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Completed

NCT Number: NCT01740076

Soy Nuts and Cardiovascular Risk in Postmenopausal Women

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

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Soy nuts

Other

Primary outcomes

  1. Blood pressure

    Time frame: 8 weeks

    stratified by hypertensive status (normal BP, prehypertension, hypertension)

Secondary outcomes

  1. lipid levels

    Time frame: 8 weeks

    stratified by hypertension status (normotensive or hypertensive)

  2. inflammatory markers

    Time frame: 8 weeks

    stratified by hypertensive status (normotensive or hypertensive)

  3. menopausal symptoms

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2004
Study completion
2012
First posted
Dec 4, 2012
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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