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Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) Office of Dietary Supplements (ODS) Office of Research on Women's Health (ORWH) Solae Company |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00118846 |
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 |
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Atherosclerosis Cardiovascular Diseases Heart Diseases Osteoporosis Menopause Breast Cancer Dementia |
Dietary Supplement: 25 g soy protein supplement Other: Matching placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phytoestrogens and Progression of Atherosclerosis |
Enrollment: | 350 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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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2: Placebo Comparator
Matching placebo
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Other: Matching placebo
Milk protein administered twice daily
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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 older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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: | University of Southern California ( Howard N. Hodis ) |
Study ID Numbers: | U01 AT001653, U01 AT001653-02S2, U01 AT001653-02S4, U01 AT001653-02S5 |
Study First Received: | July 7, 2005 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00118846 History of Changes |
Health Authority: | United States: Federal Government |
Women Complementary and Alternative Medicine CAM |
Atherosclerosis Arterial Occlusive Diseases Heart Diseases Skin Diseases Disease Progression Vascular Diseases Central Nervous System Diseases Breast Neoplasms Osteoporosis Bone Diseases, Metabolic Arteriosclerosis |
Brain Diseases Bone Diseases Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Musculoskeletal Diseases Mental Disorders Phytoestrogens Dementia Menopause Breast Diseases Delirium |
Atherosclerosis Arterial Occlusive Diseases Heart Diseases Skin Diseases Nervous System Diseases Vascular Diseases Central Nervous System Diseases Breast Neoplasms Osteoporosis Bone Diseases, Metabolic Arteriosclerosis |
Brain Diseases Bone Diseases Neoplasms Delirium, Dementia, Amnestic, Cognitive Disorders Neoplasms by Site Musculoskeletal Diseases Mental Disorders Cardiovascular Diseases Dementia Breast Diseases |