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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003098
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: February 2001
History of Changes

November 1, 1999
February 6, 2009
August 1997
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Complete list of historical versions of study NCT00003098 on ClinicalTrials.gov Archive Site
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Diet and Estrogen Metabolism in Postmenopausal Women
Diet and Estrogen Metabolism in Postmenopausal Women

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.

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.
Interventional
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Primary Purpose: Prevention
Breast Cancer
Other: preventative dietary intervention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
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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
Female
50 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003098
CDR0000065828, UCLA-HSPC-950942302, NCI-P97-0112
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Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: David Heber, MD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
February 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP