Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments soy protein, cow's milk protein
Phase phase 2
Sponsor The University of Texas Medical Branch, Galveston
Collaborator U.S. Army Medical Research and Materiel Command
Start date April 2002
End date December 2015
Trial size 313 participants
Trial identifier NCT00204477, 02-422, 1UL1RR029876-01, Army's HSRRB log no. A-10926, DAMD17-01-1-0417, M01RR000073, UTMB GCRC 533

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Subjects will consume the content of 2 sachets (40 g soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with ~1.6 liter of water for ingestion.
soy protein Not applicalbe, research product
soy protein
(Placebo Comparator)
Subjects will consume the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with ~1.6 liter of water for ingestion.
cow's milk protein Not applicable, research product
cow's milk protein

Primary Outcomes

Measure
mammographic density
time frame: once per year for two years

Secondary Outcomes

Measure
ovarian hormones, bone density
time frame: once per year for two years

Eligibility Criteria

Female participants from 30 years up to 40 years old.

Inclusion Criteria: - healthy premenopausal women - 30 to 40 years old - normal mammograms - regular menstrual cycles Exclusion Criteria: - abnormal mammograms - first degree relatives with breast cancer - pregnant or lactating - peri- or post-menopause - breast augmentation, reduction, and lifting - on oral contraceptive medications or exogenous hormones - medically prescribed diets - allergic reaction to soy or cow's milk

Additional Information

Official title Soybean Diet and Breast Density
Principal investigator Lee-Jane W Lu, Ph.D.
Description The aims will be tested by conducting a randomized, double-blind study, with two arms and 100 women in each arm. Premenopausal women will be recruited and randomly allocated to take one of two different dietary supplements daily for 2 years. The two test diets soy protein drink and caseinate protein drink. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary intervention period and analyzed for ovarian hormones. At baseline and after the intervention period, breast density will be assessed by radiological techniques. The efficacy of the dietary intervention will be determined by comparing mean changes of ovarian steroids and dense breast tissue over the 2 year dietary intervention period in the two diet groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soya dietary supplements will reduce breast density, which will be explained by individual hormonal changes.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston.