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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Dietary Supplement: soy protein
Dietary Supplement: cow's milk protein
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Soybean Diet and Breast Density

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

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

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

Enrollment: 313
Study Start Date: April 2002
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: soy protein
soy protein
Other Name: Not applicalbe, research product
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.
Dietary Supplement: cow's milk protein
cow's milk protein
Other Name: Not applicable, research product

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.

  Eligibility

Ages Eligible for Study:   30 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00204477

Locations
United States, Texas
General Clinical Research Center, The University of Texas Medical Branch
Galveston, Texas, United States, 77555-0264
Sponsors and Collaborators
The University of Texas, Galveston
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Lee-Jane W Lu, Ph.D. The University of Texas Medical Branch, Galveston, TX 77555
  More Information

No publications provided by The University of Texas, Galveston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00204477     History of Changes
Other Study ID Numbers: 02-422, Army's HSRRB log no. A-10926, UTMB GCRC 533, DAMD17-01-1-0417, M01RR000073, 1UL1RR029876-01
Study First Received: September 9, 2005
Last Updated: June 5, 2014
Health Authority: United States: Federal Government

Keywords provided by The University of Texas, Galveston:
soy diet
breast cancer
ovarian hormones
breast density
prevention

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 31, 2014