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Phase I Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women

NCT00491595 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2007-06-26

No results posted yet for this study

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.

Conditions

  • Drug Toxicity

Interventions

DRUG

High Dose Soy isoflavones

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of North Carolina

    lead OTHER

Principal Investigators

  • Steven H Zeisel, MD, PhD · UNC at Chapel Hill

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-03-31
Completion
2005-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00491595 on ClinicalTrials.gov