Phase I Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women
Status:
Completed
Trial end date:
2005-07-01
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to examine the safety of specific soy components, known
as isoflavones, and to find out what effects (good and bad) these components have on tissues
that are sensitive to the hormone estrogen in healthy, post-menopausal women. Isoflavones are
compounds that occur naturally in soybeans and can be extracted to put in to capsule form or
add to foods. The capsule formulation being used in this study is considered an
investigational drug. This research is being done because many scientists believe that
isoflavones may play a role in the prevention of some kinds of cancer. While isoflavones have
been safely consumed in foods for centuries, we need to know if these soy components are safe
to take in higher doses when they are extracted from foods and provided in a supplement form.
We plan to test the safety and effects of the soy isoflavones known as genistein, daidzein
and glycitein.