Colorectal Inflammatory Response to a Western-Style Diet
Completed · Not applicable
Conditions studied: Colorectal Cancer
In brief
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 western style diet versus a "prudent style" diet in which volunteer subjects are provided a different diet for 2 separate 4 week periods at the Rockefeller University Hospital. During one of these 4 week inpatient periods they receive a Western style diet and during the other 4 week inpatient period they receive a "Prudent style" diet. The investigators will determine changes within the colon as a result of the two different diets. A more detailed description of the study is provided below.
Key facts
- Study ID
- NCT00932308
- Run by
- Rockefeller University
- People needed
- 5
- Starts
- 2006-09-01
- Expected to finish
- 2008-05-01
- Last updated by the study team
- 2012-02-17
Who can join
Age: 50 and older, up to 72. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Rockefeller University — New York, New York, United States
Full record on ClinicalTrials.gov
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