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Phytoestrogens and Health (2003) COT Report – Phytoestrogens and Health (2003)COT Report – Phytoestrogens FSA Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment Phytoestrogens and Health © Crown copyright 2003 Glycine max Published by the Food Standards Agency May 2003 FSA/0826/0503 May 2003 © Crown Copyright This material may be reproduced without formal permission or charge for personal or in-house use. First Published: 2003 Further copies may be obtained from: The Food Standards Agency Aviation House 125 Kingsway Holborn London WC2B 6NH This document is also available on the Food Standards Agency internet web site at: http://www.food.gov.uk/science/ouradvisors/toxicity/COTwg/wg_phyto/ Front cover illustration: Courtesy of Miss V Hastings-Cook. Committee on TOXICITY Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment Phytoestrogens and Health Chairman Professor I Hughes Chairman of the Working Group on Phytoestrogens and Health: Professor HF Woods © Crown Copyright Contents Page Chapter 1 Executive summary 5 Chapter 2 Introduction 17 Historical background 17 Terms of reference 19 Membership of the Working Group 20 Methods of working 20 Chapter 3 Chemistry and analysis of phytoestrogens 23 Chemical structures and nomenclature 23 Analysis of phytoestrogens 33 Key points 37 Chapter 4 Sources and concentrations of phytoestrogens in foods and estimated dietary intake 45 Sources of phytoestrogens in food 45 Variability of phytoestrogen concentration in plants 46 Concentrations of phytoestrogens in foods 48 Concentrations of isoflavones in infant foods 52 Phytoestrogen intakes from the UK diet 53 Phytoestrogen intake in other countries 57 Key points 61 Chapter 5 Absorption, distribution, metabolism and excretion of phytoestrogens 69 Introduction 69 Absorption 69 Metabolism 71 Distribution 76 Pharmacokinetics 77 Excretion 82 Inter-individual variation in ADME 85 Bioavailability and metabolism of phytoestrogens in the new-born and infants 90 Key points 93 Chapter 6 Cellular and molecular mechanisms of oestrogen action 103 Introduction 103 Receptor mediated mechanisms 103 Oestrogen receptor subtypes 107 Binding of phytoestrogens to oestrogen receptors 113 Ligand-independent activation of oestrogen receptors 116 Cell surface oestrogen receptors 116 Oestrogen receptor and aromatase knockout mice 117 Key points 120 Chapter 7 Additional effects mediated by phytoestrogens 129 Introduction 129 Effects on oestrogen bioavailability 129 Effects on oestrogen biosynthesis and metabolism 131 Other biochemical effects of phytoestrogens 137 Key points 143 1 Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment Chapter 8 Estimation of phytoestrogen oestrogenic potency 153 Introduction 153 Oestrogen receptor binding assays 153 Cell proliferation assays 155 Recombinant mammalian and yeast cell-based transcription assays 157 Interpretation of in vitro potency data 158 In vivo assessment of oestrogenic effects 159 Phytoestrogen potency determined by in vitro and in vivo methods 162 Key points 165 Chapter 9 Effects of phytoestrogens on fertility and development 173 Introduction 173 Role of hormones in human sexual differentiation 174 Hormones and ‘endocrine disruption’: critical windows of vulnerability 177 Effects of phytoestrogens on non-reproductive tissues 178 In vivo studies of the effects of phytoestrogens on sexual development and reproduction 185 Studies on the effects of phytoestrogens in rodents 185 Studies on the effects of phytoestrogens in primates 205 Studies on the effects of phytoestrogens in humans 208 Interpretation of data in relation to human exposure 209 Key points 210 Chapter 10 Effect of phytoestrogens on the thyroid gland and thyroid function 221 Introduction 221 Soy and isoflavones: effects on the thyroid 223 Possible mechanisms of isoflavones-thyroid interactions 227 Potential thyroid-phytoestrogen interactions 228 Key points 232 Chapter 11 Phytoestrogens and the central nervous and immune systems 237 Effects of phytoestrogens on the central nervous system 237 Key points 244 Phytoestrogens and immune function 245 Key points 248 Chapter 12 Phytoestrogens and osteoporosis 253 Introduction 253 Animal studies 253 Human studies 255 Intervention studies 260 Key points 262 Chapter 13 Phytoestrogens and the cardiovascular system 267 Introduction 267 Lipid profiles 269 Blood pressure 278 Thrombosis 280 Atherosclerosis 280 US Food and Drug Administration consideration of soy and CHD 282 Key points 282 2 Chapter 14 Phytoestrogen modulation of endogenous hormones in humans 293 Introduction 293 Hormonal effects in peri- and postmenopausal women 293 Hormonal effects in premenopausal women 300 Hormonal effects in men 302 Effects of phytoestrogens