Diet and Estrogen Metabolism in Postmenopausal Women

Breast Cancer Clinical Trial

Official title: Diet and Estrogen Metabolism in Postmenopausal Women

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer

• NCT number: NCT00003098
• Study type: Interventional
• Source: Jonsson Comprehensive Cancer Center
• Status: Completed
• Phase: N/A
• Start date: August 1997
• Completion date: June 2004