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
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00204477
First received: September 9, 2005
Last updated: June 5, 2014
Last verified: June 2014

September 9, 2005
June 5, 2014
April 2002
December 2014   (final data collection date for primary outcome measure)
mammographic density [ Time Frame: once per year for two years ] [ Designated as safety issue: Yes ]
mammographic density
Complete list of historical versions of study NCT00204477 on ClinicalTrials.gov Archive Site
ovarian hormones, bone density [ Time Frame: once per year for two years ] [ Designated as safety issue: Yes ]
ovarian hormones
Not Provided
Not Provided
 
Soy Protein and Breast Cancer Risk Reduction
Soybean Diet and Breast Density

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Breast Cancer
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
313
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Female
30 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00204477
02-422, Army's HSRRB log no. A-10926, UTMB GCRC 533, DAMD17-01-1-0417, M01RR000073, 1UL1RR029876-01
No
The University of Texas, Galveston
The University of Texas, Galveston
  • U.S. Army Medical Research and Materiel Command
  • National Center for Research Resources (NCRR)
Principal Investigator: Lee-Jane W Lu, Ph.D. The University of Texas Medical Branch, Galveston, TX 77555
The University of Texas, Galveston
June 2014

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