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.

Condition	Treatment or Intervention
prevention of breast cancer Breast Cancer	Behavior: Low-fat high fiber diet  Behavior: Low-fat low fiber diet

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  50 Years   -   69 Years

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• No concurrent medication that can interfere with blood test results; No hormone replacement therapy or thyroid hormones

--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

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

Study chairs or principal investigators

David Heber,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000065828; UCLA-HSPC-950942302; NCI-P97-0112
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003098
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08