Soy Nuts and Cardiovascular Risk in Postmenopausal Women

Effect of Soy Nuts on Blood Pressure, Lipids and Inflammation 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.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Women
• Intervention / Treatment: Other: soy nuts

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: soy nuts; 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.	Other: soy nuts
Other: Therapeutic lifestyle change diet; 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.	Other: soy nuts

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Francine Welty, MD, PhD, Beth Israel Deaconess Medical Center

Publications and helpful links

General Publications

• Acharjee S, Zhou JR, Elajami TK, Welty FK. Effect of soy nuts and equol status on blood pressure, lipids and inflammation in postmenopausal women stratified by metabolic syndrome status. Metabolism. 2015 Feb;64(2):236-43. doi: 10.1016/j.metabol.2014.09.005. Epub 2014 Oct 5.

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): July 1, 2004
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: isoflavones, hypertension, soy, diet, nutrition, women, inflammation, hot flashes
• Other Study ID Numbers: 2001P001604