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Soy Protein and Breast Cancer Risk Reduction

NCT00204477 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2024-01-23

Study results available
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Summary

Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian hormones and breast density are considered breast cancer risk markers. We propose to test the hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a corresponding reduction in breast density comparing to casein protein.

Conditions

Interventions

DIETARY_SUPPLEMENT

soy milk

Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.

DIETARY_SUPPLEMENT

cow's milk

Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Lee-Jane W Lu, Ph.D. · The University of Texas Medical Branch, Galveston, TX 77555

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2011-07-22
Completion
2023-05-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00204477 on ClinicalTrials.gov