on diabetes 303 Key points 304 Chapter 15 Phytoestrogens and cancer 311 Introduction 311 Breast cancer 311 Epidemiological studies 312 Key points 324 Female reproductive tract cancers 325 Key points 326 Prostate cancer 327 Key points 331 Colorectal cancer 331 Key points 333 Stomach cancer 334 Key points 335 Lung cancer 336 Key points 338 Main summary 338 Chapter 16 International policy on soy-based infant formula 357 Chapter 17 Summary 361 Chapter 18 Conclusions 371 Recommendations for future research 378 Appendices Appendix 1 Glossary of terms and abbreviations 379 Appendix 2 Submissions to the Working Group421 Appendix 3 Literature searches conducted and search terms used 429 Appendix 4 List of those who made presentations to the Working Group 431 Appendix 5 Membership of the Working Group on Phytoestrogens 433 Appendix 6 Declared interests of the Working Group on Phytoestrogens 435 Appendix 7 Membership of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment 437 Appendix 8 Details of the Food Standards Agency research projects on phytoestrogens 439 3 1. Executive summary 1.1 This report of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) considers the public health implications of exposure to phytoestrogens in the diet. The report was drafted by a specially convened Working Group of the Committee with the following terms of reference: “To advise on the health implications of dietary phytoestrogens through review of published scientific research and the Food Standards Agency’s phytoestrogen research programme.” 1.2 In order to address these terms of reference, the Working Group considered the following key points: • On the basis of current evidence, does ingestion of soy-based infant formula pose any risk for human infants? • Are there health implications for other sub-groups of the population from the ingestion of dietary phytoestrogens? • To consider the evidence for beneficial effects of dietary phytoestrogens. • To make recommendations for further research. Structure of the report 1.3 The Working Group held a total of five meetings between April 2000 and March 2001. The Working Group considered peer reviewed published reports published up to 30 April 20021. Preliminary research reported in the form of meeting abstracts was not included unless the work was published in full, in a peer reviewed scientific journal by 30 April 2002. The Working Group acknowledged that anecdotal reports and reviews had been published expressing opinions on the health implications of phytoestrogens. The Group considered these reports but concluded that such information could not be considered as objective or definitive evidence of adverse or beneficial effects of phytoestrogens. Therefore, the Group, where appropriate, noted such opinions but agreed it would not base any conclusions on the health implications of dietary phytoestrogens from this evidence. 1.4 A draft report was prepared by the Secretariat and Members of the Working Group and the report discussed at a series of four drafting group meetings from March 2001 to May 2002. The draft report was submitted to the COT for consideration in two parts at meetings held in February and July 2002. Some modifications were made in light of Members’ comments. 1.5 The report was issued for public consultation from October to December 2002. In addition, the Scientific Advisory Committee on Nutrition considered the evidence and conclusions presented in the report relating to soy-based infant formula and provided an opinion. 1 Unpublished data from the FSA phytoestrogen research programme as well as studies received in press, which were considered by the Working Group prior to April 2002 and subsequently published have been included in the report. 5 Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment 1.6 The Working Group considered the consultation submissions in January 2003 and further modifications were made to the report. Additional studies published after the literature cut-off date of 30 April 2002 were identified in some submissions. These were considered by the Working Group and included in the redrafted report only if they substantially altered key issues or conclusions. The draft report was submitted to the COT for consideration and endorsement at a meeting held in February 2003. Details of the background to the Working Group and its methods of working are given in Chapter 2 of the report. 1.7 For the purposes of this report, the Working Group agreed a definition of a phytoestrogen as: any plant substance or metabolite that induces biological responses in vertebrates and can mimic or modulate the actions of endogenous oestrogens usually by binding to oestrogen receptors. Chapter 3 describes the
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