Effects of a Western-type Diet on Colorectal Inflammation

Colorectal Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866450
• Other study ID #: SWP-0658
• Status: Completed
• Phase: Phase 0
• First received: March 19, 2009
• Last updated: January 10, 2012
• Start date: February 2009
• Est. completion date: February 2010

Study information

• Verified date: January 2012
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 72 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Colorectal Inflammation
• Inflammation

Intervention

Dietary Supplement:
• Western style diet (high fat and low in calcium)
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
• Prudent-style diet (low fat and high in calcium)
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

Locations

Country	Name	City	State
United States	Rockefeller University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation in the rectosigmoid epithelium		visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention	No
Secondary	Circulating endotoxin levels		visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention	No
Secondary	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	No
Secondary	Gut permeability		visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention	No
Secondary	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	No
Secondary	Luminal and adherent gut microbiota		visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention	No
Secondary	Fecal calprotectin levels in the stool samples		visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention	No