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Soy Nuts and Cardiovascular Risk in Postmenopausal Women

Beth Israel Lahey Health logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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