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| ID | Type | Description | Link |
|---|---|---|---|
| Army's HSRRB log no. A-10926 | Other Identifier | USA MRMC Human Research Protection Office (HRPO) | |
| UTMB GCRC 533 | Other Identifier | UTMB ITSCRC | |
| DAMD17-01-1-0417 | Other Grant/Funding Number | USA MRMC | |
| M01RR000073 | U.S. NIH Grant/Contract | View source | |
| 1UL1RR029876-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
| National Center for Research Resources (NCRR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soy milk | Active Comparator | 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. |
|
| Cow's milk | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Only females with regular monthly menstrual cycles, not expecting to become pregnancy, not breast feeding, and not on contraceptives
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| Name | Affiliation | Role |
|---|---|---|
| Lee-Jane W Lu, Ph.D. | The University of Texas Medical Branch, Galveston, TX 77555 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Research Center, The University of Texas Medical Branch | Galveston | Texas | 77555-0264 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23044556 | Derived | Lu LJ, Nishino TK, Johnson RF, Nayeem F, Brunder DG, Ju H, Leonard MH, Grady JJ, Khamapirad T. Comparison of breast tissue measurements using magnetic resonance imaging, digital mammography and a mathematical algorithm. Phys Med Biol. 2012 Nov 7;57(21):6903-27. doi: 10.1088/0031-9155/57/21/6903. Epub 2012 Oct 9. | |
| 20874659 | Derived | Nayeem F, Anderson KE, Nagamani M, Grady JJ, Lu LJ. Alkaline phosphatase and percentage body fat predict circulating C-reactive protein in premenopausal women. Biomarkers. 2010 Dec;15(8):663-70. doi: 10.3109/1354750X.2010.509811. Epub 2010 Sep 29. |
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Will not share as this required financial resources.
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| ID | Title | Description |
|---|---|---|
| FG000 | Soy Milk | 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. |
| FG001 | Cow's 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| One Year After Diet |
| |||||||||||||
| Two Years After Diet |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Soy Milk | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 4 participants images in the cow's milk and 3 images in soy milk were either missing or corrupt. | Posted | Mean | Standard Deviation | percentage of glandular tissue in breast | Baseline |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Soy Milk | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| accident | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leejane W. Lu | University of Texas Medical Branch Galveston | (409)772-1011 | llu@utmb.edu |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D041942 | Soy Milk |
| D008892 | Milk |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Randomized, double-blind, placebo controlled, 2 parallel groups
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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.
|
| 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. |
|
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | Cow's 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Cow's 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. |
|
|
| 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. | Participants completed one year of diet. | Posted | Mean | Standard Deviation | percentage of glandular tissue in 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. | Participants completed 2 years of study. 1 image missing from the cow's milk group due to it was corrupt. | Posted | Mean | Standard Deviation | percentage of glandular tissue in 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. | 4 participants images in the cow's milk and 14 images in soy milk were either missing or corrupt. | Posted | Mean | Standard Deviation | cc | 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. | Participants completed year 1. | Posted | Mean | Standard Deviation | cc | 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. | Posted | Mean | Standard Deviation | cc | 2 years |
|
|
|
| Other Pre-specified | 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 | Not Posted | 4 measurements at baseline and once every three months after protein drink supplements for up to 2 years. | Participants |
| Other Pre-specified | 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 | Not Posted | 4 measurements at baseline and once every three months after protein drink supplements for up to 2 years. | Participants |
| 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. | 4 participants images in the cow's milk and 14 images in soy milk were either missing or corrupt. | Posted | Mean | Standard Deviation | % of glandular tissue in total breast | 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. | Participants completed year 1. | Posted | Mean | Standard Deviation | % of glandular tissue in total breast | 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. | Posted | Mean | Standard Deviation | % of glandular tissue in total breast | 2 years |
|
|
|
| 0 |
| 161 |
| 0 |
| 161 |
| 28 |
| 161 |
| EG001 | Cow's 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. | 0 | 160 | 0 | 160 | 21 | 160 |
| appendectomy | Gastrointestinal disorders | Non-systematic Assessment |
|
| hypertension | Cardiac disorders | Non-systematic Assessment |
|
| blurred vision | Eye disorders | Non-systematic Assessment |
|
| optic migraines | Nervous system disorders | Non-systematic Assessment |
|
| Heavy bleeding and uterine polyp | Reproductive system and breast disorders | Non-systematic Assessment |
|
| cholecystectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | broken left wrist |
|
| pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| urinary tract infection and kidney stones | Renal and urinary disorders | Non-systematic Assessment |
|
| fever, abdominal pain, leucopenia of unknown etiology | General disorders | Non-systematic Assessment |
|
| strep throat | Infections and infestations | Non-systematic Assessment |
|
| enlarged uterus and large fibroids | Reproductive system and breast disorders | Non-systematic Assessment |
|
| idiopathic thrombocytopanic purpura | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| mild stroke | Nervous system disorders | Non-systematic Assessment |
|
| adenopathy in both axilla | Infections and infestations | Non-systematic Assessment |
|
| ovariectomy (1) and follipian tube removed | Surgical and medical procedures | Systematic Assessment |
|
| fever, earache, and hearing loss in left ear | Infections and infestations | Non-systematic Assessment |
|
| bladder infection | Infections and infestations | Non-systematic Assessment |
|
| accident, fall, rib broke, ankle sprained | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| right breast lump | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| recurrent endometriosis, surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| tosillitis and UTI | Infections and infestations | Non-systematic Assessment |
|
| sprain/fracture wrist | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| blood nipple, one | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| laparoscopic lap band elective surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| allergic reaction | Immune system disorders | Non-systematic Assessment |
|
| fibroid, irregular bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| goiter surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| tattoos removal | General disorders | Non-systematic Assessment |
|
| fibroadnoma of right breast | Reproductive system and breast disorders | Non-systematic Assessment |
|
| uterus, laproscopy, D&C | Reproductive system and breast disorders | Non-systematic Assessment |
|
| cervix, polyp, bacterial vaginosis | Reproductive system and breast disorders | Non-systematic Assessment |
|
| leucopenia, fever, abdominal pain | Infections and infestations | Non-systematic Assessment |
|
| accident | General disorders | Non-systematic Assessment | car accident |
|
| pre existing abnormal pap | Reproductive system and breast disorders | Non-systematic Assessment |
|
| accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | bicycle accident |
|
| leiomyomata | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Breast calcification, increase | Reproductive system and breast disorders | Systematic Assessment |
|
| Basal cell carcinoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
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| D017437 |
| Skin and Connective Tissue Diseases |
| D045730 |
| Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D005502 | Food |
| D019602 | Food and Beverages |
| D003611 | Dairy Products |
| Total Breast, cc |
|
| Total Breast, cc |
|
| Total Breast, cc |
|