Soy Nuts and Cardiovascular Risk in Postmenopausal Women

Effect of Soy Nuts on Blood Pressure, Lipids and Inflammation in Postmenopausal Women

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01740076

Enrollment

Registered

2012-12-04

Start date

2001-09-30

Completion date

2012-11-30

Last updated

2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Women

Keywords

isoflavones, hypertension, soy, diet, nutrition, women, inflammation, hot flashes

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.

Interventions

OTHERsoy nuts

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Blood pressure	8 weeks	stratified by hypertensive status (normal BP, prehypertension, hypertension)

Secondary

Measure	Time frame	Description
lipid levels	8 weeks	stratified by hypertension status (normotensive or hypertensive)
inflammatory markers	8 weeks	stratified by hypertensive status (normotensive or hypertensive)
menopausal symptoms	8 weeks	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026