Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Prevention Active 30 to 40 Other 02-422 Army's HSRRB log no. A-10926, UTMB GCRC 533, DAMD17-01-1-0417, NIH NCRR GCRC M01 RR00073, NCT00204477

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Texas Medical Branch

Lee-Jane W Lu, Ph.D.

Principal Investigator

Lee-Jane W Lu, Ph.D.		Ph: 409 772 4661
		Email: llu@utmb.edu

Karl E Anderson, M.D.		Ph: 409 772 4661
		Email: kanderso@utmb.edu

U.S.A.
Texas
	Galveston
	University of Texas Medical Branch
		Lee-Jane W Lu, Ph.D.	Ph: 409-772-4661
			Email: llu@utmb.edu
		Elizabeth B Ruiz	Ph: 409 772 1950
			Email: ebruiz@utmb.edu
		Lee-Jane W Lu, Ph.D.	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00204477
Information obtained from ClinicalTrials.gov on July 16, 2008