Trial record 10 of 404 for:    (complementary OR alternative) medicine AND (woman OR women OR female)

Women's Isoflavone Soy Health (WISH) Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Center for Complementary and Alternative Medicine (NCCAM).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Solae, LLC
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00118846
First received: July 7, 2005
Last updated: August 14, 2008
Last verified: August 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phytoestrogens and Progression of Atherosclerosis

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
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

Ages Eligible for Study:   30 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118846

Locations
United States, California
University of Southern California Keck School of Medicine
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Solae, LLC
Investigators
Principal Investigator: Howard N. Hodis, MD University of Southern California Keck School of Medicine
  More Information

Additional Information:
No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Howard N. Hodis, University of Southern California
ClinicalTrials.gov Identifier: NCT00118846     History of Changes
Other 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
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Women
Complementary and Alternative Medicine
CAM

Additional relevant MeSH terms:
Osteoporosis
Atherosclerosis
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Breast Neoplasms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Arterial Occlusive Diseases
Vascular Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014