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Effects of a Western-type Diet on Colorectal Inflammation, Gut Permeability and Systemic Endotoxemia

Phase 0
50 Years
72 Years
Not Enrolling
Colorectal Inflammation

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Trial Information

Effects of a Western-type Diet on Colorectal Inflammation, Gut Permeability and Systemic Endotoxemia

Hypothesis: Compared to a prudent-style diet, does a western-style diet increase colorectal
inflammation thereby increasing gut permeability and causing increased endotoxins and
markers of systemic inflammation.

This is a single blind crossover study. Subjects will be randomized to begin on either a WD
or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a
four (4) week wash-out period and then will be placed on the other dietary intervention for
30 + 3 days. The following study measures are performed during both the dietary intervention
study periods. All the baseline tests will be repeated at the end of each dietary
intervention period.

Inclusion Criteria:

- 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

Exclusion Criteria:

- Personal history of cancer other than non-melanoma skin cancer within the past 10

- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Outcome Measure:

Inflammation in the rectosigmoid epithelium

Outcome Time Frame:

visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention

Safety Issue:


Principal Investigator

Swaroop Pendyala, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rockefeller University


United States: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

February 2010

Related Keywords:

  • Colorectal Inflammation
  • Inflammation



Rockefeller UniversityNew York, New York  10021