|
Diet and Estrogen Metabolism in Postmenopausal Women Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Diet and Estrogen Metabolism in Postmenopausal Women conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Diet and Estrogen Metabolism in Postmenopausal Women Clinical research trials and Diet and Estrogen Metabolism in Postmenopausal Women health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Diet and Estrogen Metabolism in Postmenopausal Women. Diet and Estrogen Metabolism in Postmenopausal Women Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Diet and Estrogen Metabolism in Postmenopausal Women clinical trial. Subjects frequently get the best healthcare possible for their Diet and Estrogen Metabolism in Postmenopausal Women condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > Diet and Estrogen Metabolism in Postmenopausal Women  Diet and Estrogen Metabolism in Postmenopausal Women
Diet and Estrogen Metabolism in Postmenopausal Women
For Condition: Breast Cancer,prevention of breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 50 Years/69 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --Prior/Concurrent Therapy-- - No concurrent medication that can interfere with blood test results; No hormone replacement therapy or thyroid hormones --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidHeber, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000065828; UCLA-HSPC-950942302,NCI-P97-0112
Study Start Date: August 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003098
Other Prevention Of Breast Cancer Studies:
1. Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy
2. A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy
3. Indole-3-Carbinol in Preventing Breast Cancer in Nonsmoking Women Who Are at High Risk For Breast Cancer
4. Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
5. Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors
Related Studies:
Other prevention of breast cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Diet and Estrogen Metabolism in Postmenopausal Women
|
|
|
|
|
|
|
|
