Clinical trial NCT00866450: Effects of a Western-type Diet on Colorectal Inflammation
Official title: Effects of a Western-type Diet on Colorectal Inflammation, Gut Permeability and Systemic Endotoxemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Colorectal Inflammation
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2009-03-20
Enrollment: 5
Sex: ALL
Minimum age (years): 50
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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 neoplasia).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Inflammation in the rectosigmoid epithelium
timeFrame: visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention
Secondary outcomes:
measure: Circulating endotoxin levels
timeFrame: visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention
measure: Expression profiles of pro- and anti-inflammatory genes in rectosigmoid biopsies
timeFrame: visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention
measure: Gut permeability
timeFrame: visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention
measure: Inflammatory cytokines in the colorectal mucosa and serum
timeFrame: visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention
measure: Luminal and adherent gut microbiota
timeFrame: visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention
measure: Fecal calprotectin levels in the stool samples
timeFrame: visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University
state: New York
Study officials:
affiliation: Rockefeller University
name: Swaroop Pendyala, MD
role: PRINCIPAL_INVESTIGATOR
References: