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Women's Isoflavone Soy Health (WISH) Trial

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.
 
ClinicalTrials.gov Identifier: NCT00118846
Recruitment Status : Completed
First Posted : July 12, 2005
Last Update Posted : March 30, 2017
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE July 7, 2005
First Posted Date  ICMJE July 12, 2005
Last Update Posted Date March 30, 2017
Study Start Date  ICMJE March 2004
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2005)
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
Change History Complete list of historical versions of study NCT00118846 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2005)
Longitudinal change in cognitive function, bone mineral density, and mammographic percent density
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Women's Isoflavone Soy Health (WISH) Trial
Official Title  ICMJE Phytoestrogens and Progression of Atherosclerosis
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Atherosclerosis
  • Cardiovascular Diseases
  • Heart Diseases
  • Osteoporosis
  • Menopause
  • Breast Cancer
  • Dementia
Intervention  ICMJE
  • Dietary Supplement: 25 g soy protein supplement
    25 g soy protein admisitered in equally divided dosage twice daily
  • Other: Matching placebo
    Milk protein administered twice daily
Study Arms  ICMJE
  • Experimental: 1
    25 gm soy protein administered twice daily in equivalent dosages (12.5 gm)
    Intervention: Dietary Supplement: 25 g soy protein supplement
  • Placebo Comparator: 2
    Matching placebo
    Intervention: Other: Matching placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2008)
350
Original Enrollment  ICMJE
 (submitted: July 7, 2005)
300
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00118846
Other Study ID Numbers  ICMJE U01AT001653( U.S. NIH Grant/Contract )
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Howard Hodis, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE
  • National Center for Complementary and Integrative Health (NCCIH)
  • Office of Dietary Supplements (ODS)
  • Office of Research on Women's Health (ORWH)
  • Solae, LLC
Investigators  ICMJE
Principal Investigator: Howard N. Hodis, MD University of Southern California Keck School of Medicine
PRS Account University of Southern California
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP