Diet and Estrogen Metabolism in Postmenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): fat reduction with increased fiber; fat reduction without increased fiber
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: breast cancer