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Clinical Trials/NCT02946970
NCT02946970CompletedNot Applicable

Brain Responses to Intragastric Administration of a Bitter Agonist in Homeostatic and Hedonic Brain Regions

Universitaire Ziekenhuizen KU Leuven0 sites15 target enrollmentStarted: September 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Primary Endpoint
Functional brain images

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Healthy volunteers
  • •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
  • •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)
  • •Pregnant or breastfeeding women
  • •Claustrophobia

Arms & Interventions

Quinine hydrochloride

Experimental

Intragastric infusion

Intervention: Quinine hydrochloride (Other)

Control

Placebo Comparator

Intragastric infusion

Intervention: Control (Other)

Outcomes

Primary Outcomes

Functional brain images

Time Frame: From the start of the study until 50 minutes after the start of the study

Change in brain responses after administration compared to baseline will be assessed via functional magnetic resonance imaging.

Secondary Outcomes

  • Ghrelin levels(every 10 min since the scan starts until 50 minutes after the start of the scan.)
  • Motilin levels(every 10 min since the scan starts until 50 minutes after the start of the scan)
  • CCK levels(every 10 min since the scan starts until 50 minutes after the start of the scan)
  • PYY levels(every 10 min since the scan starts until 50 minutes after the start of the scan)
  • GLP-1 levels(every 10 min since the scan starts until 50 minutes after the start of the scan)
  • hunger scores(every 10 minutes since the scan starts until until 50 minutes after the start of the scan)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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