NCT03447561

Brief Summary

This study aims to disentangle the relative contribution of the anticipatory (food images) versus consummatory (food administration) component of dopamine release to food reward, by performing simultaneous Positron Emission Tomography (PET) and Magnetic Resonance (MR) scanning. Additionally, this study aims to assess the relationship of the dopamine release with (changes in) metabolic hormone levels.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 8, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

February 8, 2018

Last Update Submit

February 26, 2018

Conditions

Keywords

DopamineFoodRewardAnticipatoryConsummatoryPositron Emission TomographyMagnetic ResonanceMetabolic hormones

Outcome Measures

Primary Outcomes (1)

  • Dopamine release to combined vs consummatory food reward

    Changes in \[18F\]-Fallypride binding potential (reflecting dopamine release) in the food reward condition

    Continuously over 225 minutes after onset scanning

Secondary Outcomes (3)

  • Composite measure of Metabolic hormone levels

    5 minutes before onset scanning and 45, 105, 165, 180, 195, 210 and 225 minutes after onset scanning

  • Amount of milkshake consumed during drink test

    230 minutes after onset of scanning (immediately following end of scanning)

  • Temperament and Character Inventory questionnaire

    baseline, dopamine release measured 225 minutes following onset scanning

Other Outcomes (1)

  • Ratings of appetite-related sensations composite

    5 minutes before onset of scanning and several time-points up to 225 minutes after onset of scanning

Study Arms (2)

Anticipatory + consummatory food reward

EXPERIMENTAL

PET-MR scan session with a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake). This scan session will consist of four blocks with a duration of 45 minutes each and 15 minute breaks in between. The first three blocks represent the 'control condition' (viewing neutral images and drinking sips of water) and the fourth block the 'food reward condition' (viewing high-calorie food images and drinking sips of chocolate milkshake).

Behavioral: Anticipatory + consummatory food reward

Consummatory food reward

EXPERIMENTAL

PET-MR scan session with purely consummatory food reward (drinking sips of chocolate milkshake). This scan session will consist of four blocks with a duration of 45 minutes each and 15 minute breaks in between. The first three blocks represent the 'control condition' (drinking sips of water) and the fourth block the 'food reward condition' (drinking sips of chocolate milkshake).

Behavioral: Consummatory food reward

Interventions

Exposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake).

Anticipatory + consummatory food reward

Exposure to consummatory food reward (drinking sips of chocolate milkshake).

Consummatory food reward

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy females (on hormonal contraception)
  • Dutch-speaking
  • Right-handed
  • Stable body weight with Body Mass Index (BMI) of 18.5 - 25 kg/m\^2

You may not qualify if:

  • Medical, neurological or psychiatric disorders
  • Use of psychotropic medication in past 6 months
  • Use of cannabis or other drugs of abuse in past 12 months
  • Lactose-intolerance or food allergies
  • Vegetarian diet
  • Smoking
  • Consumption of more than 7 alcoholic units per week
  • Exposure to a significant amount of ionizing radiation in past 12 months
  • Claustrophobia
  • Contra-indications for Magnetic Resonance Imaging
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaire ziekenhuizen Leuven

Leuven, 3000, Belgium

RECRUITING

Study Officials

  • Lukas Van Oudenhove, Prof. dr.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Van Oudenhove, Prof. dr.

CONTACT

Danielle Jongen, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: All participants will receive one PETMR scan session with the combination of anticipatory (viewing high-calorie food images) and consummatory reward (drinking sips of chocolate milkshake), and one PETMR scan session with purely consummatory reward, in a randomized and counterbalanced order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 27, 2018

Study Start

February 8, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations