Effects of a Western-type Diet on Colorectal Inflammation
Completed · Early Phase 1
Conditions studied: Colorectal Inflammation
In brief
This study will look at the inflammatory (changes usually associated with infection/injury to the body) and bowel permeability (bowel's ability to allow contents to enter the body) effects of a Western-style diet (high fat and low in calcium) and a prudent-style diet (low fat and high in calcium) on the colon (large bowel). This study may provide information to prevent colorectal cancer in a high-risk population
Key facts
- Study ID
- NCT00866450
- Run by
- Rockefeller University
- People needed
- 5
- Starts
- 2009-02-01
- Expected to finish
- 2010-02-01
- Last updated by the study team
- 2012-01-11
Who can join
Age: 50 and older, up to 72. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Healthy male or post-menopausal ( 2 years after menopause or stopping HRT)healthy female subjects
- Age between 50 and 72 years
- At increased risk for colorectal cancer (this includes those have had a colorectal adenoma excised, or have a first or second degree relative with colorectal neoplasia).
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 or inflammation
- Total cholesterol greater than 240mg/dl, triglycerides > 600mg, LDL-C > 175
- Subjects with a history of coronary artery disease
- 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 subject is euthyroid)
- Currently participating in other clinical studies or completed participation in other clinical studies within the last 30 days
Where it is running
- Rockefeller University — New York, New York, United States
Full record on ClinicalTrials.gov
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