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.

Condition	Intervention	Phase
Atherosclerosis Cardiovascular Diseases Heart Diseases Osteoporosis Menopause Breast Cancer Dementia	Drug: Soy protein supplement	Phase II Phase III

Further Study Details: 

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
Secondary Outcomes: Longitudinal change in cognitive function, bone mineral density, and mammographic percent density
Expected Total Enrollment:  300

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.

Ages Eligible for Study:  30 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00118846

WISH Staff      323-442-3658 

California
      University of Southern California Keck School of Medicine, Los Angeles,  California,  90033,  United States; Recruiting

Study chairs or principal investigators

Howard N. Hodis, MD,  Principal Investigator,  University of Southern California Keck School of Medicine   

Study ID Numbers:  U01AT001653; U01AT001653-02S2; U01AT001653-02S4; U01AT001653-02S5
Record last reviewed:  July 2005
Last Updated:  July 18, 2005
Record first received:  July 11, 2005
ClinicalTrials.gov Identifier:  NCT00118846
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26