the most frequently used botanical, followed by Foeniculum vulgare (fennel) and Valeriana officinalis (valerian). In Spain, PFS containing Cynara scolymus (artichoke) were the most frequently used products, followed by those containing Valeriana officinalis (valerian) and Equisetum arvense (horsetail). In the United Kingdom, Oenothera biennis (evening primrose) was by far the most frequently reported botanical ingredient, followed by Panax ginseng (ginseng) and Hypericum perforatum (St. John’s wort). In addition, there is a great variation in the ranking of consumed botanicals among countries. Discussion The present paper reports the findings from a European multicountry survey of PFS consumers: the PlantLIBRA PFS consumer survey. Data on the usage of PFS at the European level are limited, confined in the main to commercial market data [7] as opposed to consumer survey data, as evidenced in the recent review by Bishop and Lewith (2010)[4], where only 13% of population based consumption studies were in Europe. The European Food Safety Authority (EFSA) has recognised the lack of Table 9. PlantLIBRA’s PFS consumer survey – number and type of products taken, by country. Finland (n = 401) Germany (n = 398) Italy (n = 378) Romania (n = 400) Spain (n = 402) United Kingdom (n = 380) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) Number of products taken 1 product 240 59.9 (55.1–64.7) 351 88.2 (85.0–91.4) 341 90.2 (87.2–93.2) 350 87.5 (84.3–90.8) 345 85.8 (82.4–89.2) 348 91.6 (88.8–94.4) 2 products 93 23.2 (19.1–27.3) 45 11.3 (8.2–14.4) 34 9.0 (6.1–11.9) 40 10.0 (7.1–12.9) 48 11.9 (8.8–15.1) 29 7.6 (5.0–10.3) .2 products 68 17.0 (13.3–20.6) 2 0.5 (0.0–1.2) 3 0.8 (0.0–1.7) 10 2.5 (1.0–4.0) 9 2.2 (0.8–3.7) 3 0.8 (0.0–1.7) Product type 1 single-botanical 82 20.5 (16.5–24.4) 172 43.2 (38.3–48.1) 176 46.6 (41.5–51.6) 251 62.8 (58.0–67.5) 212 52.7 (47.9–57.6) 321 84.5 (80.8–88.1) 1 multi -botanical 158 39.4 (34.6–44.2) 179 45.0 (40.1–49.9) 165 43.7 (38.6–48.7) 99 24.8 (20.5–29.0) 133 33.1 (28.5–37.7) 27 7.1 (4.5–9.7) 2 or more single-botanical 8 2.0 (0.6–3.4) 12 3.0 (1.3–4.7) 13 3.4 (1.6–5.3) 20 5.0 (2.9–7.1) 26 6.5 (4.1–8.9) 25 6.6 (4.1–9.1) 2 or more singleand multi-botanical 153 38.2 (33.4–42.9) 35 8.8 (6.0–11.6) 24 6.4 (3.9–8.8) 30 7.5 (4.92–10.1) 31 7.7 (5.1–10.3) 7 1.8 (0.5–3.2) doi:10.1371/journal.pone.0092265.t009 Usage of Plant Food Supplements by European Adults PLOS ONE | www.plosone.org 10 March 2014 | Volume 9 | Issue 3 | e92265 data in the sector and has published a number of reports addressing related issues [15–16]. To our knowledge this is the first survey of consumers of PFS undertaken in Europe. In total 2359 consumers of PFS were recruited in this cross-sectional retrospective survey. Across all countries prevalence of usage is estimated at 18.8%. VargasMurga and colleagues (2011)[9] highlighted that comparable data at European level is difficult to identify when reviewing prevalence data from a selected number of European studies, evaluating PFS or CAM usage, with values ranging from 0.8% to 70%. All studies were based on nationally representative samples but the definition of use of supplements varied widely, in some cases being selfdefined by the participant and not distinguishing between PFS and HMP. The use of dietary supplements in a European population was measured in the European Prospective Investigation into Cancer and Nutrition (EPIC) study [8]. Usage was measured by completion of a standardised 24-hour dietary recall and included all dietary supplements that met the