Methods to examine intestinal permeability under different conditions.
- Conditions
- darmdoorlaatbaarheid wordt gemeten in gezonde mannenintestinal permeabilityirretable bowel syndrome10025477
- Registration Number
- NL-OMON32575
- Lead Sponsor
- Ministerie van Volksgezondheid, Welzijn en Sport (VWS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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/canulla 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.
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 acetylsalicyl 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 & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Intestinal permeability will be examined with an absorption test using four<br /><br>different sugars (sucrose, mannitol, sucralose and lactulose). New markers of<br /><br>intestinal permeability, like I-FABP, L-FABP, LPS and inflammatory markers will<br /><br>be measured as well. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Trait Anxiety inventory (baseline stress level as a character trait).<br /><br>Body resistance in relation with intestinal permeability.</p><br>