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Women's Isoflavone Soy Health (WISH) Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00118846
First Posted: July 12, 2005
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Office of Research on Women's Health (ORWH)
Solae, LLC
Information provided by (Responsible Party):
Howard Hodis, University of Southern California
  Purpose
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 Dietary Supplement: 25 g soy protein supplement Other: Matching placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phytoestrogens and Progression of Atherosclerosis

Resource links provided by NLM:


Further study details as provided by Howard Hodis, University of Southern California:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 350
Study Start Date: March 2004
Study Completion Date: March 2009
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
25 gm soy protein administered twice daily in equivalent dosages (12.5 gm)
Dietary Supplement: 25 g soy protein supplement
25 g soy protein admisitered in equally divided dosage twice daily
Placebo Comparator: 2
Matching placebo
Other: Matching placebo
Milk protein administered twice daily

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118846


Locations
United States, California
University of Southern California Keck School of Medicine
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Office of Research on Women's Health (ORWH)
Solae, LLC
Investigators
Principal Investigator: Howard N. Hodis, MD University of Southern California Keck School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Howard Hodis, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00118846     History of Changes
Other Study ID Numbers: U01AT001653 ( U.S. NIH Grant/Contract )
U01AT001653-02S2 ( U.S. NIH Grant/Contract )
U01AT001653-02S4 ( U.S. NIH Grant/Contract )
U01AT001653-02S5 ( U.S. NIH Grant/Contract )
First Submitted: July 7, 2005
First Posted: July 12, 2005
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by Howard Hodis, University of Southern California:
Women
Complementary and Alternative Medicine
CAM

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Dementia
Osteoporosis
Atherosclerosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases