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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Control; Other: Quinine hydrochloride

• Registration Number: NCT02946970
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-05
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-10-26
• Last Update Submitted: 2016-10-26
• Study First Posted: 2016-10-27
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Control	Intragastric infusion
Quinine hydrochloride	Quinine hydrochloride	Intragastric infusion

Primary Outcome Measures

Name	Time	Method
Functional brain images	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 Outcome Measures

Name	Time	Method
Ghrelin levels	every 10 min since the scan starts until 50 minutes after the start of the scan.	Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure ghrelin levels by radioimmuno-assay.
Motilin levels	every 10 min since the scan starts until 50 minutes after the start of the scan	Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure motilin levels by radioimmuno-assay.
CCK levels	every 10 min since the scan starts until 50 minutes after the start of the scan	Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure CCK levels by radioimmuno-assay.
PYY levels	every 10 min since the scan starts until 50 minutes after the start of the scan	Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure PYY levels by Enzyme-Linked Immuno Sorbent Assay
GLP-1 levels	every 10 min since the scan starts until 50 minutes after the start of the scan	Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure GLP-1 levels by Enzyme-Linked Immuno Sorbent Assay
hunger scores	every 10 minutes since the scan starts until until 50 minutes after the start of the scan	The hunger scores will be taken every 10 minutes since the scan starts via a 10 cm visual analogue scale.