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Completed

NCT Number: NCT00204477

Soy Protein and Breast Cancer Risk Reduction

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

General Clinical Research Center, The University of Texas Medical Branch

Galveston, Texas, 77555-0264, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

soy milk

Dietary Supplement

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.

Other names: Not applicable, research product

cow's milk

Dietary Supplement

Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.

Other names: Not applicable, research product

Primary outcomes

  1. Mammographic Density (Baseline)

    Time frame: 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.

  2. Mammographic Density (1 Year)

    Time frame: 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.

  3. Mammographic Density (2 Years)

    Time frame: 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.

  4. Breast Tissue Composition Measured by MRI

    Time frame: Baseline

    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.

  5. Breast Tissue Composition Measured by MRI

    Time frame: 1 Year

    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.

  6. Breast Tissue Composition Measured by MRI

    Time frame: 2 years

    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.

  7. Percentage of Grandular Tissue in Total Breast Measured by MRI

    Time frame: Baseline

    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.

  8. Percentage of Grandular Tissue in Total Breast Measured by MRI

    Time frame: 1 Year

    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.

  9. Percentage of Grandular Tissue in Total Breast Measured by MRI

    Time frame: 2 years

    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.

Other outcomes

  1. Blood Will be Measured for Standard Clinical Chemistries

    Time frame: 4 measurements at baseline and once every three months after protein drink supplements for up to 2 years.

    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

  2. Progesterone (ng/ml)

    Time frame: 4 measurements at baseline and once every three months after protein drink supplements for up to 2 years.

    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

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

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

Registry information

Official study title

Soybean Diet and Breast Density

Important dates

Study start
2002
Primary completion
2011
Study completion
2023
First posted
Sep 20, 2005
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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