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| ID | Type | Description | Link |
|---|---|---|---|
| UTMB GCRC #635 | Other Identifier | UTMB ITSCRC | |
| R01CA095545 | U.S. NIH Grant/Contract | View source | |
| M01RR000073 | U.S. NIH Grant/Contract | View source | |
| 1UL1RR029876-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Center for Research Resources (NCRR) | NIH |
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Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities, breast density and possibly bone density will be lower in women on soy-isoflavones.
This is 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 the two different dietary supplements in pills daily for 2 years. The two supplements are soy isoflavones (treatment) and placebo (carbohydrates). Both treatment and placebo pills will contain multi-vitamins and minerals. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary supplement periods and analyzed for biomarkers of breast cancer risk. At baseline and after the intervention period, breast density and bone density will be assessed by radiologic techniques. The efficacy of the dietary intervention will be determined by comparing mean changes of serum markers for breast cancer risk,dense breast tissue, and bone mineral density over the two year dietary intervention period in the two supplement groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soy isoflavone supplement will reduce breast density, which may be explained by individual changes in serum markers of breast cancer risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | soy isoflavones |
|
| 2 | Placebo Comparator | carbohydrates (maltodextrin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isoflavones | Dietary Supplement | soy isoflavones: Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other innert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for upto 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Fibroglandular Tissue in Total Breast (FGBT%) | Effects of 1 and 2 years of treatment with isoflavones on percent of changes in FGBT%. | baseline, and after year 1 and 2 of supplementation |
| Breast Density by Mammography | Area of FGBT in mammogram. The timepoints were combined and summed. | baseline, and after year 1 and 2 of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density | Bone mineral density of hip, spine and whole body bone mineral density as measured by dual x-ray absorptiometry. The timepoints were combined and summed. | one and two years after dietary supplement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee-Jane W Lu, Ph.D. | The University of Teas Medical Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Reserach Center, The University of Texas Medical Branch | Galveston | Texas | 77555-0264 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36513449 | Derived | Lu LW, Chen NW, Brunder DG, Nayeem F, Nagamani M, Nishino TK, Anderson KE, Khamapirad T. Soy isoflavones decrease fibroglandular breast tissue measured by magnetic resonance imaging in premenopausal women: A 2-year randomized double-blind placebo controlled clinical trial. Clin Nutr ESPEN. 2022 Dec;52:158-168. doi: 10.1016/j.clnesp.2022.10.007. Epub 2022 Oct 26. | |
| 31535213 | Derived | Lu LW, Chen NW, Nayeem F, Nagamani M, Anderson KE. Soy isoflavones interact with calcium and contribute to blood pressure homeostasis in women: a randomized, double-blind, placebo controlled trial. Eur J Nutr. 2020 Sep;59(6):2369-2381. doi: 10.1007/s00394-019-02085-3. Epub 2019 Sep 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Soy Isoflavones | Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other inert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for up to 2 years. |
| FG001 | Placebo | Carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other inert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for up to 2 years. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment/Allocation of Qualified Women |
| |||||||||||||
| Follow-up <1 Year |
| |||||||||||||
| Follow-up >1 to <2 Years |
| |||||||||||||
| Follow-up 2 Years |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Soy Isoflavones | Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other inert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for up to 2 years. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Fibroglandular Tissue in Total Breast (FGBT%) | Effects of 1 and 2 years of treatment with isoflavones on percent of changes in FGBT%. | Subjects with at least 1 treatment image. | Posted | Mean | Standard Deviation | percentage of total breast tissue | baseline, and after year 1 and 2 of supplementation |
|
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 Isoflavones | Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other inert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for up to 2 years. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lee Jane W. Lu | University of Texas Medical Branch Galveston | 409-772-1730 | llu@utmb.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2014 | Dec 5, 2023 | Prot_SAP_000.pdf |
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| 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 |
|---|---|
| D007529 | Isoflavones |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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One group received soy isoflavones (60 mg daidzein, 60 mg gensitein and 16.6 mg glycitein, all as aglycone equivalent) Another group, carbohydrate filler
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Research pharmacist dispensed study pills according to a pre-generated randomization list and were blinded to all other aspects of the study protocol.
Subjects, research staff, investigators, and statistician all were blinded to treatment assignment.
|
|
| carbohydrate | Dietary Supplement | carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other innert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for upto 2 years. |
|
|
| 29183775 | Derived | Lu LW, Chen NW, Nayeem F, Ramanujam VS, Kuo YF, Brunder DG, Nagamani M, Anderson KE. Novel effects of phytoestrogenic soy isoflavones on serum calcium and chloride in premenopausal women: A 2-year double-blind, randomized, placebo-controlled study. Clin Nutr. 2018 Dec;37(6 Pt A):1862-1870. doi: 10.1016/j.clnu.2017.11.002. Epub 2017 Nov 11. |
| 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. |
| NOT COMPLETED |
|
| NOT COMPLETED |
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| NOT COMPLETED |
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Carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other inert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for up to 2 years. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| FGBT% | One placebo and 4 isoflavone participants had missing or unsatisfactory baseline images. | Mean | Standard Deviation | percentage of total breast |
|
|
|
|
| Primary | Breast Density by Mammography | Area of FGBT in mammogram. The timepoints were combined and summed. | Three Soy Isoflavones participants had missing mammograms. | Posted | Mean | Standard Deviation | percentage of total breast | baseline, and after year 1 and 2 of supplementation |
|
|
|
| Secondary | Bone Mineral Density | Bone mineral density of hip, spine and whole body bone mineral density as measured by dual x-ray absorptiometry. The timepoints were combined and summed. | Intention to treat participants. Two placebo and one isoflavone subjects had breast images but no DXA tests. | Posted | Mean | Standard Deviation | g/cm^2 | one and two years after dietary supplement |
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 1 |
| 99 |
| EG001 | Placebo | Carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other inert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for up to 2 years. | 0 | 98 | 0 | 98 | 6 | 98 |
| Presynocopy | Nervous system disorders | Systematic Assessment |
|
| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ear Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Lower Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | Systematic Assessment |
|
| uterus, cervix, cyst and polyp in cervix | Reproductive system and breast disorders | Systematic Assessment |
|
| Appendicitis | Infections and infestations | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Unknown or Not Reported |
|
| Whole body bone mineral density |
|