NCT01049386

Intestinal Permeability

Methods to Examine Intestinal Permeability Under Different Conditions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: TNO · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Rationale: Intestinal permeability of subjects can vary depending on their health status. It is therefore important to be able to measure and quantify intestinal permeability in a standardized way. Subjects with intestinal complaints (like irritable bowel disorder) or obese subjects have been found to have increased intestinal permeability. Different physiological conditions might affect intestinal permeability (IP) further. In the clinic, sugar absorption tests and different blood and urine markers have been used to quantify IP. The sugars sucrose, mannitol, sucralose and lactulose are absorbed differently in the small or large intestines, resulting in different sugar levels in urine. This indicates the level of intestinal permeability and the location of increased permeability which is more or less permeable. A high-fat meal could be used as a challenge test to increase IP in subjects even further. After a high fat meal, lipopolysaccharide (LPS) could be co-transported with chylomicrons. Small amounts of LPS co-transit with dietary fat from the gut after a high-fat meal, which thereby increases plasma LPS concentrations. Because of the above mentioned reasons, it could be relevant to determine intestinal permeability and plasma LPS concentration after consumption of a high-fat diet. Different methods will be used to determine the intestinal permeability in lean and obese men, under different conditions. New parameters, like intestinal (I) fatty acid binding protein (I-FABP), liver (L)-FABP, LPS and inflammatory markers will be measured and related to outcomes of tests, to examine the relation with intestinal permeability. The association of IP with whole body electrical resistance will be examined, to determine usefulness of a candidate non-invasive method for IP investigation.

Detailed description

Study design: The study is designed as a randomized, cross-over and open study. Study population: 16 healthy, lean (BMI 20-25 kg.m-2) and obese (BMI 30-35 kg.m-2) male subjects will participate in the study, aged between 18-45 years. Intervention: On two different test days eight lean and eight obese men will be supplied with a sugar drink to examine intestinal permeability under normal conditions and in combination with an oral fat load to examine intestinal permeability under stressed conditions. Main study parameters/endpoints: Intestinal permeability will be examined with an absorption test using four different sugars (sucrose, mannitol, sucralose and lactulose). New markers of intestinal permeability, like I-FABP, L-FABP, LPS and inflammatory markers will be measured as well.

Conditions

• Intestinal Permeability

Interventions

Type	Name	Description
OTHER	No intervention	In obese and lean subjects the intestinal absorption will be examined under normal conditions with sugar drink, and when disturbed by a high-fat breakfast.
PROCEDURE	Sugar absorption test	On one of the test days the subjects will consume a high-fat breakfast.

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2010-01-14
• Last updated: 2010-07-27

Locations

1 site across 1 country: Netherlands