Aim: To determine the effect of repetitive ileal brake activation on food intake, satiety, gastrointestinal peptide release (CCK, GLP-1, PYY, glucose and insulin) and gut motilityHypothesis: We hypothesize that after repetitive ileal infusion of…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in ad libitum meal intake (as measured during ad libitum pasta meal)
Secondary outcome
Difference in satiation (as measured by VAS) per time point
Measurements in plasma of the gut hormones CCK, GLP-1, PYY, insulin and glucose
Difference in gastric emptying
Difference in duodenocaecal transit time
Difference in galbladder volume
Background summary
The appearance of intact macronutrients in the small intestine induces an
intestinal brake; a negative feedback mechanism from different parts of the
intestine to the stomach, the small intestine and to the central nervous
system. These processes inhibit food processing, appetite sensations and food
intake, and furthermore they increase feelings of satiety and satiation.
Several studies showed that intraileal infusion of nutrients resulted in a
reduction in food intake. However only acute effects were investigated in these
studies and thus far it is not know whether repetitive (intermittent) infusion
results in adaptation to repeated exposure and, thus, a lowered ileal brake
response.
Therefore the current study aims to investigate the effect of repetitive ileal
brake activation on food intake, satiety, gastrointestinal peptide release
(CCK, GLP-1, PYY, glucose and insulin) and gut motility (gastric emptying,
gallbladder volume and orocaecal transit time). In this study we will infuse
casein (intervention group) or tap water (placebo group) into the ileum of
healthy volunteers. This will be done on 4 consecutive days (Tuesday,
Wednesday, Thursday and Friday) so that we are able to elucidate the effect of
repetitive ileal brake activation.
Study objective
Aim: To determine the effect of repetitive ileal brake activation on food
intake, satiety, gastrointestinal peptide release (CCK, GLP-1, PYY, glucose and
insulin) and gut motility
Hypothesis: We hypothesize that after repetitive ileal infusion of casein,
ileal brake activation on day 4 results in a similar reduction in food intake
compared to test day 1.
Primary objective: To investigate the effect of repetitive ileal infusion on ad
libitum food intake
Study design
Explorative, randomized, double blind, placebo controlled study
Intervention
Infusing casein into the ileum
Study burden and risks
Blood sampling: on each test day (test day 1-4), after the positioning of the
nasoileal catheter by fluoroscopy, a flexible intravenous cannula (Biovalve
1,0mm) is inserted into an antecubital vein in the fore-arm for blood sampling.
Per time point 8mL of blood is drawn, totalling 72mL per test day (with a total
of 288mL for the 4 test days). After collection (immediately after collection
DPP-IV inhibitor will be added to the tube), K2EDTA tubes will be centrifuged
at 2500 rpm for 10 min at 4°C. The supernatant will be collected and this will
be centrifuged again at 4000 rpm for 10 min at 4°C. Plasma will be collected in
1-mL aliquots and stored at -80°C until analysis. During blood sampling, the
volunteers will remain seated in a comfortable chair, with an adjustable back.
No side effects are expected when sampling blood in this manner.
VAS scores for satiety and GI symptoms Scores for satiety feelings (e.g.,
satiety, fullness, hunger, prospective feeding, desire to eat, desire to snack)
and gastrointestinal symptoms (burning, bloating, belching, cramps, colics,
warm sensation, sensation of abdominal fullness, nausea and pain) will be
measured using Visual Analogue Scales (VAS, 0 to 100 mm) anchored at the low
end with the most negative or lowest intensity feelings (e.g., extremely
unpleasant, not at all), and with opposing terms at the high end (e.g.,
extremely pleasant, very high, extreme). Volunteers will be asked to indicate
on a line which place on the scale best reflects their feeling at that moment.
The scoring forms will be collected immediately so that they cannot be used as
a reference for later scorings.
Catheter placing and fluoroscopy: The subjects will perceive mild discomfort
during the placement of the catheter. Each test week starts with inserting a
nasoileal tube. The radiation exposure during the positioning of the feeding
tube is minimal (0.05 mSv). The total exposure to radiation (during all test
days) will be approximately 0.20 mSv (0.05 mSv x 4) , which equals the
radiation, which is received during 2 return flight from Amsterdam to Sydney in
an aeroplane at a 4-km altitude (www.nrg- nl.com). Since the catheter will be
in situ for 4 days and this can result in minor discomfort. Subjects can, at
any time, come in contact with the investigator if any problems occur. All
participants are healthy volunteers and we don't expect any health benefits or
disadvantages.
Universiteitssingel 40
Maastricht 6229ER
NL
Universiteitssingel 40
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
• Based on medical history and previous examination, no gastrointestinal complaints can be defined.
• Age between 18 and 65 years. This study will include healthy adult subjects (male and female). Women must be taking oral contraceptives.
• BMI between 18 and 25 kg/m2)
• Weight stable over at least the last 6 months
Exclusion criteria
• History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
• Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
• Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
• Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
• Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
• Pregnancy, lactation
• Excessive alcohol consumption (>20 alcoholic consumptions per week)
• Smoking
• Blood donation within 3 months before the study period
• Self-admitted HIV-positive state
• Evidence of casein or hypersensitivity
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 | NL50301.068.14 |