Assessing the Health Effects of Bioactive Food Components, Bethesda, MD, March 24-25, 2005 banner image

Widespread consumer use and the potential role of bioactive components in foods and supplements in health promotion and disease prevention are of public health interest. The Office of Disease Prevention and Health Promotion (ODPHP), Office of Public Health and Science, Department of Health and Human Services (HHS), acting on behalf of an ad hoc Federal working group have undertaken the tasks of defining bioactive components and exploring approaches to evaluating their significance in health promotion and disease prevention. The ad hoc Federal working group includes representatives from HHS, The Department of Defense (DoD), and U.S. Department of Agriculture (USDA), and agencies within these departments, such as the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and The Food and Drug Administration (FDA).The goal of this cross-agency effort is to stimulate discussion and research.

The objective of the March 24-25, 2005 "Assessing the Health Effects of Bioactive Food Components" Conference was to identify guiding principles that can be used to assess the health effects of bioactive food components. The conference was organized into six unique sessions. The first five sessions featured topic areas with experts from academia, industry, and government. The sixth session highlighted key information/insights that surfaced during the previous sessions. Specifically, the conference reviewed:

  • Bioactive food components that deserve special attention and opportunities/challenges in characterizing their benefits when supplied as a food or supplement? In addition, identify what additional dietary, environmental, and genetic factors that must be considered when evaluating the efficacy of specific bioactive components for promoting health and associated biomarkers.
  • Approaches for categorizing and assessing the health effects of bioactive components. Identify common principles in these approaches and evaluate their suitability to categorize and assess the health effects of widely diverse bioactive food components.
  • Technologies that can be used to evaluate health and/or predict the onset and progression of disease. Discuss the appropriateness of these techniques to assessing the health effects of bioactive food components.

AGENDA
Thursday, March 24, 2005
7:30 AMRegistration and Continental Breakfast
8:30 AMWelcome: Leila G. Saldanha, PhD, RD, National Institutes of Health (NIH), U.S. Department of Health and Human Services (HHS)
Opening Remarks: Capt. Penelope Royall, PT, MSW, Deputy Assistant Secretary for Health, Office of Disease Prevention and Health Promotion (ODPHP), HHS
OPENING SESSION: Global Health Significance of Developing Approaches to Understanding the Health Effects of Dietary Components
Chair: Capt. Penelope Royall, PT, MSW, ODPHP, HHS
8:45 AMBioactive Food Components in Global Public Health
Martin Wiseman, PhD, Medical and Scientific Advisor, World Cancer Research Fund International, University of Southampton
   Bioactive Food Components in Global Public Health (PDF, 226kB)
9:25 AMEstimating the Economic Contribution of Dietary Components in Managing Health Costs
Patricia M. Danzon, PhD, Celia Moh Professor, The Wharton School, University of Pennsylvania
   Estimating the Economic Contribution of Dietary Components in Managing Health Costs (PDF, 227kB)
10:00 AMBREAK
SESSION ONE: Approaches for Assessing the Health Effects of Bioactive Components and the Suitability of These Approaches to Assessing the Health Effects of Dietary Bioactive Food Components
Chair: Barbara O. Schneeman, PhD, Director of Nutritional Products, Labeling, and Supplements, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA)
     Approaches for Evaluating Claims (PDF, 526kB)
10:30 AMExisting Approaches for Evaluating the Health Effects of "Essential Nutrients"
John W. Erdman, Jr., PhD, Professor of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign
   Approaches for Evaluating Health Effects of Essential Nutrients (PDF, 2111kB)
10:50 AMExisting Approaches for Evaluating the Health Effects of "Functional Foods"
Gerhard Rechkemmer, PhD, Chairman and Professor of Biofunctionality of Food, Department of Food and Nutrition, Life and Food Science Centre, Weihenstephan, Technical University of Munich
   Approaches for Evaluating Health Effects of Functional Foods (PDF, 879kB)
11:10 AMExisting Approaches for Evaluating the Health Effects of Botanicals and Natural Products
Freddie Ann Hoffman, MD, HeteroGeneity, LLC
   Approaches for Evaluating Health Effects of Natural Products (PDF, 518kB)
11:30 AMOpen Discussion
Discussant: Andrew Young, PhD,
US Army Research Institute of Environmental Medicine, U.S. Department of Defense (DoD)
 Topics for discussion:
  1. Should other approaches for evaluating the health effects of bioactive components in foods and supplements be considered?
  2. What are some common principles in these approaches and are these principles suitable to categorize and assess the health effects of bioactive food components?
  3. Do we need one approach or several approaches?
    • Foods, dietary patterns vs. isolated components, supplements.
    • Research, policy.
    • Evaluate potential beneficial and adverse effects.
  4. Concluding statements that can be drawn from current scientific knowledge?
  5. Recommendations for future research?
12:00 PMLUNCH on your own
SESSION TWO: Review Existing Models of Disease
Case Study: Cardiovascular Disease (CVD)

