Trial Information

Diet and Estrogen Metabolism in Postmenopausal Women

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.