Soy Nuts and Cardiovascular Risk in Postmenopausal Women

Beth Israel Lahey Health

Status: Completed

Conditions: Postmenopausal Women

Treatments: Other: soy nuts

Study type: Interventional

Funder types: Other

Identifiers

NCT01740076

2001P001604

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

soy nuts

Experimental group

Description:

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.

Treatment:

Other: soy nuts

Therapeutic lifestyle change diet

Other group

Description:

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.

Treatment:

Other: soy nuts