Identifying Distinguishing Characteristics of CVD Models Identify How These Characteristics Can Be Applied to the Understanding of Other Disease Conditions and How Dietary Components Modulate the Outcomes
Chair: Momtaz Wassef, PhD, Arteriosclerosis Research Group, National Heart, Lung, and Blood Institute (NHLBI), NIH
1:20 PMAnimal Models of Diet-Induced Atherosclerosis: Advantages and Limitations
Lawrence L. Rudel, PhD, Professor of Pathology and Biochemistry, Wake Forest University School of Medicine
   Animal Models of Diet-Induced Atherosclerosis (PDF, 791kB)
1:40 PMTranslating Cardiovascular Nutrition from the Laboratory to the Clinic
Ronald W. Krauss, MD, Director, Atherosclerosis Research, Children's Hospital Oakland Research Institute
   Translating Cardiovascular Nutrition from Laboratory to Clinic (PDF, 288kB)
2:00 PMKnowledge Gained from Cardiovascular Clinical Research and Public Health Models: The Role of Bioactive Food Components in Modifying Critical Elements for CVD
Penny Kris-Etherton, PhD, Distinguished Professor of Nutrition, Pennsylvania State University
   Role of Bioactive Food Components in Modifying CVD (PDF, 2529kB)
2:20 PMOpen Discussion
Discussant: Paula Trumbo, PhD,
CFSAN, FDA
   CFSAN Evaluation of Health Claims for CVD (PDF, 830kB)
 Topics for discussion:
  1. Are current animal models adequate for testing bioactive food components? How do you apply the data to human outcomes?
  2. Challenges in identifying appropriate biomarkers and surrogate end-points; lessons learned from CVD. Is knowledge or identification of biomarkers essential to understanding and documenting the health effects of bioactive food components?
  3. Is there a logical way for grouping and/or prioritizing dietary components that modulate the outcome of CVD? Can this scheme be applied to researching the effects of dietary components on other disease or health-related conditions?
  4. Concluding statements that can be drawn from current scientific knowledge?
  5. Recommendations for future research?
2:50 PMBREAK
SESSION THREE: Review Existing Models of Disease
Case Study: Cancer

Current Concepts in Understanding the Development and Progression of Cancer. How this Knowledge May Contribute to Assessing the Health Effects of Bioactive Food Components
Chair: John A. Milner, PhD, Nutritional Sciences Research Group, Division of Cancer Prevention, National Cancer Institute (NCI), National Institutes of Health (NIH)
3:10 PMGenetic Mechanisms of Carcinogenesis: Relevance to Bioactive Food Components
I. Bernard Weinstein, MD, Frode Jensen Professor of Medicine, Columbia University
   Genetic Mechanisms of Carcinogenesis (PDF, 2263kB)
3:30 PMRole of Biomarkers and Surrogate Endpoints: Limitations of Serum Concentrations as a Predictor of Response
Shrivendra Singh, PhD, Professor/Program Leader, University of Pittsburgh at Pittsburgh
   Biomarkers and Surrogate Endpoints for Predicting Cancer (PDF, 483kB)
3:50 PMRole of Bioactive Food Components in Cancer: Challenges in Interpreting Human Studies
Cheryl L. Rock, PhD, RD, Professor, Department of Family and Preventive Medicine, Cancer Prevention, and Control Program, University of California at San Diego
   Role of Bioactive Food Components in Cancer, Human Studies (PDF, 932kB)
4:10 PMOpen Discussion
Discussants: John Cardellina, PhD,
NCI, NIH; Ganesh M. Kishore, PhD, DuPont Agriculture and Nutrition
   CFSAN Evaluation of Health Claims for CVD (PDF, 830kB)
 Topics for discussion:
  1. What are some characteristics of cancer disease models and how can these characteristics be applied to our understanding of other disease conditions and dietary components that modulate the outcome of these disease conditions?
  2. Challenges in identifying appropriate biomarkers and surrogate end-points for cancer. Is knowledge or identification of biomarkers essential to understanding and documenting the health effects of bioactive food components? Are existing approaches adequate?
  3. Is there a logical way for grouping and/or prioritizing dietary components to research their impact on cancer? Can this scheme be applied to researching the effects of dietary components on other disease or health-related conditions?
  4. Concluding statements that can be drawn from current scientific knowledge?
  5. Recommendations for future research?
4:40 PMWrap-Up
Jennifer Weber, RD, MPH,
ODPHP, HHS
5:00 PMCLOSE
Friday, March 25, 2005
7:30 AMRegistration
8:00 AMWelcome: Review of Previous Day's Discussions
Paul M. Coates, PhD, Director, Office of Dietary Supplements (ODS), NIH
SESSION FOUR: Approaches to and Challenges in Identifying Bioactive Components in Foods and in Assessing Their Health Effects
Chair: David M. Klurfeld, PhD, National Program Leader, Human Nutrition, Agricultural Research Service (ARS), U.S. Department of Agriculture (USDA)
8:05 AMSummary of Comments Received in Response to the Federal Register Notice Defining Bioactive Food Components
Leila G. Saldanha, PhD, RD, ODS, NIH
   Defining Bioactive Food Components; Summary of Comments (PDF, 112kB)
8:20 AMHerb-Drug Interactions Caused by the Nuclear Receptor PXR
Stephen A. Kliewer, PhD, University of Texas Southwestern Medical Center, Dallas
   Herb-Drug Interactions Caused by PXR (PDF, 416kB)
8:40 AMChallenges in Identifying Food Components Responsible for Health Effects of Whole Foods
Elizabeth Jeffery, PhD, University of Illinois
   Challenges in Identifying Food Components Responsible for Health Effects (PDF, 776kB)
9:00 AMChallenges in Characterizing and Identifying Components in Botanicals Products
Joseph M. Betz, PhD, Director, Dietary Supplement Methods and Reference Materials Program, ODS, NIH
   Characterizing and Identifying Components in Botanicals (PDF, 1293kB)
9:20 AMOpen Discussion
Discussants: Christine A. Swanson, PhD,
Director, Dietary Supplements Research Centers Program, ODS, NIH
 Topics for discussion:
  1. Should the scientific considerations for the safety and/or efficacy of bioactive components in foods and supplements be the same or differ, and if so, how?
  2. Is it necessary to identify the bioactive/physiologically active component(s) in foods/supplements to assess their health effects?
  3. Given the thousands of potential bioactive food components, is there an efficient way to studying their health effects? What general structure or framework can we put in place to accomplish this?
  4. How do you deal with natural variation or variability in foods?
  5. How does one control for the matrix effect in studies?
  6. Concluding statements that can be drawn from current scientific knowledge?
  7. Recommendations for future research?
9:50 AMBREAK
SESSION FIVE: Overview of Emerging Approaches to Understanding the Development and Progression of Disease and to Assess the Health Effects of Bioactive Food Components
Chair: Barbara Bowman, PhD, Acting Associate Director for Science, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (CDC)
10:10 AMOverview of Systems Biology: Sources of Phenotypic Variation
Raymond L. Rodriguez, Professor, Section of Molecular and Cellular Biology, University of California at Davis
   Sources of Phenotypic Variation (PDF, 1791kB)
10:30 AMContributions of Genomics in Better Understanding the Development and Progression of Disease
Michael N. Liebman, PhD, Chief Scientific Officer, Windber Research Institute
   Role of Genomics in Understanding Disease (PDF, 508kB)
10:50 AMNutrigenomics: Providing "Early Warning" Molecular Biomarkers For Nutrient-Induced Changes to Homeostasis
Michael M�ller, PhD, Director, Innovative Cluster Nutrigenomics, Wageningen Centre for Food Sciences
   Nutrigenomics - Molecular Biomarker for Nutrient-Induced Changes (PDF, 6616kB)
11:10 AMOpen Discussion
Discussants: Peter Preusch, PhD,
National Institute of General Medical Sciences (NIGMS), NIH
 Topics for discussion:
  1. How do the complexities of systems biology and molecular techniques (genomics, proteomics, and metabolomics) affect current and future impact of these approaches for identifying potential health effects of bioactive food components?
  2. Can a general structure or framework be developed for using these approaches to assess or predict human health effects?
  3. Personalized/individualized nutrition: How feasible is this, given the current scientific knowledge.
  4. Are there unique issues for systems biology and -omics research for extrapolation from animal/experimental models to human outcomes?
  5. When do you move from sensitivity to specificity in research on molecular biomarkers? How do we know when we understand the biology well enough to select appropriate biomarkers?
  6. What conclusions can be drawn from current scientific knowledge?
  7. Recommendations for future research?
11:40 AMBREAK
SESSION SIX: Closing Session

Session Chairs Will Provide a Review of Their Sessions, Focusing on Knowledge Gained That Will Aid in Identifying Principles to Guide Development of Approaches to Categorize and Assess the Health Effects of Bioactive Food Components, Knowledge Gaps, and Areas for Further Research
Chair: Johanna Dwyer, DSc, RD, Senior Nutrition Scientist, ODS, NIH
12:00 PMBarbara O. Schneeman, PhD, CFSAN, FDA
12:05 PMMomtaz Wassef, PhD, NHLBI, NIH
12:10 PMJohn A. Milner, PhD, NCI, NIH
12:15 PMDavid M. Klurfeld, PhD, ARS, USDA
12:20 PMBarbara Bowman, PhD, CDC, HHS
12:25 PMOpen Discussion
12:55 PMClosing Remarks
Leila G. Saldanha, PhD, RD,
ODS, NIH
1:00 PMADJOURN


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