Women's Isoflavone Soy Health (WISH) Trial
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| ClinicalTrials.gov Identifier: NCT00118846 |
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Recruitment Status :
Completed
First Posted : July 12, 2005
Last Update Posted : March 30, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atherosclerosis Cardiovascular Diseases Heart Diseases Osteoporosis Menopause Breast Cancer Dementia | Dietary Supplement: 25 g soy protein supplement Other: Matching placebo | Phase 2 Phase 3 |
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 year in American women. Data indicate that a woman's risk of suffering from an atherosclerosis-related cardiovascular event significantly increases after menopause; this risk may be due to reduced estrogen production associated with menopause. Soy isoflavones are plant compounds that are structurally similar to human estrogen. Evidence suggests that soy supplements may provide the same protection against heart disease as estrogen in postmenopausal women. This study will determine the effects of soy supplements on atherosclerosis progression, cognition, bone mineral density, and breast tissue density changes in postmenopausal women.
This study will last 2.5 years. Participants will be randomly assigned to receive either soy supplements or placebo daily for the duration of the study.
The active product, which will be given as two divided doses, is 25 g soy protein containing 85 mg aglycone weight naturally-occurring isoflavones (150 mg total isoflavone), genistein 45 mg aglycone weight (80 mg total weight), daidzein 35 mg aglycone weight (60 mg total weight) and glycitein 5 mg aglycone weight (10 mg total weight). Blood collection, cognitive tests, and mammograms will be used to assess participants at study entry, at each monthly visit, and at study completion.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 350 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Phytoestrogens and Progression of Atherosclerosis |
| Study Start Date : | March 2004 |
| Actual Primary Completion Date : | September 2005 |
| Actual Study Completion Date : | March 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
25 gm soy protein administered twice daily in equivalent dosages (12.5 gm)
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Dietary Supplement: 25 g soy protein supplement
25 g soy protein admisitered in equally divided dosage twice daily |
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Placebo Comparator: 2
Matching placebo
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Other: Matching placebo
Milk protein administered twice daily |
- Progression of subclinical atherosclerosis measured by the rate of change in distal common carotid artery far wall intima-media thickness in computer image processed B-mode ultrasonograms [ Time Frame: Baseline and every 6 months ]
- Longitudinal change in cognitive function, bone mineral density, and mammographic percent density [ Time Frame: Cognitive function: Baseline and end-of-study; Bone mineral density: Baseline, 12 month, 30 month; Mammographic percent density: Baseline, 12 month, 24 month ]
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| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Postmenopausal, defined as having no vaginal bleeding for at least 1 year and having a serum estradiol level higher than 20 pg/ml
Exclusion Criteria:
- Signs or history of cardiovascular disease
- Diabetes mellitus or fasting serum glucose of 140 mg/dL or greater
- Plasma triglyceride levels 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- or nut-related food allergies
- Follow a vegan diet
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118846
| United States, California | |
| University of Southern California Keck School of Medicine | |
| Los Angeles, California, United States, 90033 | |
| Principal Investigator: | Howard N. Hodis, MD | University of Southern California Keck School of Medicine |
| Responsible Party: | Howard Hodis, Professor, University of Southern California |
| ClinicalTrials.gov Identifier: | NCT00118846 |
| Other Study ID Numbers: |
U01AT001653 ( U.S. NIH Grant/Contract ) U01AT001653 ( U.S. NIH Grant/Contract ) U01AT001653-02S2 ( U.S. NIH Grant/Contract ) U01AT001653-02S4 ( U.S. NIH Grant/Contract ) U01AT001653-02S5 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 12, 2005 Key Record Dates |
| Last Update Posted: | March 30, 2017 |
| Last Verified: | March 2017 |
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Women Complementary and Alternative Medicine CAM |
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Osteoporosis Cardiovascular Diseases Heart Diseases Atherosclerosis Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Metabolic Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |