E9-10788. NIH-Sponsored Workshop: “Soy Protein and Isoflavones Research: Challenges in Designing and Evaluating Intervention Studies”; Notice  

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    The National Institutes of Health (NIH) Office of Dietary Supplements (ODS) is co-sponsoring a workshop entitled “Soy Protein and Isoflavones Research: Challenges in Designing and Evaluating Intervention Studies” with other NIH Institutes and Centers (National Center for Complementary and Alternative Medicine, National Cancer Institute, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute on Aging, and the Division of Nutrition Research Coordination). The workshop will be held on July 28-29 at the Bethesda North Marriott Hotel and Conference Center, Bethesda, Maryland.

    Summary

    NIH has been supporting research on soy in its many forms for a range of outcomes. Questions concerning which forms of soy might be better for studies of specific health outcomes and at what doses led the National Center for Complementary and Alternative Medicine and the Office of Dietary Supplements to commission an evidence-based review of the literature. The resulting report (http://www.ahrq.gov/​clinic/​tp/​soytp.htm) found a large, but weak, literature with equivocal findings. Moreover, the National Institute of Environmental Health Sciences provided some troubling data about soy products used in research, which included confounding produced by unanticipated levels of phytoestrogens in animal feed (Heindel et al. Environmental Health Perspectives 2008:116(3);389-393). Hence, components of the NIH became concerned about the quality of data from human studies.

    The purpose of this workshop, therefore, is to provide guidance for the next generation of soy protein and isoflavone human research. Specifically, the workshop objectives are to identify (1) methodological issues relative to exposures and interventions that may confound study results and interpretation and (2) scientifically sound and useful options and solutions for dealing with these issues in the design, conduct, reporting of results, and interpretation of ongoing and future studies. NIH is seeking input from scientists from multiple disciplines, including nutritionists, physicians, analytical chemists, epidemiologists, biochemists, and clinical trialists from academia, industry, and government. This highly participatory workshop will address issues related to population exposure to soy and other phytoestrogens, factors influencing variability of response to soy interventions and negative consequences of exposure, methods and tools to assess exposure, product composition, and analytic methods to assess soy product constituents and metabolites.

    Registration

    Seating at this workshop is very limited. To register, please e-mail by June 1, 2009, your name, complete contact information (including phone number, e-mail address, and street address), and the dates that you plan to attend to Ms. Tricia Wallich at wallich@csionweb.com . If you do not have access to e-mail, please call Ms. Wallich at 301-670-0270 (not a toll-free number). Ms. Wallich will be coordinating the registration for this workshop.

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    Dated: May 4, 2009.

    Raynard S. Kington,

    Acting Director, National Institutes of Health.

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    [FR Doc. E9-10788 Filed 5-7-09; 8:45 am]

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