Soy Protein and Breast Cancer Risk Reduction

Breast Cancer Clinical Trial

Official title:

Soybean Diet and Breast Density

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204477
• Other study ID #: 02-422
• Secondary ID: Army's HSRRB log
• Status: Completed
• Phase: Phase 2
• Start date: April 2002
• Est. completion date: May 29, 2023

Study information

• Verified date: December 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 comparing to casein protein.

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, and bone density will be assessed by radiological techniques at baseline and 1 yr and 2 yr after protein drink supplementation. The efficacy of the dietary intervention will be determined by comparing mean changes of ovarian steroids, and density of the breast and bone tissues 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: May 29, 2023
• Est. primary completion date: July 22, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Dietary Supplement:
• soy milk
Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.
• cow's milk
Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.

Locations

Country	Name	City	State
United States	General Clinical Research Center, The University of Texas Medical Branch	Galveston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	National Center for Research Resources (NCRR), U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Will be Measured for Standard Clinical Chemistries	Serum will be measured for for blood chemistries , 4 times at baseline, and thereafter at 3-monthly interval for up to 2 years of protein drink supplementation	4 measurements at baseline and once every three months after protein drink supplements for up to 2 years.
Other	Progesterone (ng/ml)	Serum will be measured for progesterone (ng/ml), 4 times at baseline, and thereafter at 3-monthly interval for up to 2 years of protein drink supplementation	4 measurements at baseline and once every three months after protein drink supplements for up to 2 years.
Primary	Mammographic Density (Baseline)	Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.	Baseline
Primary	Mammographic Density (1 Year)	Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.	1 Year
Primary	Mammographic Density (2 Years)	Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.	2 years
Primary	Breast Tissue Composition Measured by MRI	Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.	Baseline
Primary	Breast Tissue Composition Measured by MRI	Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.	1 Year
Primary	Breast Tissue Composition Measured by MRI	Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.	2 years
Primary	Percentage of Grandular Tissue in Total Breast Measured by MRI	Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.	Baseline
Primary	Percentage of Grandular Tissue in Total Breast Measured by MRI	Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.	1 Year
Primary	Percentage of Grandular Tissue in Total Breast Measured by MRI	Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.	2 years