Soy Nuts and Cardiovascular Risk in Postmenopausal Women

Not Applicable

Completed

• Conditions: Postmenopausal Women
• Interventions: Other: soy nuts

• Registration Number: NCT01740076
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

To determine the effect of a whole soy food, dietary soy nuts, on blood pressure, lipid levels, inflammation and menopausal symptoms in postmenopausal women.

Detailed Description

The present study examines the effect of a whole soy food, soy nuts (dry roasted soybeans), added to the Therapeutic Lifestyle Change diet on blood pressure, lipids, inflammation and menopausal symptoms in postmenopausal hypertensive and normotensive women in a randomized crossover trial during an 8-week period. We sought to determine whether dietary soy had an additional benefit to the currently recommended heart healthy diet.

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2004-07
• Study Completion: 2012-11
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Women with absence of menses for at least 12 months or irregular periods and hot flashes.

Exclusion Criteria

• were current cigarette smoking or smoking in the previous year;
• clinical coronary artery disease, peripheral artery disease, or cerebrovascular disease;
• known diabetes mellitus or a fasting glucose level of 126 mg/dL or greater;
• a history of breast cancer; a fasting triglyceride level greater than 400 mg/dL; systolic BP of 165 mm Hg or greater or diastolic BP of 100 mm Hg or greater;
• untreated hypothyroidism; systemic or endocrine disease known to affect lipid, mineral, or bone metabolism;
• and consumption of more than 21 alcoholic drinks per week.
• Use of lipid-lowering drugs, hormone therapy, medications for osteoporosis, and soy products was discontinued for 2 months before entering the study. Participants took a multivitamin but no additional vitamin or mineral supplements or other soy products during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Therapeutic lifestyle change diet	soy nuts	Counseling on therapeutic lifestyle change diet consisting of 30% of energy from total fat (\<7% saturated fat, 12% monounsaturated fat and 11% polyunsaturated fat), 15% from protein and 55% from carbohydrate; less than 200 mg of cholesterol per day and 1200 mg of calcium and 2 fatty fish meals per week. Those ingesting suboptimal dietary calcium were given calcium carbonate supplementation.
soy nuts	soy nuts	25 g of soy nuts provided daily to the subjects and they were counseled to replace 25 g of protein in their therapeutic lifestyle change (TLC) diet with the soy. TLC diet consisted of 30% of energy from total fat (\<7% saturated fat, 12% monounsaturated fat and 11% polyunsaturated fat), 15% from protein and 55% from carbohydrate; less than 200 mg of cholesterol per day and 1200 mg of calcium and 2 fatty fish meals per week. Those ingesting suboptimal dietary calcium were given calcium carbonate supplementation.

Primary Outcome Measures

Name	Time	Method
Blood pressure	8 weeks	stratified by hypertensive status (normal BP, prehypertension, hypertension)

Secondary Outcome Measures

Name	Time	Method
lipid levels	8 weeks	stratified by hypertension status (normotensive or hypertensive)
menopausal symptoms	8 weeks
inflammatory markers	8 weeks	stratified by hypertensive status (normotensive or hypertensive)

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States