Participants in a workshop sponsored by the National Institutes of Health have developed guidelines on designing and evaluating clinical research studies investigating soy, representing the first guidelines of their kind in the field of soy research. The guidelines are published in the June 2010 issue of The Journal of Nutrition.

These innovative guidelines are an important tool for increasing the consistency of study design and validity of outcomes in future clinical research on soy. NIH has supported research on soy in its many forms for a variety of outcomes.

The workshop, Soy Protein/Isoflavone Research: Challenges in Designing and Evaluating Intervention Studies, was supported by six NIH components. They include: Office of Dietary Supplements (ODS), National Center for Complementary and Alternative Medicine (NCCAM), National Cancer Institute, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute on Aging, and the NIH Division of Nutrition Research Coordination.

Past results of clinical studies on soy have been inconsistent and difficult to compare, which could be attributed to a number of factors, including varying product composition and dosing, study adherence, and sample size. The new guidelines are intended to improve the quality of future research studies of soy.

"NIH looks forward to the application of these guidelines," said Paul Coates, Ph.D., director of ODS. "We expect that variability in study results will be reduced and confidence in results will increase, thereby providing answers to users of soy products."

The soy research guidelines address:

  • The need for sound justification for studying the health effects of soy in humans
  • Approaches to understanding and ensuring product composition and integrity
  • Methods for assessing exposure to non-study soy and intervention adherence
  • Some appropriate analytical methods to test soy products
  • The importance of understanding how soy is processed and how it acts in the body
  • The role that genetic make-up may play in the health effects of soy.

"As with any clinical research, it is important to design studies so that results about the product or therapy being studied can be confirmed," said Josephine P. Briggs, M.D., director of NCCAM. "The soy research guidelines are an excellent example of NIH's proactive approach and commitment to scientific rigor."

While the guidelines are not requirements, investigators, journal editors, study sponsors, and protocol reviewers may consider these guidelines for a variety of purposes, including study design and implementation, reporting results, and interpretation of published studies.

Klein MA, Nahin RL, Messina MJ, et al. Guidance from an NIH Workshop on Designing, Implementing, and Reporting Clinical Studies of Soy Interventions. The Journal of Nutrition. 2010; 140(suppl):1192S–1204S .