EU Directive 2002/46/EC. Results indicated significant differences in overall dietary supplement use between countries with herbs/plant-based supplements representing 8–17% of the products used across the ten countries. The prevalence rate reported here can be compared to rates from surveys conducted in the United States, where data on usage of dietary supplements, including herbal supplements, is collected more routinely. It is similar to the rate reported in the 2002 and 2007 National Health Interview Surveys (NHIS), 18.9% and 17.9% respectively [20]; higher than the rates of both the Eisenberg’s survey [21] and the Slone survey [22], with 14% and 12.1% respectively; and lower than the 2002 Health and Diet Survey (42%) [23] or the 1999 Kaiser Permanent Medical Care Program of Northern California (KPMCP), with a prevalence of 28.3% [24]. These differences in prevalence across studies may in part be due to the distinct selected population samples, survey methodologies (i.e. sampling methods, data collection techniques) or definitions of usage, as well as possible variations in health beliefs and health behaviour of the different populations of study [9], [24]. Survey respondents were recruited to set quotas for both age and gender to reflect characteristics previously reported for dietary supplement users. Age and gender are significant determinants of the consumption of dietary supplements in general and in botanical products in particular. Previous studies on the use of dietary supplements or other herbal-related use show a higher consumption among women as compared to men [1], [17], [24– 28] and a higher consumption among older adults as compared to younger adults [24], [29–32]. Table 10. PlantLIBRA’s PFS consumer survey – PFS dose forms used, per product used by a respondent, overall and by gender and age group. Dose forms Total Gender Age group (n = 2874) Male (n = 1358) Female (n = 1516) 18–59 years (n = 2131) $ $ 60 years (n = 743) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) Capsules a 1101 38.3 (36.5–40.1) 522 38.4 (35.9–41.0) 579 38.2 (35.8–40.6) 844 39.6 (37.5–41.7) 257 34.6 (31.2–38.0) Pills/tablets/lozenges 1057 36.8 (35.0–38.5) 498 36.7 (34.1–39.2) 559 36.9 (34.4–39.3) 765 35.9 (33.8–37.9) 292 39.3 (35.8–42.8) Liquid b 513 17.9 (16.5–19.3) 238 17.5 (15.5–19.6) 275 18.1 (16.2–20.1) 374 17.6 (15.9–19.2) 139 18.7 (15.9–21.5) Ampoules 104 3.6 (2.9–4.3) 53 3.9 (2.9–4.9) 51 3.4 (2.5–4.3) 75 3.5 (2.7–4.3) 29 3.9 (2.5–5.3) Other c 99 3.4 (2.8–4.1) 47 3.5 (2.5–4.4) 52 3.4 (2.5–4.4) 73 3.4 (2.7–4.2) 26 3.5 (2.2–4.8) Question asked . And in which form do you usually take it? (mark the applicable form). Possible responses: Pills/tablets/lozenges; Softgel capsules/pearls; Hard capsules; Liquid (extract/syrup/drops); Sachets/packets; Ampoules; Other (specify); Not sure. a Capsules: suftgels/pearls/hard capsules. b Liquid: extract/syrups/drups. c Other: Puwders, Sachets/Packets, Bars and ‘‘Not sure’’. doi:10.1371/journal.pone.0092265.t010 Table 11. PlantLIBRA’s PFS consumer survey – PFS dose forms, per product used by a respondent, by country. Dose forms Finland (n = 665) Germany (n = 446) Italy (n = 417) Romania (n = 464) Spain (n = 465) United Kingdom (n = 417) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) n % (95% CI) Capsules a 206 31.0 (27.5–34.5) 225 50.5 (45.8–55.1) 144 34.5 (30.0–39.1) 82 17.7 (14.2–21.2) 250 53.8 (49.2–58.3) 194 46.5 (41.7–51.3) Pills/tablets/lozenges 261 39.3 (35.5–43.0) 154 34.5 (30.1–39.0) 126 30.2 (25.8–34.6) 234 50.4 (45.9–55.0) 98 21.1 (17.4–24.8) 