Intestinal Permeability

NCT01049386 | Completed Phase 2

• 1 other identifier: 8738
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intestinal Permeability

Keywords

intestinal permeability; health; sugar absorption; intestinal permeability examined in different men (lean vs obese) and different conditions (no breakfast and high-fat breakfast)

Outcome Measures

Primary Outcomes (1)

• intestinal absorption (measured with the four sugar absorption test)

  24 hours

Secondary Outcomes (1)

• Different biomarkers for intestinal absorption.

  6 hours

Study Arms (2)

Sugar absorption test

ACTIVE COMPARATOR

In 150 mL of water four different sugars will be dissolved. Absorption will be calculated based on concentrations of sugars in 0-5 hours urine and 0-24 h collected urine.

Other: No intervention; Procedure: Sugar absorption test

Sugar absorption test and high-fat breakfast

EXPERIMENTAL

In 150 mL of water four different sugars will be dissolved. Absorption will be calculated based on concentrations of sugars in 0-5 hours urine and 0-24 h collected urine. Subjects will eat a high-fat breakfast together with the sugar drink, to investigate the disturbance caused by fat in intestinal absorption.

Other: No intervention; Procedure: Sugar absorption test

Interventions

No intervention OTHER

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.

Sugar absorption test; Sugar absorption test and high-fat breakfast

Sugar absorption test PROCEDURE

On one of the test days the subjects will consume a high-fat breakfast.

Sugar absorption test; Sugar absorption test and high-fat breakfast

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy as assessed by the
• health and lifestyle questionnaire (P8738 F02; in Dutch)
• results of the pre-study laboratory tests
• Males aged ≥ 18 and ≤ 45 years at Day 01 of the study
• Body Mass Index (BMI): for the lean : ≥ 20 and ≤ 25 kg/m2; obese ≥ 30 and ≤ 35 kg/m2
• Normal Dutch eating habits as assessed by P8738 F02
• Voluntary participation
• Having given written informed consent
• Willing to comply with the study procedures
• Appropriate veins for blood sampling/cannula insertion according to TNO
• Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
• Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.

You may not qualify if:

• Subjects with one or more of the following characteristics will be excluded from participation:
• Participation in any clinical trial including blood sampling and/or administration of substances up to 30-90 days before Day 01 of this study
• Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalator administration of substances
• Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease or hypertension, stomach and intestinal complaints (and medication), pre-diabetes and Diabetes Mellitus
• Having stomach and/or intestinal complaints after consumption of a high-fat meal
• Usage of NSAIDs and/or acetylsalicylic acid (for example ibuprofen, diclofenac, naproxen or aspirin)
• Smoking
• Alcohol consumption ( \> 28 units/week)
• Reported unexplained weight loss or gain of \> 2 kg in the month prior to the pre-study screening
• Reported slimming or medically prescribed diet
• Recent blood donation (\<1 month prior to the start of the study)
• Not willing to give up blood donation during the study.
• Personnel of TNO Quality of Life, their partner and their first and second degree relatives
• Not having a general practitioner
• Not willing to accept information transfer, concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.

Sponsors & Collaborators

• TNO: lead
• Netherlands: Ministry of Health, Welfare and Sports: collaborator

Study Sites (1)

TNO Quality of Life

Zeist, Utrecht, 3700AJ, Netherlands

Location

Study Officials

• W J Pasman, PhD

  TNO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: July 27, 2010

Record last verified: 2010-01

Locations

NL (1)