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Completed

NCT Number: NCT02946970

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

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quinine hydrochloride

Other

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

Control

Other

Intragastric administration of distilled water

Primary outcomes

  1. 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

  1. hunger scores

    Time frame: 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.

  2. Ghrelin levels

    Time frame: 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.

  3. Motilin levels

    Time frame: 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.

  4. CCK levels

    Time frame: 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.

  5. PYY levels

    Time frame: 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

  6. GLP-1 levels

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2016
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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