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

NCT ID: NCT02946970

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Intragastric infusion

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Intragastric administration of distilled water

Quinine hydrochloride

Intragastric infusion

Group Type EXPERIMENTAL

Quinine hydrochloride

Intervention Type OTHER

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

Interventions

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Quinine hydrochloride

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

Intervention Type OTHER

Control

Intragastric administration of distilled water

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Tack, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Leuven

Other Identifiers

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S57915

Identifier Type: -

Identifier Source: org_study_id