[Federal Register Volume 74, Number 88 (Friday, May 8, 2009)]
[Page 21698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10788]



National Institutes of Health

NIH-Sponsored Workshop: ``Soy Protein and Isoflavones Research: 
Challenges in Designing and Evaluating Intervention Studies''; Notice

    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, 


    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.


    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 
[email protected] . 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.

    Dated: May 4, 2009.
Raynard S. Kington,
Acting Director, National Institutes of Health.
[FR Doc. E9-10788 Filed 5-7-09; 8:45 am]