To investigate the effect of oral sham feeding of and intragastric delivery of quinine (a bitter agent) versus 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.
Heart rate variability (HRV)
Background summary
The appearance of quinine (a bitter tastant) orally or in the gastro-intestinal
tract can result in a negative feedback mechanism to the central nervous
system. These processes inhibit food processing, appetite sensations and food
intake. Furthermore, they can increase feelings of satiety and satiation. We
will investigate the effects of oral sham feeding and intragastric delivery of
quinine (a bitter agent) versus placebo.
Study objective
To investigate the effect of oral sham feeding of and intragastric delivery of
quinine (a bitter agent) versus placebo on food intake.
Study design
Blinded randomized placebo-controlled cross-over trial in healthy volunteers.
Intervention
Oral sham feeding of and intragastric delivery of quinine (a bitter agent)
versus 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, pain and
relaxation/tensness) 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.
Heart rate variability (HRV) will be measured four times per test day by
placing an ECG lead on the participant.
St. Jansweg 20
Venlo 5928 RC
NL
St. Jansweg 20
Venlo 5928 RC
NL
Listed location countries
Age
Inclusion criteria
- Based on medical history and previous examination, no gastrointestinal
complaints can be defined.
- Age from 18 until 65 years. This study will include healthy adult subjects
(male and female).
- BMI from 18 until 25 kg/m2
- Bodyweight stable over at least the last 6 months (up until 5% weight change
allowed)
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 that can influence study end-points (to be discussed by
medical doctor and principal investigator), including vitamin supplementation,
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 and hysterectomy allowed, and other surgery upon
judgement of medical doctor and principle investigator)
- Dieting (medically prescribed, vegetarian, diabetic, macrobiological,
biological dynamic)
- Unwillingness to eat lasagna bolognese meal
- Pregnancy, lactation
- Excessive alcohol consumption (>20 alcoholic consumptions per week)
- Smoking
- Non-tasters of bitter
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 | NL64557.068.18 |