To investigate the effect of intraduodenal, intraileal and combined infusion of a combination of tastants versus infusion of placebo on food intake.
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Food intake during an ad libitum pasta meal in the form of a pre made lasagna.
Secondary outcome
VAS scores for satiety and GI symptoms
Background summary
The appearance of tastants in the small intestine can result in the activation
of 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. We will investigate the
effects of intraduodenal and/or intraileal infusion of a combination of
tastants (sweet (rebaudioside A), bitter (quinine) en umami (mononsodium
glutamate)) and placebo on ad libitum food intake, satiation and
gastrointestinal symptoms.
Study objective
To investigate the effect of intraduodenal, intraileal and combined infusion of
a combination of tastants versus infusion of placebo on food intake.
Study design
Single-blind randomized placebo-controlled cross-over trial in healthy
volunteers.
Intervention
Intraduodenal, intraileal or combined infusion of a combination of tastants
(sweet (rebaudioside A), bitter (quinine) and umami (monosodium glutamate)
versus infusion of placebo.
Study burden and risks
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. The catheter will remain in situ during
the remainder of the study period. Fluoroscopy will be performed during placing
as well as before and after each test day. 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 0.45 mSv (0.05 mSv x 9).
The average annual radiation a habitant of the Netherlands receives is 2.61
mSv, which is well below that of other European countries (i.e. 5.52 mSv in
Belgium) or the United States (6.2 mSv). All participants are healthy
volunteers and we don't expect any health benefits or disadvantages.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
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).
- 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
- Weight <60kg
- Non-tasters of sweet, bitter or umami
- Evidence of MSG-hypersensitivity or Chinese restaurant syndrome
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 | NL59530.068.16 |