Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204477
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2005-09-09
Brief Title:
Soy Protein and Breast Cancer Risk Reduction
Sponsor:
The University of Texas Medical Branch Galveston
Organization:
The University of Texas Medical Branch Galveston
Study Overview
Official Title:
Soybean Diet and Breast Density
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1UL1RR029876-01 | NIH | USA MRMC | httpsreporternihgovquickSearch1UL1RR029876-01 |
| Armys HSRRB log no A-10926 | OTHER | None | None |
| UTMB GCRC 533 | OTHER | None | None |
| DAMD17-01-1-0417 | OTHER_GRANT | None | None |
| M01RR000073 | NIH | None | None |