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ARS Home » Southeast Area » Little Rock, Arkansas » Microbiome and Metabolism Research Unit » Research » Publications at this Location » Publication #255649
Title: Guidance from an NIH workshop on designing,implementing, and reporting clinical studies of soy interventions

Author
item KLEIN, MARGUERITE - National Institutes Of Health (NIH)
item NAHIN, RICHARD - National Institute Of Health (INSA)
item MESSINA, MARK - Loma Linda University
item RADER, JEANNE - Us Food & Drug Administration (FDA)
item THOMPSON, LILIAN - University Of Toronto
item Badger, Thomas
item DWYER, JOHANNA - National Institutes Of Health (NIH)
item KIM, YOUNG - National Cancer Institute (NCI, NIH)
item PONTZER, CAROL - National Institute Of Health (INSA)
item STARKE-REED, PAMELA - National Institutes Of Health (NIH)
item WEAVER, CONNIE - Purdue University

Submitted to: Journal of Nutrition
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 2/15/2010
Publication Date: 4/14/2010
Citation: Klein, M.A., Nahin, R.L., Messina, M.J., Rader, J.I., Thompson, L.U., Badger, T.M., Dwyer, J.T., Kim, Y.S., Pontzer, C.H., Starke-Reed, P.E., Weaver, C.M. 2010. Guidance from an NIH workshop on designing,implementing, and reporting clinical studies of soy interventions. Journal of Nutrition. 140(6):1192S-1204S.

Interpretive Summary: Soy foods and components of the soy bean have been shown to have many biological effects in animal and cell studies, such as reduction in breast cancer,and improved cardiovascular function. However, when similar studies were conducted in humans, the results were so variable that no sense could be made from the data. The NIH convened leading researchers to discuss the reasons for the variations and to come up with guidelines that would improve the chances of collecting quality data in future clinical studies. After reviewing the previous studies and discussing the pitfalls of research in soy and soy isoflavones, a set of guidelines was developed.

Technical Abstract: The NIH sponsored a scientific workshop, “Soy Protein/Isoflavone Research: Challenges in Designing and Evaluating Intervention Studies,” July 28–29, 2009. The workshop goal was to provide guidance for the next generation of soy protein/isoflavone human research. Session topics included population exposure to soy; the variability of the human response to soy; product composition; methods, tools, and resources available to estimate exposure and protocol adherence; and analytical methods to assess soy in foods and supplements and analytes in biologic fluids and other tissues. The intent of the workshop was to address the quality of soy studies, not the efficacy or safety of soy. Prior NIH workshops and an evidence-based review questioned the quality of data from human soy studies. If clinical studies are pursued, investigators need to ensure that the experimental designs are optimal and the studies properly executed. The workshop participants identified methodological issues that may confound study results and interpretation. Scientifically sound and useful options for dealing with these issues were discussed. The resulting guidance is presented in this document with a brief rationale. The guidance is specific to soy clinical research and does not address nonsoy-related factors that should also be considered in designing and reporting clinical studies. Investigators, journal editors, study sponsors, and protocol reviewers for a variety of purposes, including designing, may use this guidance in implementing trials, reporting results, and interpreting published epidemiological and clinical studies.