Primary Objective: To determine oral, gastric and duodenal lipid degradation of fat preloads .Secondary Objectives: To study how the oro-gastro-intestinal digestion of these fat preloads relates to: - Colloidal stability. For this we will monitor…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint
The main study parameter is the amount of fatty acids released after an
intragastric fat load of well-emulsified fat
Secondary outcome
The secondary parameters are;
- Differences in fatty acid release between an intragastric load of
non-emulsified vs. well-emulsified fat
- Differences in fatty acid release after oral vs. gastric vs. duodenal
administration of well-emulsified fat
- Colloidal behaviour (droplet size, flocculation, aggregation, coalescence) in
the oral, gastric and duodenal compartment
- Lipase activity
- Gastric emptying, small bowel transit time
- Gut hormones: hormones CCK (blood), GLP-1 (blood) ,PYY (blood en saliva),
ghrelin (blood and saliva)
- Satiety: VAS (visual analogue scale)
- Energy intake at a subsequent meal
- Gallbladder motility/ emptying
Background summary
Interaction of fat with the mouth, stomach and intestines will trigger
physiological responses that will have impact on the (further) digestion, gut
transit time and absorption of the fat. Moreover, these responses will also
influence and contribute toward regulation of food intake and satiety.
No systematic research has been carried out on understanding how the
physicochemical properties of foods affect the digestion and absorption of
lipids. Previous studies have shown that the release of free fatty acids
triggers the fat-related physiological responses. We hypothesize that the
release of fatty acids is dependent of the colloidal state of the fat, which
changes progressively due to the pH-changes and enzymatic activities in the
mouth, stomach and intestines.
Study objective
Primary Objective:
To determine oral, gastric and duodenal lipid degradation of fat preloads .
Secondary Objectives:
To study how the oro-gastro-intestinal digestion of these fat preloads relates
to:
- Colloidal stability. For this we will monitor changes in colloidal behaviour
(droplet size, flocculation, aggregation, coalescence) in samples from the
oral, gastric and duodenal compartment
- Physiological responses. For this, we will determine the gastric emptying
rate and small bowel transit time of the ingested emulsion systems. Furthermore
we will measure gallbladder motility and we will investigate the effect of the
ingested emulsion on food intake, postprandial satiety and hormone release.
Study design
Randomised single blinded cross over design
Intervention
Application of a well- vs non-emulsified fat drink in the stomach or duodenum
or oral ingestion of the drink.
Study burden and risks
Subjects will have to undergo an overnight fasting period of 8 hours. This
implies no burden to the subject.
During the test day, insertion of the nasogastric duodenal feeding catheter
will take place. There is a very small risk of bowel perforation, but no
literature is available on the actual risk. This risk is generally considered
as nihil. The subjects will perceive mild discomfort during the placement of
the catheter. The radiation exposure during the positioning of the feeding tube
is minimal. The total exposure to radiation will be approximately 0.06 mSv,
which equals the radiation which is received during a one-hr flight in an
aeroplane at a 4-km altitude (www.nrg-nl.com).
The insertion of intravenous cannulae is a safe, routinely used technique in
daily clinical practice and could cause blue spots. Breath and saliva sampling
and echoscopy measurements are not associated with any risks
P.O. Box 616
6200 MD
Nederland
P.O. Box 616
6200 MD
Nederland
Listed location countries
Age
Inclusion criteria
Sex: male and female
age: 18-55 years
BMI: 18-29kg/m2
Exclusion criteria
Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/ connective tissue, musculoskeletal, metabolic/nutritional, endocrine, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol
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 | NL29754.068.09 |