Women's Isoflavone Soy Health (WISH) Trial

Atherosclerosis Clinical Trial

Official title:

Phytoestrogens and Progression of Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118846
• Other study ID #: U01AT001653
• Secondary ID: U01AT001653U01AT
• Status: Completed
• Phase: Phase 2
• Start date: April 12, 2004
• Est. completion date: March 19, 2009

Study information

• Verified date: April 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: March 19, 2009
• Est. primary completion date: March 19, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Dietary Supplement:
• 25 gm soy protein supplement
25 gm soy protein supplementation administered in equally divided dosage twice daily (12.5 gm)

Other:
• Placebo
Milk protein administered twice daily

Locations

Country	Name	City	State
United States	Atherosclerosis Research Unit, University of Southern California	Los Angeles	California

Sponsors (5)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

United States, 

References & Publications (2)

Henderson VW, St John JA, Hodis HN, Kono N, McCleary CA, Franke AA, Mack WJ; WISH Research Group. Long-term soy isoflavone supplementation and cognition in women: a randomized, controlled trial. Neurology. 2012 Jun 5;78(23):1841-8. doi: 10.1212/WNL.0b013e — View Citation

Hodis HN, Mack WJ, Kono N, Azen SP, Shoupe D, Hwang-Levine J, Petitti D, Whitfield-Maxwell L, Yan M, Franke AA, Selzer RH; Women's Isoflavone Soy Health Research Group. Isoflavone soy protein supplementation and atherosclerosis progression in healthy post — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of Subclinical Atherosclerosis	Rate of change in right distal common carotid artery (CCA) far wall intima-media thickness (um per year) in computer image processed B-mode ultrasonograms.	Baseline x 2 and then every 6 months, up to 2.5 years
Secondary	Change in Neurocognitive Function (Global Cognition)	The specified primary cognitive endpoint compared between treatment groups was change from baseline on a global cognitive composite score calculated as an average of standardized scores for 14 neuropsychological tests weighted by the inverse intertest correlation matrix. Neuropsychological test scores at baseline and follow-up assessments were standardized ([raw score-mean score]/standard deviation) using the baseline means and standard deviations from the entire WISH sample. Each of 3 cognitive composite scores was calculated at baseline and follow-up as the weighted average of the individual donor standardized test scores weighted by the inverse correlation among tests. Change from baseline (endpoint minus baseline cognitive outcome) was computed for each cognitive score (verbal memory, global cognition, executive function). Since the outcome is not a single test but a weighted average of multiple tests, the range is not standardized and there are no established clinical thresholds.	Baseline and 2.5 years