Effects of a Western-type Diet on Colorectal Inflammation

Early Phase 1

Completed

• Conditions: Colorectal Inflammation
• Interventions: Dietary Supplement: Western style diet (high fat and low in calcium); Dietary Supplement: Prudent-style diet (low fat and high in calcium)

• Registration Number: NCT00866450
• Lead Sponsor: Rockefeller University

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-19
• Study First Submitted QC: 2009-03-19
• Study First Posted: 2009-03-20
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Western style diet	Western style diet (high fat and low in calcium)	high-fat, low-calcium diet
Prudent diet	Prudent-style diet (low fat and high in calcium)	low-fat, calcium-sufficient diet

Primary Outcome Measures

Name	Time	Method
Inflammation in the rectosigmoid epithelium	visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention

Secondary Outcome Measures

Name	Time	Method
Inflammatory cytokines in the colorectal mucosa and serum	visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention
Circulating endotoxin levels	visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention
Expression profiles of pro- and anti-inflammatory genes in rectosigmoid biopsies	visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention
Gut permeability	visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention
Luminal and adherent gut microbiota	visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention
Fecal calprotectin levels in the stool samples	visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention

Trial Locations

Locations (1)

Rockefeller University; 🇺🇸 New York, New York, United States