Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Bone Density Conservation Agents

Herbal and Botanical

Hormones

Calcium

Caseins

Calcium, Dietary

Soy Bean

Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free 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.

Subjects will consume two cow's milk drinks from 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. Casein is free of ovarian hormones.

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.

soy 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.

cow's milk

Lee-Jane W Lu, Ph.D.

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.

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.

Randomized, double-blind, placebo controlled, 2 parallel groups

Research pharmacist dispensed blinded assigned sachets according to a pre-generated randomization list. Pharmacists were blinded to all other aspects of the research protocols.

Subjects, investigators, research staff, and statisticians were all blinded to treatment assignment.

Only females with regular monthly menstrual cycles, not expecting to become pregnancy, not breast feeding, and not on contraceptives

Soy Protein and Breast Cancer Risk Reduction

Soybean Diet and Breast Density

Will not share as this required financial resources.

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

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

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.

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.

U.S. Army Medical Research and Development Command

National Center for Research Resources (NCRR)

The University of Texas Medical Branch, Galveston

Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free 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.

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.

Soy Milk

Subjects will consume two cow's milk drinks from 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. Casein is free of ovarian hormones.

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.

Cow's Milk

Total

Ages from 29 to 41

Agesfrom 30 to 41

Age, Customized

Sex: Female, Male

American Indian/Alaskan

Asian

Black/African American

Hispanic or Latino

Other (>2 races)

Caucasian

Race/Ethnicity, Customized

United States

Region of Enrollment

Leejane W. Lu

4 participants images in the cow's milk and 3 images in soy milk were either missing or corrupt.

Mammographic Density (Baseline)

Mammographic Density (1 Year)

Participants completed 2 years of study. 1 image missing from the cow's milk group due to it was corrupt.

Mammographic Density (2 Years)

Fatty Breast Tissue, cc

Glandular Breast Tissue, cc

Total Breast, cc

4 participants images in the cow's milk and 14 images in soy milk were either missing or corrupt.

Spots Global Cancer Trial Database for cow's milk

Every month we try and update this database with for cow's milk cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cow's milk

Every month we try and update this database with for cow's milk cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cow's milk cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.