NCT00866450

Effects of a Western-type Diet on Colorectal Inflammation

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 50 Years – 72 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Inflammation

Interventions

Type	Name	Description
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
DIETARY_SUPPLEMENT	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

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-03-20
• Last updated: 2012-01-11

Locations

1 site across 1 country: United States