Intestinal Permeability

July 26, 2010 updated by: TNO

Methods to Examine Intestinal Permeability Under Different Conditions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Utrecht
      • Zeist, Utrecht, Netherlands, 3700AJ
        • TNO Quality of Life

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy as assessed by the

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

Exclusion Criteria:

Subjects with one or more of the following characteristics will be excluded from participation:

  1. Participation in any clinical trial including blood sampling and/or administration of substances up to 30-90 days before Day 01 of this study
  2. 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
  3. 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
  4. Having stomach and/or intestinal complaints after consumption of a high-fat meal
  5. Usage of NSAIDs and/or acetylsalicylic acid (for example ibuprofen, diclofenac, naproxen or aspirin)
  6. Smoking
  7. Alcohol consumption ( > 28 units/week)
  8. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
  9. Reported slimming or medically prescribed diet
  10. Recent blood donation (<1 month prior to the start of the study)
  11. Not willing to give up blood donation during the study.
  12. Personnel of TNO Quality of Life, their partner and their first and second degree relatives
  13. Not having a general practitioner
  14. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sugar absorption test
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
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.
Experimental: Sugar absorption test and high-fat breakfast
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intestinal absorption (measured with the four sugar absorption test)
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Different biomarkers for intestinal absorption.
Time Frame: 6 hours
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TNO

Collaborators

Netherlands: Ministry of Health, Welfare and Sports

Investigators

  • Principal Investigator: W J Pasman, PhD, TNO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Estimate)

July 27, 2010

Last Update Submitted That Met QC Criteria

July 26, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8738

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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