NCT01740076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

2.8 years

First QC Date

November 30, 2012

Last Update Submit

May 19, 2025

Conditions

Postmenopausal Women

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

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

    8 weeks

Secondary Outcomes (3)

  • lipid levels

    8 weeks

  • inflammatory markers

    8 weeks

  • menopausal symptoms

    8 weeks

Study Arms (2)

soy nuts

EXPERIMENTAL

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

Therapeutic lifestyle change diet

OTHER

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

Interventions

soy nutsOTHER
Therapeutic lifestyle change dietsoy nuts

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with absence of menses for at least 12 months or irregular periods and hot flashes.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 25441251DERIVED

MeSH Terms

Conditions

HypertensionInflammationHot Flashes

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Francine Welty, MD, PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 4, 2012

Study Start

September 1, 2001

Primary Completion

July 1, 2004

Study Completion

November 1, 2012

Last Updated

May 22, 2025

Record last verified: 2025-05

Locations

US(1)