184 44.1 (39.4–48.9) Liquid b 174 26.2 (22.8–29.5) 44 9.9 (7.1–12.6) 110 26.4 (22.1–30.6) 82 17.7 (14.2-21.2) 69 14.8 (11.6–18.1) 34 8.2 (5.5–10.8) Ampoules 0 - 0 - 13 3.1 (1.5–4.8) 47 10.1 (7.4–12.9) 44 9.5 (6.8–12.1) 0 – Other c 24 3.6 (2.2–5.0) 23 5.2 (3.1–7.2) 24 5.8 (3.5–8.0) 19 4.1 (2.3–5.9) 4 0.9 (0.1–1.7) 5 1.2 (0.2–2.2) Question asked . And in which form do you usually take it? (mark the applicable form). Possible responses: Pills/tablets/lozenges; Softgel capsules/pearls; Hard capsules; Liquid (extract/syrup/drops); Sachets/packets; Ampoules; Other (specify); Not sure. a Capsules: softgels/pearls/hard capsules. b Liquid: extract/syrups/drops. c Other: Powders, Sachets/Packets, Bars and ‘‘Not sure’’. doi:10.1371/journal.pone.0092265.t011 Usage of Plant Food Supplements by European Adults PLOS ONE | www.plosone.org 11 March 2014 | Volume 9 | Issue 3 | e92265 Table 12. PlantLIBRA’s PFS consumer survey – botanicals used by at least 5 respondents, ordered by the "n of respondents’’. Used by n$ $ 75 respondents Used by n$40-,75 respondents Used by n $20-,40 respondents Used by n$5-,20 respondents n Botanical(s) n Botanical(s) n Botanical(s) n Botanical(s) 194 Ginkgo biloba; Oenothera biennis 74 Glycyrrhiza glabra 38 Cichorium intybus; Malus pumila 19 Achillea millefolium; Arctium lappa; Centella asiatica; Punica granatum; Raphanus sativus; Pyrus communis 177 Cynara scolymus 72 Mentha piperita; Paullinia cupana 37 Curcuma longa 18 Artemisia absinthium; Pollen; Lecithin 170 Panax ginseng 71 Malpighia glabra 36 Ananas comosus 17 Betula pubescens; Spirulina spec.; Vegetable charcoal; 145 Aloe vera 70 Oenothera spec. 35 Daucus carota; Glycine spec. 16 Origanum majorana; Ruscus aculeatus;Terminalia chebula 131 Foeniculum vulgare ssp 69 Silybum marianum 34 Myristica fragrans 15 Citrus paradise; Eschscholzia californica; Medicago sativa; Picea spec.; Vaccinium oxycoccus; Inulin 128 Valeriana officinalis 66 Citrus limon; Matricaria chamomilla 33 Crataegus monogyna; Cucurbita spec.; Dianthus spec.; Monascus purpureus 14 Althaea officinalis; Cuminum cyminum; Eryngium planum; Laminaria digitata; Rhamnus purshianus; Trigonella foenum-graecum; Zea mays 103 Glycine max; Melissa officinalis 64 Urtica dioica 32 Petroselinum crispum; Vaccinium macrocarpon 13 Chelidonium majus; Dioscorea villosa; Gossypium spec.; Hyssopus officinalis; Lactuca sativa; Origanum vulgare; Orthosiphon stamineus; Piper nigrum; Theobroma cacao; Trifolium pratense; Uncaria tomentosa; Lycopene; Equisetum spec.; Valeriana spec. 102 Echinacea purpurea 63 Thymus vulgaris 31 Coriandrum sativum; Echinaca spec.; Elettaria cardamomum; Prunus domestica 12 Asparagus officinalis; Azadirachta indica; Cassia occidentalis; Eucalyptus globulus; Tagetes erecta; Mentha spec.; Smilax officinalis; Xanthium spinosum 100 Vaccinium myrtillus; 61 Salvia officinalis 30 Cymbopogon citratus; Rhodiola rosea; 11 Abies alba; Artemisia abrotanum; Cetraria islandica; Cinnamomum camphora; Ilex paraguariensis; Laurus nobilis; Nasturtium officinale; Salix alba; Tilia spec.; Fraxinus excelsior; Gentiana asclepiadea; Triticum aestivum 89 Camellia sinensis; Zingiber officinale 60 Cassia senna; Rosmarinus officinalis 29 Calendula officinalis 10 Aegle marmelos; Aquilegia spec.; Armoracia rusticana; Brassica oleracea ssp.; Cheilocostus speciosus; Kaempferia galangal; Lepidium meyenii; Pimenta dioica; Populus nigra; Potentilla aurea; Santalum spec.; Sida cordifolia; Terminalia arjuna; Thymus serpyllum; Rubus fruticosus; Carlina acaulis; Centaurium spec.; Ganoderma