Women's Isoflavone Soy Health (WISH) Trial

• Sponsor: University of Southern California (Other)
• Overall Status: Completed
• CT.gov ID: NCT00118846
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH), Office of Dietary Supplements (ODS) (NIH), Office of Research on Women's Health (ORWH) (NIH), Solae, LLC (Industry)
• Enrollment: 350
• Location: 1
• Arms: 2
• Duration (Months): 60
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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 Design

• Study Type: Interventional
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Phytoestrogens and Progression of Atherosclerosis
• Study Start Date: Mar 1, 2004
• Actual Primary Completion Date: Sep 1, 2005
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. Longitudinal change in cognitive function, bone mineral density, and mammographic percent density [Cognitive function: Baseline and end-of-study; Bone mineral density: Baseline, 12 month, 30 month; Mammographic percent density: Baseline, 12 month, 24 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Howard Hodis, Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT00118846
• Other Study ID Numbers: U01AT001653; U01AT001653; U01AT001653-02S2; U01AT001653-02S4; U01AT001653-02S5
• First Posted: Jul 12, 2005
• Last Update Posted: Mar 30, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Howard Hodis, Professor, University of Southern California: Women; Complementary and Alternative Medicine; CAM
• Additional relevant MeSH terms: Osteoporosis; Cardiovascular Diseases; Heart Diseases; Atherosclerosis

Study Results

No Results Posted as of Mar 30, 2017