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Diet and Estrogen Metabolism in Postmenopausal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003098
First Posted: May 24, 2004
Last Update Posted: February 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
  Purpose

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: fat reduction with increased fiber Other: fat reduction without increased fiber

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Diet and Estrogen Metabolism in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Enrollment: 12
Study Start Date: August 1997
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fat reduction increased fiber
Patients are randomized to dietary fat reduction with 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.
Other: fat reduction with increased fiber
Patients are randomized to dietary fat reduction with 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.
Experimental: fat reduction without increased fiber
Patients are randomized to dietary fat reduction 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.
Other: fat reduction without increased fiber
Patients are randomized to dietary fat reduction 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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003098


Locations
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)
Investigators
Study Chair: David Heber, MD Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00003098     History of Changes
Other Study ID Numbers: CDR0000065828
UCLA-HSPC-950942302 ( Other Identifier: UCLA )
NCI-P97-0112 ( Other Identifier: PDQ Idenifier )
First Submitted: November 1, 1999
First Posted: May 24, 2004
Last Update Posted: February 1, 2016
Last Verified: January 2016

Keywords provided by Jonsson Comprehensive Cancer Center:
breast cancer

Additional relevant MeSH terms:
Benzocaine
Estrogens
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists