Diet and Estrogen Metabolism in Postmenopausal Women

NACompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 31, 1997

Primary Completion Date

June 30, 2004

Study Completion Date

June 30, 2004

Conditions
Breast Cancer
Interventions
OTHER

fat reduction with increased fiber

Patients are randomized to dietary fat reduction with 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.

OTHER

fat reduction without increased fiber

Patients are randomized to dietary fat reduction 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.

Trial Locations (1)

90095-1781

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Jonsson Comprehensive Cancer Center

OTHER

NCT00003098 - Diet and Estrogen Metabolism in Postmenopausal Women | Biotech Hunter | Biotech Hunter