CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 321 enrolled
Drug / intervention
soy milk +1 moredietary
Likely dose
Soy milk: two drinks per day (177.8 kcal each) or cow's milk: two drinks per day (178.6 kcal each)AI-extracted
Key inclusion· 4
  • Healthy premenopausal women
  • Age 30 to 40 years
  • Normal mammograms
  • Regular menstrual cycles
Key exclusion· 8
  • Abnormal mammograms
  • First-degree relatives with breast cancer
  • Pregnant or lactating
  • Peri- or post-menopausal status

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00204477
NCT00204477Phase 2Completed

Soybean Diet and Breast Density

The University of Texas Medical Branch, Galveston·interventional·Posted Sep 20, 2005·Updated Jan 23, 2024

In Brief

A Phase 2 clinical trial evaluating soy milk and cow's milk for Breast Cancer. Completed, enrolled 321 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartApr 1, 2002
Primary CompletionJul 22, 2011
Study CompletionMay 29, 2023
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 20.8 years ago

Interventions

soy milkdietary

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.

cow's milkdietary

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