Diet and Estrogen Metabolism in Postmenopausal Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: February 2001

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 Intervention
Breast Cancer
Other: preventative dietary intervention

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Diet and Estrogen Metabolism in Postmenopausal Women

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: August 1997
Detailed 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.


Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier: NCT00003098

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: David Heber, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided Identifier: NCT00003098     History of Changes
Other Study ID Numbers: CDR0000065828, UCLA-HSPC-950942302, NCI-P97-0112
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer processed this record on November 24, 2015