Status:
COMPLETED
Women's Isoflavone Soy Health (WISH) Trial
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Conditions:
Atherosclerosis
Eligibility:
FEMALE
30+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether soy supplementation can reduce hardening of the arteries and cognitive decline in postmenopausal women.
Detailed Description
Heart disease is the leading cause of death among women in the United States. Atherosclerosis, a primary cause of heart disease, accounts for more than 485,000 heart attacks and 370,000 strokes each y...
Eligibility Criteria
Inclusion
- Postmenopausal, defined as no vaginal bleeding for at least 1 year and serum estradiol level lower than 20 pg/ml
Exclusion
- Signs, symptoms or personal history of cardiovascular disease
- Diabetes mellitus or fasting serum glucose of 126 mg/dL or greater
- Fasting plasma triglyceride of 500 mg/dL or greater
- Serum creatinine greater than 2.0 mg/dL
- Uncontrolled hypertension
- Untreated thyroid disease
- Life expectancy less than 5 years
- Current use of hormone replacement therapy (HRT)
- Soy, nut, or related food allergies
- More than 5 alcohol drinks per day or substance abuse
Key Trial Info
Start Date :
April 12 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2009
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00118846
Start Date
April 12 2004
End Date
March 19 2009
Last Update
May 6 2023
Active Locations (1)
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1
Atherosclerosis Research Unit, University of Southern California
Los Angeles, California, United States, 90033