Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003098
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
1999-11-01
Brief Title:
Diet and Estrogen Metabolism in Postmenopausal Women
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Diet and Estrogen Metabolism in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2016-01
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:
RATIONALE The amount of dietary fat or fiber may affect estrogen metabolism in postmenopausal women and this may affect the risk of developing cancer
PURPOSE Randomized dietary intervention to study the effectiveness of a low-fat diet combined with either high fiber or low fiber on estrogen metabolism in healthy postmenopausal women
PURPOSE Randomized dietary intervention to study the effectiveness of a low-fat diet combined with either high fiber or low fiber on estrogen metabolism in healthy postmenopausal women
Detailed Description:
OBJECTIVES I Determine the effect of a low fat diet combined with either high fiber 25-35 grams per day or low fiber 10-15 grams per day intake on estrogen metabolism in healthy postmenopausal women
OUTLINE This is a randomized study Patients are randomized to one of 2 arms dietary fat reduction with and without increased fiber All patient must successfully complete a dietary run-in phase for 4 weeks before randomization During the run-in phase patients are asked to maintain a food record for days 7-14 Patients undergo radioisotopic infusion study of sex steroid metabolism on days 14 21 and 28 Patients are given 3 prepackaged meals a day for 12 weeks Patients must maintain a record of all food eaten and return all food containers to the center for documentation Patients undergo radioisotopic infusion study of sex steroid metabolism on days 70 77 and 84 At the end of the 12 weeks patients meet with the dietitian for 30 minutes to receive instructions on maintaining a low fat high fiber diet for the second phase of the study
PROJECTED ACCRUAL 40 women will be accrued over 4 years
OUTLINE This is a randomized study Patients are randomized to one of 2 arms dietary fat reduction with and without increased fiber All patient must successfully complete a dietary run-in phase for 4 weeks before randomization During the run-in phase patients are asked to maintain a food record for days 7-14 Patients undergo radioisotopic infusion study of sex steroid metabolism on days 14 21 and 28 Patients are given 3 prepackaged meals a day for 12 weeks Patients must maintain a record of all food eaten and return all food containers to the center for documentation Patients undergo radioisotopic infusion study of sex steroid metabolism on days 70 77 and 84 At the end of the 12 weeks patients meet with the dietitian for 30 minutes to receive instructions on maintaining a low fat high fiber diet for the second phase of the study
PROJECTED ACCRUAL 40 women will be accrued over 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| UCLA-HSPC-950942302 | OTHER | None | None |
| NCI-P97-0112 | OTHER | PDQ Idenifier | None |