Phytoestrogens and Progression of Atherosclerosis
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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
Baseline and every 6 months
Howard N. Hodis, MD
University of Southern California Keck School of Medicine
United States: Federal Government
|University of Southern California Keck School of Medicine||Los Angeles, California 90033|