NCT00201162

Brief Summary

To determine the effects of soy on lipids, lipoproteins and lipoprotein subclass in a sample of African-American and white postmenopausal women with low-density lipoprotein (LDL) cholesterol elevations that may increase their lifetime risk for cardiovascular disease but would not qualify for definite pharmacotherapy under current guidelines.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2001

Longer than P75 for not_applicable

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
4 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

4.9 years

First QC Date

September 16, 2005

Last Update Submit

August 28, 2018

Conditions

AtherosclerosisCardiovascular DiseasesHeart DiseasesMenopause

Outcome Measures

Primary Outcomes (1)

  • LDL cholesterol level

    LDL cholesterol will be measured in blood in mg/dl

    3 months

Study Arms (2)

Intervention

EXPERIMENTAL

dietary supplement soy protein containing isoflavones

Dietary Supplement: Soy

Placebo

PLACEBO COMPARATOR

dietary supplement casein placebo

Dietary Supplement: Placebo

Interventions

SoyDIETARY_SUPPLEMENT

Dietary supplement of isolated soy protein containing isoflavones

Intervention
PlaceboDIETARY_SUPPLEMENT

dietary supplement casein placebo

Placebo

Eligibility Criteria

Age50 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • postmenopausal women
  • elevated cholesterol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AtherosclerosisCardiovascular DiseasesHeart Diseases

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jerilyn Allen

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Study Start

September 1, 2001

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

August 31, 2018

Record last verified: 2018-08