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Preface ix
Acknowledgments xi
Nutritional Genomics: Opportunities and Challenges 1
Introduction 1
What is Nutritional Genomics? 3
Methodology and Approach of this Book 6
Opportunities and Challenges for Nutrigenomics 8
Improved health 8
Personalized dietary advice 10
Improved diet 11
More development of health-enhancing food products 12
Consumer empowerment 12
Reducing health disparities 13
Health care savings 14
Challenges and a Road Map of This Book 14
References 16
The Science of Nutrigenomics and Nutrigenet1cs 19
Introduction 19
The Scientific Context 22
Nutrigenomics 24
Nutrigenetics 27
The Case of MTHFR 30
Room for Improvement 33
Study design 34
Epigenetics 35
SNPs and haplotypes 35
Dietary intake assessment 36
Biomarkers 36
Susceptibility and predictions 37
Analyticaland clinical validity 38
Clinical utility 39
Science and Technology Assessment 39
Conclusion 42
References 43
The Ethics of Nutrigenomic Tests and Information 49
Introduction 49
Ethical Principles 52
Nutrigenomics Testing in the Clinical Setting 55
Informed consent 55
Confidentiality 56
Secondary information 56
Families 57
Genetic testing of children and adolescents 59
Use of Nutrigenomics Information for Research 61
Use of Nutrigenomics Information by Private Third Parties 63
Insurance 64
Employment 69
Legal and social responses to fears of discrimination 71
Conclusion 72
References 73
Alternatives for Nutrigenomic Service Delivery 77
Introduction 77
Considerations for Nutrigenomic Service Delivery 80
Strength of the science 80
Regulatory environment 84
Human resource capacity and professional competence 84
Funding policy 85
Professional politics and culture 86
Consumers and patients 86
Four Alternative Models 87
Consumer model 87
Health practitioner model 93
Blended models 100
Public health model 103
Conclusion 106
References 107
Nutrigenomics and the Regulation of Health Claims for Foods and Drugs 111
Introduction 111
Genetic tests, service delivery, and genetic antidiscrimination 113
Food Categories: Functional Foods, Nutraceuticals, Medicinal Foods, and Dietary Supplements 115
Functional foods 117
Nutraceuticals 118
Medical or medicinal foods 118
Dietary supplements 119
Health-Related Claims Associated with Foods Compared to Drugs 119
Structure-function claims 120
Health claims 120
Medical food claims 120
Disease risk reduction claims 121
Nutrigenomic Information and the Regulation of Foods Compared to Drugs 121
The regulation of foods 122
The regulation of drugs 123
Food and Drug Regulations in Japan, the United States, and Canada 124
Japan 125
United States 126
Canada 127
Conclusion 129
References 130
Nutrigenomics: Justice, Equity, and Access 133
Introduction 133
Industrialized Country Context 135
Individualized nutrigenomic testing 135
Population-based nutrigenomics 136
Developing Country Context 137
Individualized nutrigenomic testing 137
Nutrigenomics and Intellectual Property 143
An issue of access to scientific information 146
Conclusion 147
References 148
Conclusions and Recommendations 153
Introduction 153
Nutrigenomic science 154
Nutrigenomics and health information management 155
Nutrigenomic service delivery 155
Regulation of nutrigenomics 156
Access and equity 157
A Final Word 158
Index 161
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