Clinical trial NCT02946970: Brain Responses to Intragastric Administration of a Bitter Agonist in Homeostatic and Hedonic Brain Regions
Official title: Brain Responses to Intragastric Administration of a Bitter Agonist in Homeostatic and Hedonic Brain Regions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators aim to study the brain mechanisms underlying the effect of subliminal (not consciously perceived) intragastric administration of bitter tastants on hunger and food intake, which was previously found. The investigators will assess brain activation patterns after an acute intragastric administration of Quinine-hydrochloride versus saline on two different test days, and will simultaneously assess a putative role of altered gut peptide release in these effects. The hypothesis is that intragastric infusion of a bitter agonist will decrease the activity in homeostatic and hedonic brain regions and that this effect is mediated by gut peptide release.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Female
* N = 15
* Age 18 - 60
* Body Mass Index (BMI) of 20 - 25 kg/m
* Stable body weight for at least 3 months prior to the start of the study

Exclusion Criteria:

* Abdominal or thoracic surgery. Exception: appendectomy
* Gastrointestinal, endocrine or neurological diseases
* Cardiovascular, respiratory, renal or urinary diseases
* Hypertension
* Food or drug allergies
* Anemia
* Eating disorders and people who show abnormal eating behavior
* Depressive disorders
* Psychotic disorders
* No medication on a regular basis, expect for oral contraception
* Conditions that can interfere with functional magnetic resonance imaging (fMRI), e.g. cochlear implants, metal fragments or metal implants in the body, pacemaker, neural stimulator, ...
* No history of cannabis use or any other drug of abuse for at least 12 months prior to the study
* Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
* Dieters
* Pregnant or breastfeeding women
* Claustrophobia

Primary outcomes:
measure: Functional brain images
timeFrame: From the start of the study until 50 minutes after the start of the study
Secondary outcomes:
measure: hunger scores
timeFrame: every 10 minutes since the scan starts until until 50 minutes after the start of the scan
measure: Ghrelin levels
timeFrame: every 10 min since the scan starts until 50 minutes after the start of the scan.
measure: Motilin levels
timeFrame: every 10 min since the scan starts until 50 minutes after the start of the scan
measure: CCK levels
timeFrame: every 10 min since the scan starts until 50 minutes after the start of the scan
measure: PYY levels
timeFrame: every 10 min since the scan starts until 50 minutes after the start of the scan
measure: GLP-1 levels
timeFrame: every 10 min since the scan starts until 50 minutes after the start of the scan
Other outcomes:
Locations:
Study officials:
affiliation: University of Leuven
name: Jan Tack, Prof
role: PRINCIPAL_INVESTIGATOR
References: