Clinical trial · Interventional
Diet and Estrogen Metabolism in Postmenopausal Women
NCT00003098CI-TRIAL-00020725completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fat reduction with increased fiber | Other | — | UNRESOLVED |
| fat reduction without increased fiber | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- fat reduction increased fiber
- description
- 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.
- interventionNames
- Other: fat reduction with increased fiber
- type
- EXPERIMENTAL
- label
- fat reduction without increased fiber
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.