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

NCT02946970 | Completed

• 1 other identifier: S57915
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Functional brain images

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

  From the start of the study until 50 minutes after the start of the study

Secondary Outcomes (6)

• hunger scores

  every 10 minutes since the scan starts until until 50 minutes after the start of the scan

• 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

Study Arms (2)

Control

PLACEBO COMPARATOR

Intragastric infusion

Other: Control

Quinine hydrochloride

EXPERIMENTAL

Intragastric infusion

Other: Quinine hydrochloride

Interventions

Quinine hydrochloride OTHER

Intragastric administration of a bitter tastant agonist (10 μmol/kg quinine-hydrochloride)

Quinine hydrochloride

Control OTHER

Intragastric administration of distilled water

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Interventions

Quinine

Intervention Hierarchy (Ancestors)

Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jan Tack, Prof

  University of Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: October 27, 2016
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share