The effect of a high-fat breakfast on intestinal permeability will be examined in lean and obese men to see if a fat load can induce increased intestinal permeability and it is a feasible challenge test to investigate effects of foods / ingredients…
ID
Source
Brief title
Condition
- Other condition
- Malabsorption conditions
Synonym
Health condition
darmdoorlaatbaarheid wordt gemeten in gezonde mannen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Trait Anxiety inventory (baseline stress level as a character trait).
Body resistance in relation with intestinal permeability.
Background summary
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, lipopolysaccaride (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 objective
The effect of a high-fat breakfast on intestinal permeability will be examined
in lean and obese men to see if a fat load can induce increased intestinal
permeability and it is a feasible challenge test to investigate effects of
foods / ingredients on intestinal permeability. Methods and candidate
biomarkers to investigate intestinal permeability are the main focus of the
study.
Study design
The study is designed as a randomized, cross-over and open study.
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.
Study burden and risks
Healthy lean and obese men will participate in a study to examine the
difference in acute intestinal permeability due to body weight differences.
Lean and obese subjects might represent a range in physiological homeostasis,
with the obese being representatives with a physiological condition in whom
less flexibility to challenges are expected. On one of the test days subjects
will be given an oral fat load as a nutritional challenge test. The effect of
this challenge on the intestinal permeability is determined. Subjects will
visit TNO twice for a test day of seven hours and twice for return of collected
urine. Blood samples will be drawn frequently (nine times on a test day). Urine
will be collected for 24 hours. No risk or real burden is of concern in this
study.
Gedelegeerd sponsor BU Biosciences, PO Box 360
3700 AJ Zeist
Nederland
Gedelegeerd sponsor BU Biosciences, PO Box 360
3700 AJ Zeist
Nederland
Listed location countries
Age
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/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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30957.028.09 |