Soy Protein and Breast Cancer Risk Reduction

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

U.S. Army Medical Research and Materiel Command

National Center for Research Resources (NCRR)

Information provided by (Responsible Party):

The University of Texas, Galveston

ClinicalTrials.gov Identifier:

NCT00204477

First received: September 9, 2005

Last updated: May 1, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

May 1, 2012

Start Date ^ICMJE

April 2002

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

mammographic density [ Time Frame: once per year for two years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

mammographic density

Change History

Complete list of historical versions of study NCT00204477 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

ovarian hormones, bone density [ Time Frame: once per year for two years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

ovarian hormones

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Soy Protein and Breast Cancer Risk Reduction

Official Title ^ICMJE

Soybean Diet and Breast Density

Brief 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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Dietary Supplement: soy protein
soy protein

Other Name: Not applicalbe, research product
Dietary Supplement: cow's milk protein
cow's milk protein

Other Name: Not applicable, research product

Study Arm (s)

Experimental: 1
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.

Intervention: Dietary Supplement: soy protein
Placebo Comparator: 2
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.

Intervention: Dietary Supplement: cow's milk protein

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

313

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

30 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00204477

Other Study ID Numbers ^ICMJE

02-422, Army's HSRRB log no. A-10926, UTMB GCRC 533, DAMD17-01-1-0417, M01RR000073, 1UL1RR029876-01

Has Data Monitoring Committee

Responsible Party

The University of Texas, Galveston

Study Sponsor ^ICMJE

The University of Texas, Galveston

Collaborators ^ICMJE

U.S. Army Medical Research and Materiel Command
National Center for Research Resources (NCRR)

Investigators ^ICMJE

Principal Investigator:

Lee-Jane W Lu, Ph.D.

The University of Texas Medical Branch, Galveston, TX 77555

Information Provided By

The University of Texas, Galveston

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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