Intestinal Permeability

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.

Inclusion criteria

• 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.

Exclusion criteria

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.