Status:
COMPLETED
Colorectal Inflammatory Response to a Western-Style Diet
Lead Sponsor:
Rockefeller University
Conditions:
Colorectal Cancer
Eligibility:
All Genders
50-72 years
Phase:
NA
Brief Summary
The investigators are involved in a research program to understand how different diets may affect the risk of colorectal polyps and cancer. To that end, the investigators are conducting a study of a w...
Detailed Description
Study subjects participate for about 3 months. During this time, there is one outpatient visit, a 4 week inpatient period, a 4 week outpatient period known as a wash out period and finally another 4 w...
Eligibility Criteria
Inclusion
- Healthy male and post-menopausal healthy female subjects, aged 50-72 years, who have had a colorectal adenoma removed, or have a first or second degree relative with colorectal neoplasia and thus are themselves at risk for colorectal cancer.
Exclusion
- Personal history of cancer other than non-melanoma skin cancer within the past 10 years
- History of hereditary non-polyposis colon cancer
- Intestinal malabsorption, inflammatory bowel disease
- Prior gastrointestinal surgery other than appendectomy or surgery of the esophagus
- Any excess bleeding or coagulation disorders
- Subjects taking anti-coagulants, sterol-binding resins, NSAIDs other than aspirin, \< 600mg per day, other study medications, or other multiple medications that might, in the view of the study physicians, alter colonic function of inflammation
- Sustained blood pressure \> 150/95 mm Hg for three consecutive readings
- Total cholesterol greater than 240mg/dL, triglycerides \>600mg, LDL-C \> 175
- Subjects with a history of coronary artery disease, with EKG changes consistent with a past myocardial infarction
- HIV positive subjects
- Subjects taking antibiotics, anti-diabetes, hormone replacement therapy, oral, transplanted or injected contraceptives (thyroid hormone therapy is permitted as long as the subjects is euthyroid)
- Subjects consuming a vegetarian diet or a very "prudent diet"
- Withdrawal Criteria:
- If a subject is suspected of having taken illicit drugs, the subject will be asked to take a urine test. If positive, the subject will be withdrawn from the study
- The subject takes any medication prescribed without prior approval of the investigator
- Persistent noncompliance with the diets prescribed by the RUH nutritionists
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00932308
Start Date
September 1 2006
End Date
May 1 2008
Last Update
February 17 2012
Active Locations (1)
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1
Rockefeller University
New York, New York, United States, 10065