Phase 2
Completed N=350
Women's Isoflavone Soy Health (WISH) Trial
Source: ClinicalTrials.gov NCT00118846 ↗Enrolled (actual)
350
Serious AEs
41.2%
Results posted
May 2023
Primary outcomePrimary: Progression of Subclinical Atherosclerosis — 4.77; 5.68 um/year — p=0.35
Summary
The purpose of this study is to determine whether soy supplementation can reduce hardening of the arteries and cognitive decline in postmenopausal women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression of Subclinical Atherosclerosis |
4.77; 5.68 | 0.35 |
| SECONDARY Change in Neurocognitive Function (Global Cognition) |
0.42; 0.31 | 0.36 |
Eligibility Criteria
Inclusion Criteria
- Postmenopausal, defined as no vaginal bleeding for at least 1 year and serum estradiol level lower than 20 pg/ml
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00118846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.