Soy Nuts and Cardiovascular Risk in Postmenopausal Women

Postmenopausal Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740076
• Other study ID #: 2001P001604
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: March 29, 2017
• Start date: September 2001
• Est. completion date: November 2012

Study information

• Verified date: March 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 2012
• Est. primary completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postmenopausal Women

Intervention

Other:
• soy nuts

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	stratified by hypertensive status (normal BP, prehypertension, hypertension)	8 weeks
Secondary	lipid levels	stratified by hypertension status (normotensive or hypertensive)	8 weeks
Secondary	inflammatory markers	stratified by hypertensive status (normotensive or hypertensive)	8 weeks
Secondary	menopausal symptoms		8 weeks