lucidum; Tamarix gallica; Ceratonia siliqua 88 Pimpinella anisum 59 Hypericum perforatum; Lavandula angustifolia 28 Eleutherococcus senticosus; Fucus vesiculosus; Plantago ovate; Solanum lycopersicum; Spirulina platensis; Saccharomyces cerevisiae 9Aesculus hippocastanum; Aloe ferox; Berberis aristata; Brassica oleracea var. botrytis; Capparis spinosa; Capsicum annuum var. annuum; Hieracium pilosella; Opuntia ficus-indica; Serenoa repens; Solanum nigrum; Tribulus terrestris; Melissa spec. 87 Vitis vinifera 58 Carum carvi 27 Citrus aurantium 8Allium cepa; Apium graveolens; Boswellia serrate; Coffea spec.; Euterpe oleracea; Fumaria officinalis; Griffonia simplicifolia; Illicium verum; Malva sylvestris; Prunus armeniaca; Raphanus sativus convar. Sativus; Solidago virgaurea; Tamarindus indica; Carotene; Garcinia cambogia; Soy lecithin 81 Taraxacum officinale 53 Ribes nigrum 26 Schisandra chinensis; Flavonoids; Syzygium aromaticum 7Acorus calamus; Angelica sinensis; Ascophyllum nodosum; Elymus repens; Ficus carica; Hamamelis virginiana; Phaseolus vulgaris; Prunus persica; Rheum spec.; Lutein; Capsicum annuum; Fraxinus spec.; Chamomile Eng; Violeta tricolor; 79 Echinacea angustifolia 52 Oryza sativa; 25 Angelica archangelica; Beta vulgaris ssp. vulgaris var. conditiva; Citrus sinensis; Juniperus communis; Peumus boldus 6Brassica nigra; Brassica oleracea convar. acephala; Capsicum frutescens; Carthamus tinctorius; Cordyceps sinensis; Dioscorea spec.; Drosera rotundifolia; Echinacea pallida; Emblica officinalis; Fallopia japonica; Hedera spec.; Nigella sativa; Plantago psyllium; Satureja hortensis; Tilia platyphyllos; Hibiscus rosa-sinensis; Cirsium spec.; Fragaria spec.; Viola tricolor; Lavandula spec.; Fructooligosaccharides 78 Allium sativum Passiflora incarnata; 48 Hippophae rhamnoides 23 Borago officinalis; Gentiana lutea; Helianthus annuus; Ocimum basilicum; Panicum miliaceum; Pinus spec. 5Aloe spec.; Alpinia galanga; Chamaemelum nobile; Coffea arabica; Cola acuminata; Cyamopsis tetragonoloba; Equisetum telmateia; Fagopyrum esculentum; Hibiscus sabdariffa; Pinus pinaster; Pinus sylvestris; Thymus spec.; Undaria pinnatifida; Withania somnifera; Isoflavones; Arecaceae spec.; Fallopia multiflora 77 Linum usitatissimum 46 Triticum spec. 22 Plantago lanceolata; Rhamnus frangula; Vaccinium vitis-idaea Usage of Plant Food Supplements by European Adults PLOS ONE | www.plosone.org 12 March 2014 | Volume 9 | Issue 3 | e92265 Other characteristics of dietary supplements users that have been reported previously in the literature include having higher educational attainment and socioeconomic status [24], [33–34], being less likely to smoke [10], [32], [35], being more physically active [10], [29], [32]. Bailey et al. also reported a moderate alcohol consumption (1 drink per day) among dietary supplement users as compared to nonusers. In contrast, a study by Rovira et al. in a southern European population found no differences in lifestyle factors such as physical activity, smoking, and alcohol consumption between dietary supplement users and non-users [36]. Our survey population consists exclusively of PFS consumers, but their responses to a series of questions on health-related lifestyle factors reflect some of the characteristics mentioned above. The majority of PFS consumers perceived their health status to be ‘‘very good or good’’, reflecting results reported in a number of studies on dietary supplement users [32] and CAM and dietary supplement users [24], where the answer ‘‘very good or excellent’’ has