This trial is active, not recruiting.

Conditions atherosclerosis, cardiovascular diseases, heart diseases, osteoporosis, menopause, breast cancer, dementia
Treatments 25 g soy protein supplement, matching placebo
Phase phase 2/phase 3
Sponsor National Center for Complementary and Alternative Medicine (NCCAM)
Collaborator Office of Dietary Supplements (ODS)
Start date March 2004
End date January 2009
Trial size 350 participants
Trial identifier NCT00118846, U01 AT001653, U01 AT001653-02S2, U01 AT001653-02S4, U01 AT001653-02S5


The purpose of this study is to determine whether soy supplements can reduce hardening of the arteries in postmenopausal women. This study will also determine the effects of soy supplements on mental processes, bone mineral density, and breast tissue density.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
25 gm soy protein administered twice daily in equivalent dosages (12.5 gm)
25 g soy protein supplement
25 g soy protein admisitered in equally divided dosage twice daily
(Placebo Comparator)
Matching placebo
matching placebo
Milk protein administered twice daily

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 30 years old.

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

Additional Information

Official title Phytoestrogens and Progression of Atherosclerosis
Principal investigator Howard N. Hodis, MD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2008.
Information provided to ClinicalTrials.gov by National Center for Complementary and Alternative Medicine (NCCAM).