Women's Isoflavone Soy Health (WISH) Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-12

Study Completion Date

2009-03-19

Brief Summary

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The purpose of this study is to determine whether soy supplementation can reduce hardening of the arteries and cognitive decline in postmenopausal women.

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Detailed Description

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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 supplementation on subclinical atherosclerosis progression and cognitive decline in postmenopausal women.

In this double-blinded, placebo-controlled trial, a total of 350 postmenopausal women were randomly assigned to receive either soy protein supplementation or placebo twice daily for 2.7 years. The initial 2.5-year treatment period was increased to 3 years. The active product, given as two divided doses, was 25 g soy protein containing 85 mg aglycone weight naturally-occurring isoflavones (150 mg total isoflavone) of 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). The primary trial end point was the rate of change in the right distal common carotid artery intima-media thickness (CIMT) by ultrasonography. Participants underwent ultrasonography at baseline and every six months along with laboratory determinations and clinical measurements. Cognitive assessments were completed at baseline and the final follow-up visit (2.5 years).

Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Isoflavone Soy Protein (ISP) Supplementation

25 gm soy protein supplementation administered twice daily in equivalent dosages (12.5 gm)

Group Type ACTIVE_COMPARATOR

25 gm soy protein supplement

Intervention Type DIETARY_SUPPLEMENT

25 gm soy protein supplementation administered in equally divided dosage twice daily (12.5 gm)

Placebo

Milk protein matching placebo administered twice daily in equivalent dosages

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Milk protein administered twice daily

Interventions

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25 gm soy protein supplement

25 gm soy protein supplementation administered in equally divided dosage twice daily (12.5 gm)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Milk protein administered twice daily

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal, defined as no vaginal bleeding for at least 1 year and serum estradiol level lower than 20 pg/ml

Exclusion Criteria

* Signs, symptoms or personal history of cardiovascular disease
* Diabetes mellitus or fasting serum glucose of 126 mg/dL or greater
* Fasting plasma triglyceride 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, nut, or related food allergies
* More than 5 alcohol drinks per day or substance abuse

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Howard N. Hodis, M.D.

Harry J. Bauer and Dorothy Bauer Rawlins Professor of Cardiology, Professor of Medicine, Population and Public Health Sciences, and Molecular Pharmacology and Toxicology, Director, Atherosclerosis Research Unit

Responsibility Role PRINCIPAL_INVESTIGATOR