been reported for self-reported health status. The survey results indicate that most consumers reported using one PFS product in the preceding 12 months, with 12% using two products and 4% using more than two. Individual country data show that Finnish consumers use more than one product and PFS with more than one botanical component, and the opposite is observed in the United Kingdom, where about 90% of the consumers use only one PFS and the products contain mostly only one botanical. In the United States, recent studies have reported that about half of the adults report using one or more dietary supplements [32], [37]. One of these studies also found that over half of dietary supplement consumers used a single-botanical product and one third used one multi-botanical product [32]. Similar results were found in our survey across all countries i.e. smaller numbers of consumers reported using two or more singlebotanical products (4.4%) and two or more singleand multibotanical products (11.9%). A wide variety of botanicals (491) is used in PFS consumed by the respondents in this survey. Overall raw data show that the most frequently (n.100) used botanicals in descending order are Ginkgo biloba (ginkgo), Oenothera biennis (evening primrose), Cynara scolymus (artichoke), Panax ginseng (ginseng), Aloe vera, Foeniculum vulgare (fennel), Valeriana officinalis (valeriana), Glycine max (soybean), Melissa officinalis (lemon balm), Echinacea purpurea (echinacea) and Vaccinium myrtillus (blueberry). These results reflect some commercial data which reported that ginkgo followed by echinacea, garlic and ginseng were the four most commercially important botanicals in the combined markets of seventeen EC Member States. In this data, echinacea and ginkgo were part of the composition of products registered as medicines [7], [9], which were excluded from our survey. Similarly, the US Food and Drug Administration 2002 Health and Diet Survey, also a 12-month retrospective study, reported the same four herbs/botanicals/or other nonvitaminnonmineral dietary supplements being the most used by its adult population – although in the following order: echinacea, garlic, ginkgo and ginseng (the latter including tea) [23]. Schaffer et al. also reported echinacea as the most consumed botanical in the Californian 1999 KPMCP survey, followed by ginkgo [24]. Differences between countries are more evident; the top list of botanicals contained in PFS for each single country complies little with the ranking of the overall data. As mentioned earlier, data were not weighted by country population size because of the study methodology which included very similar country-sample sizes of PFS consumers only, therefore caution is needed when drawing conclusions from these results at the overall 6-country level. Overall data merely describes the collected pooled data from all 6 countries. However, if the overall ranking data were to be Table 12. Cont. Used by n$ $ 75 respondents Used by n$40-,75 respondents Used by n $20-,40 respondents Used by n$5-,20 respondents n Botanical(s) n Botanical(s) n Botanical(s) n Botanical(s) 76 Equisetum arvense 43 Rosa canina; Cinnamomum spec. 21 Carica papaya; Cinnamomum verum; Crataegus spec.; Hordeum vulgare; Polygonum aviculare; Saccharum officinarum; Spinacia oleracea 75 Harpagophytum procumbens; Olea europaea 42 Sambucus nigra 20 Algae; Avena sativa; Betula spec.; Fiilipendula ulmaria; Humulus lupulus doi:10.1371/journal.pone.0092265.t012 Usage of Plant Food Supplements by European Adults PLOS ONE | www.plosone.org 13 March 2014 | Volume 9 | Issue 3 | e92265 weighted by the population size -for example the 1–5 ranking data-, the positions of the botanicals would have been only slightly altered, with Oenothera biennis (evening primrose) being the most consumed one, followed by Cynara scolymus (artichoke) Ginkgo biloba (ginkgo), Panax ginseng (ginseng) and Aloe vera (aloe). The results of the survey highlight clear differences between countries in terms of the botanicals used by consumers as PFS. Table 13. PlantLIBRA’s PFS consumer survey – distribution of the overall top-40 botanicals’ reported consumption and the ranking of these botanicals when stratified by gender and age group. All consumers Gender Age group Botanicals Male Female 18-59 years $ $ 60 years Rank a n % (95% CI) Rank b n % (95% CI) Rank b n % (95% CI) Rank b n % (95% CI) Rank b n % (95% CI) Ginkgo biloba 1 194 8.2 (7.1–9.3) 1 107 9.4 (7.7–11.0)3 87 7.1 (5.7–8.6) 2 135 7.7 (6.4–8.9) 1 59 9.9 (7.5–12.3) Oenothera biennis 2 194 8.2 (7.1–9.3) 3 85 7.5 (5.9–8.9) 1 109 9.0 (7.4–10.5)1 145 8.2 (6.9–9.5) 2 49 8.2 (6.0–10.4) Cynara scolymus 3 173 7.3 (6.3–8.4) 5 73 6.4 (5.0–7.8) 2 100 8.2 (6.7–9.7) 4 128 7.3 (6.1–8.4) 4 45 7.6 (5.4–9.6) Panax ginseng 4 167 7.1 (6.0–8.1) 2 94 8.2 (6.6–9.8) 5 73 6.0 (4.7–7.3) 3 133 7.5 (6.3–8.7) 6 34 5.7 (3.9–7.5) Aloe vera 5 145 6.2 (5.2–7.1) 4 80 7.0 (5.5–8.5) 7 65 5.3 (4.1–6.6) 5 99 5.6 (4.5–6.7) 3 46 7.7 (5.6–9.8) Foeniculum vulgare ssp. 6 132 5.6 (4.7–6.5) 7 59 5.2 (3.9–6.4) 4 73 6.0 (4.7–7.3) 6 99 5.6 (4.5–6.7) 7 33 5.6 (3.7–7.3) Valeriana officinalis 7 125 5.3 (4.4–6.2) 6 62 5.4 (4.1–6.7) 8 63 5.2 (3.9–6.4) 7 97 5.5 (4.4–6.5) 9 28 4.7 (3.0–6.4 Glycine max 8 103 4.4 (3.5–5.2) 24 34 3.0 (2.0–3.9) 6 69 5.7 (4.4–6.9) 10 81 4.6 (3.6–5.5) 14 22 3.7 (2.2–5.2) Melissa officinalis 9 103 4.4 (3.5–5.2) 8 53 4.7 (3.4–5.8) 10 50 4.1 (3.0–5.2) 9 82 4.7 (3.7–5.6) 17 21 3.5 (2.1–5.0) Echinacea purpurea 10 102 4.3 (3.5–5.1) 12 43 3.8 (2.7–4.8) 9 59 4.8 (3.6–6.0) 8 83 4.7 (3.7–5.7) 21 19 3.2 (1.8–4.6) Vaccinium myrtillus 11 100 4.2 (3.4–5.1) 9 53 4.7 (3.4–5.8) 13 47 3.9 (2.8–4.9) 12 71 4.0 (3.1–4.9) 8 29 4.9 (3.1–6.6) Pimpinella anisum 12 89 3.8 (3.0–4.5) 11 47 4.1 (3.0–5.2) 21 42 3.5 (2.4–4.4) 16 65 3.7 (2.8–4.5) 11 24 4.0 (2.5–5.6) Zingiber officinale 13 89 3.8 (3.0–4.5) 10 53 4.7 (3.4–5.8) 29 36 3.0 (2.0–3.9) 15 66 3.7 (2.9–4.6) 13 23 3.9 (2.3–5.4) Camellia sinensis 14 87 3.7 (2.9–4.5) 17 39 3.4 (2.4–4.4) 11 48 3.9 (2.9–5.0) 11 72 4.1 (3.2–5.0) 33 15 2.5 (1.3–3.7) Vitis vinifera 15 87 3.7 (2.9–4.5) 16 41 3.6 (2.5–4.6) 15 46 3.8 (2.7–4.8) 13 71 4.0 (3.1–4.9) 32 16 2.7 (1.4–4.0) Taraxacum officinale 16 80 3.4 (2.7–4.1) 21 36 3.2 (2.1–4.1) 17 44 3.6 (2.6–4.6) 17 65 3.7 (2.8–4.5) 34 15 2.5 (1.3–3.7) Echinacea angustifolia 17 79 3.4 (2.6–4.1) 23 34 3.0 (2.0–3.9) 16 45 3.7 (2.6–4.7) 20 60 3.4 (2.6–4.2) 20 19 3.2 (1.8–4.6) Passiflora incarnata 18 78 3.3 (2.6–4.0) 30 30 2.6 (1.7–3.5) 12 48 3.9 (2.9–5.0) 19 61 3.5 (2.6–4.3) 30 17 2.9 (1.5–4.2) Linum usitatissimum 19 77 3.3 (2.6–4.0) 13 43 3.8 (2.7–4.8) 33 34 2.8 (1.9–3.7) 22 56 3.2 (2.4–4.0) 16 21 3.5 (2.1–5.0) Equisetum arvense 20 76 3.2 (2.5–3.9) 19 37 3.2 (2.2–4.2) 23 39 3.2 (2.2–4.2) 23 55 3.1 (2.3–3.9) 15 21 3.5 (2.1–5.0) Allium sativum 21 75 3.2 (2.5–3.9) 28 32 2.8 (1.9–3.7) 18 43 3.5 (2.5–4.5) 29 50 2.8 (2.1–3.6) 10 25 4.2 (2.6–5.8) Harpagophytum procumbens 22 75 3.2 (2.5–3.9) 18 39 3.4 (2.4–4.4) 26 36 3.0 (2.0–3.9) 40 40 2.3 (1.6–2.9) 5 35 5.9 (4.0–7.7) Olea europaea 23 75 3.2 (2.5–3.9) 27 33 2.9 (1.9–3.8) 20 42 3.5 (2.4–4.4) 24 55 3.1 (2.3–3.9) 19 20 3.4 (1.9–4.8) Glycyrrhiza glabra 24 74 3.1 (2.4–3.8) 26 33 2.9 (1.9–3.8) 22 41 3.4 (2.4–4.4) 25 54 3.1 (2.3–3.8) 18 20 3.4 (1.9–4.8) Mentha piperita 25 72 3.1 (2.4–3.8) 20 36 3.2 (2.1–4.1) 27 36 3.0 (2.0–3.9) 27 53 3.0 (2.2–3.8) 22 19 3.2 (1.8–4.6) Paullinia cupana 26 72 3.1 (2.4–3.8) 14 43 3.8 (2.7–4.8) 38 29 2.4 (1.5–3.2) 14 66 3.7 (2.9–4.6) 74 6 1.0 (0.2–1.8) Malpighia glabra 27 71 3.0 (2.3–3.7) 15 41 3.6 (2.5–4.6) 37 30 2.5 (1.6–3.3) 18 61 3.5 (2.6–4.3) 51 10 1.7 (0.7–2.7) Oenothera spec 28 70 3.0 (2.3–3.7) 41 23 2.0 (1.2–2.8) 14 47 3.9 (2.8–4.9) 21 59 3.3 (2.5–4.2) 47 11 1.9 (0.8–2.9) Silybum marianum 29 69 2.9 (2.2–3.6) 25 34 3.0 (2.0–3.9) 30 35 2.9 (1.9–3.8) 32 46 2.6 (1.9–3.3) 12 23 3.9 (2.3–5.4) Matricaria chamomilla 30 67 2.8 (2.2–3.5) 34 29 2.5 (1.6–3.4) 25 38 3.1 (2.1–4.1) 26 54 3.1 (2.3–3.8) 38 13 2.2 (1.0–3.3) Citrus limon 31 66 2.8 (2.1–3.5) 37 24 2.1 (1.3–2.9) 19 42 3.5 (2.4–4.4) 30 48 2.7 (2.0–3.5) 25 18 3.0 (1.7–4.4) Urtica dioica 32 64 2.7 (2.1–3.4) 31 30 2.6 (1.7–3.5) 34 34 2.8 (1.9–3.7) 28 51 2.9 (2.1–3.7) 37 13 2.2 (1.0–3.3) Thymus vulgaris 33 63 2.7 (2.0–3.3) 36 28 2.5 (1.6–3.3) 31 35 2.9 (1.9–3.8) 33 44 2.5 (1.8–3.2) 24 19 3.2 (1.8–4.6) Salvia officinalis 34 61 2.6 (2.0–3.2) 32 22 1.9 (1.1–2.7) 35 39 3.2 (2.2–4.2) 34 43 2.4 (1.7–3.1) 29 18 3.0 (1.7–4.4) Cassia senna 35 60 2.5 (1.9–3.2) 43 29 2.5 (1.6–3.4) 24 31 2.6 (1.7–3.4) 37 43 2.4 (1.7–3.1) 28 17 2.9 (1.5–4.2) Rosmarinus officinalis 36 60 2.5 (1.9–3.2) 38 24 2.1 (1.3–2.9) 28 36 3.0 (2.0–3.9) 39 41 2.3 (1.6–3.0) 23 19 3.2 (1.8–4.6) Carum carvi 37 59 2.5 (1.9–3.1) 22 35 3.1 (2.1–4.0) 43 24 2.0 (1.2–2.7) 31 46 2.6 (1.9–3.3) 36 13 2.2 (1.0–3.3) Hypericum perforatum 38 59 2.5 (1.9–3.1) 29 31 2.7 (1.8–3.6) 39 28 2.3 (1.5–3.1) 35 43 2.4 (1.7–3.1) 31 16 2.7 (1.4–4.0) Lavandula angustifolia 39 57 2.4 (1.8–3.0) 40 23 2.0 (1.2–2.8) 32 34 2.8 (1.9–3.7) 36 43 2.4 (1.7–3.1) 35 14 2.4 (1.1–3.5) Ribes nigrum 40 53 2.3 (1.7–2.8) 42 22 1.9 (1.1–2.7) 36 31 2.6 (1.7–3.4) 38 41 2.3 (1.6–3.0) 41 12 2.0 (0.9–3.1) a Products ordered according to the consumer distribution of the overall top-40 used botanicals (unweighted ranking). b Ranks show the shifts of the botanicals in the position of the overall 1–40 unweighted ranking when stratified by gender and age group. doi:10.1371/journal.pone.0092265.t013 Usage of Plant Food Supplements by European Adults PLOS ONE | www.plosone.org 14 March 2014 | Volume 9 | Issue 3 | e92265 Table 14. PlantLIBRA’s PFS consumer survey – ranking of the overall top-40 botanicals’ reported consumption when stratified by country. Botanicals Finland Germany Italy Romania Spain United Kingdom Rank a n % (95% CI) Rank a n % (95% CI) Rank a n % (95% CI) Rank a n % (95% CI) Rank 1 n % (95% CI) Rank a n % (95% CI) Ginkgo biloba 0 - 1 50 12.6 (9.3–15.8) 12 17 4.5 (2.4–6.6) 1 105 26.3 (21.9–30.6) 27 11 2.7 (1.1–4.3) 11 11 2.9 (1.2–4.6) Oenothera biennis 0 - 22 15 3.8 (1.9–5.6) 174 1 0.3 (0.0–0.8) 164 1 0.3 (0.0–0.7) 20 13 3.2 (1.5–5.0) 1 164 43.2 (38.2–48.1) Cynara scolymus 53 12 3.0 (1.3–4.7) 2 47 11.8 (8.6–15.0) 10 20 5.3 (3.0–7.6) 7 27 6.8 (4.3–9.2) 1 67 16.7 (13.0–20.3) 0 – Panax ginseng 42 16 4.0 (2.1–5.9) 7 26 6.5 (4.1–9.0) 4 28 7.4 (4.8–10.1) 3 41 10.3 (7.3–13.2) 16 15 3.7 (1.9-5.6) 2 41 10.8 (7.7–13.9) Aloe vera 172 1 0.3 (0.0–0.7) 25 12 3.0 (1.3–4.7) 1 44 11.6 (8.4–14.9) 2 47 11.8 (8.6–14.9) 37 8 2.0 (0.6–3.4) 4 33 8.7 (5.9–11.5) Foeniculum vulgare ssp. 31 21 5.2 (3.1–7.4) 11 20 5.0 (2.9–7.2) 2 29 7.7 (5.0–10.4) 8 27 6.8 (4.3–9.2) 4 34 8.5 (5.7–11.2) 33 1 0.3 (0.0–0.8) Valeriana officinalis 192 1 0.3 (0.0–0.7) 