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Diet and Estrogen Metabolism in Postmenopausal Women

50 Years
69 Years
Open (Enrolling)
Breast Cancer

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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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Healthy postmenopausal female between the ages of 50 and 69 with
diet of greater than 32% of total calories from fat and less than 15 grams of fiber

PATIENT CHARACTERISTICS: Age: 50 to 69 Sex: Female Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: At least 2 years since menopause In general good health Increased body
fat (125%-175% of ideal body weight) Increased upper body fat (waist-to-hip circumference
ratio greater than 0.85) Serum estradiol greater than 13 picograms per milliliter

PRIOR CONCURRENT THERAPY: No concurrent medication that can interfere with blood test
results No hormone replacement therapy or thyroid hormones

Type of Study:


Study Design:

Primary Purpose: Prevention

Principal Investigator

David Heber, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1997

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781