19 16 4.0 (2.1–6.0) 3 29 7.7 (5.0–10.4) 43 11 2.8 (1.2–4.4) 2 51 12.7 (9.4–15.9) 6 17 4.5 (2.4–6.6) Glycine max 1 73 18.2 (14.4–22.0) 6 27 6.8 (4.3–9.3) 161 1 0.3 (0.0–0.8) 0 - 114 2 0.5 (0.0–1.2) 0 - Melissa officinalis 14 39 9.7 (6.8–12.6) 12 20 5.0 (2.9–7.2) 7 25 6.6 (4.1–9.1) 74 5 1.3 (0.2–2.3) 18 14 3.5 (1.7–5.3) 0 - Echinacea purpurea 3 55 13.7 (10.3–17.1) 0 - 59 5 1.3 (0.2–2.5) 13 24 6.0 (3.7–8.3) 70 4 1.0 (0.0–2.0) 7 14 3.7 (1.8–5.6) Vaccinium myrtillus 23 30 7.5 (4.9–10.1) 30 12 3.0 (1.3–4.7) 5 28 7.4 (4.8–10.1) 15 20 5.0 (2.9–7.1) 43 8 2.0 (0.6–3.4) 26 2 0.5 (0.0–1.3) Pimpinella anisum 16 36 9.0 (6.2–11.8) 28 12 3.0 (1.3–4.7) 38 8 2.1 (0.7–3.6) 21 15 3.8 (1.9–5.6) 11 18 4.5 (2.5–6.5) 0 – Zingiber officinale 13 41 10.2 (7.3–13.2) 36 11 2.8 (1.2–4.4) 67 5 1.3 (0.2–2.5) 4 30 7.5 (4.9–10.1) 131 2 0.5 (0.0–1.2) 0 – Camellia sinensis 28 23 5.7 (3.5–8.0) 16 16 4.0 (2.1–6.0) 22 12 3.2 (1.4–4.9) 47 10 2.5 (1.0–4.0) 6 26 6.5 (4.1–8.9) 0 – Vitis vinifera 34 20 5.0 (2.9–7.1) 5 28 7.0 (4.5–9.6) 28 11 2.9 (1.2–4.6) 127 2 0.5 (0.0–1.2) 12 18 4.5 (2.5–6.5) 13 8 2.1 (0.7–3.6) Taraxacum officinale 65 10 2.5 (1.0–4.0) 52 10 2.5 (1.0–4.1) 9 21 5.6 (3.2–7.9) 24 15 3.8 (1.9–5.6) 8 24 6.0 (3.7–8.3) 0 – Echinacea angustifolia 2 55 13.7 (10.3–17.1) 0 –48 6 1.6 (0.3–2.9) 117 2 0.5 (0.0–1.2) 31 10 2.5 (1.0–4.0) 15 6 1.6 (0.3–2.8) Passiflora incarnata 75 8 2.0 (0.6–3.4) 62 7 1.8 (0.5–3.1) 6 26 6.9 (4.3–9.4) 65 7 1.8 (0.5–3.0) 5 30 7.5 (4.9–10.0) 0 – Linum usitatissimum 24 28 7.0 (4.5–9.5) 27 12 3.0 (1.3–)4.7 95 3 0.8 (0.0–1.7) 14 24 6.0 (3.7–8.3) 73 4 1.0 (0.0–2.0) 16 6 1.6 (0.3–2.8) Equisetum arvense 26 26 6.5 (4.1–8.9) 153 1 0.3 (0.0–0.7) 60 5 1.3 (0.2–2.5) 82 4 1.0 (0.0–2.0) 3 40 10.0 (7.0–12.9) 0 – Allium sativum 27 25 6.2 (3.9–8.6) 92 3 0.8 (0.0–1.6) 69 4 1.1 (0.0–2.1) 64 7 1.8 (0.5–3.0) 7 24 6.0 (3.7–8.3) 10 12 3.2 (1.4–4.9) Harpagophytum procumbens 0 – 9 21 5.3 (3.1–7.5) 20 13 3.4 (1.6–5.3) 55 9 2.3 (0.8–3.7) 40 8 2.0 (0.6–3.4) 5 24 6.3 (3.9–8.8) Olea europaea 30 22 5.5 (3.3–7.7) 3 40 10.1 (7.1–13.0) 0 – 84 4 1.0 (0.0–2.0) 42 8 2.0 (0.6–3.4) 36 1 0.3 (0.0–0.8) Glycyrrhiza glabra 47 14 3.5 (1.7–5.3) 18 16 4.0 (2.1–6.0) 17 14 3.7 (1.8–5.6) 10 26 6.5 (4.1–8.9) 71 4 1.0 (0.0–2.0) 0 – Mentha piperita 4 47 11.7 (8.6–14.9) 24 14 3.5 (1.7–5.3) 78 4 1.1 (0.0–2.1) 75 5 1.3 (0.2–2.3) 119 2 0.5 (0.0–1.2) 0 – Paullinia cupana 130 4 1.0 (0.0–2.0) 10 21 5.3 (3.1–7.5) 8 23 6.1 (3.7–8.5) 76 5 1.3 (0.2–2.3) 14 16 4.0 (2.1–5.9) 21 3 0.8 (0.0–1.7) Malpighia glabra 12 41 10.2 (7.3–13.2) 21 15 3.8 (1.9–5.6) 18 14 3.7 (1.8–5.6) 0 – 169 1 0.3 (0.0–0.7) 0 – Oenothera spec 10 43 10.7 (7.7–13.8) 0 – 0 – 0 – 10 20 5.0 (2.9–7.1) 14 7 1.8 (0.5–3.2) Silybum marianum 190 1 0.3 (0.0–0.7) 35 11 2.8 (1.2–4.4) 15 15 4.0 (2.0–5.9) 23 15 3.8 (1.9–5.6) 19 14 3.5 (1.7–5.3) 9 13 3.4 (1.6–5.3) Matricaria chamomilla 66 10 2.5 (1.0–4.0) 38 11 2.8 (1.2–4.4) 35 9 2.4 (0.8–3.9) 20 16 4.0 (2.1–5.9) 9 21 5.2 (3.1–7.4) 0 – Citrus limon 7 43 10.7 (7.7–13.8) 112 2 0.5 (0.0–1.2) 29 10 2.7 (1.0–4.3) 146 1 0.3 (0.0–0.7) 30 10 2.5 (1.0–4.0) 0 – Urtica dioica 9 43 10.7 (7.7–13.8) 53 10 2.5 (1.0–4.1) 133 2 0.5 (0.0–1.3) 89 4 1.0 (0.0–2.0) 66 5 1.2 (0.2–2.3) 0 – Thymus vulgaris 6 47 11.7 (8.6–14.9) 177 1 0.3 (0.0–0.7) 66 5 1.3 (0.2–2.5) 87 4 1.0 (0.0–2.0) 53 6 1.5 (0.3–2.7) 0 – Salvia officinalis 8 43 10.7 (7.7–13.8) 80 5 1.3 (0.2–2.4) 82 4 1.1 (0.0–2.1) 66 7 1.8 (0.5–3.0) 124 2 0.5 (0.0–1.2) 0 – Usage of Plant Food Supplements by European Adults PLOS ONE | www.plosone.org 15 March 2014 | Volume 9 | Issue 3 | e92265  [Document text truncated for crawler view.]