- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03447561
The Role of Consumption and Anticipation in Dopamine Release to Food Reward
The Role of Consumption and Anticipation in Dopamine Release to Food Reward: an [18F]-Fallypride PET/MR Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The brain's reward system has a potent contribution to the regulation of food intake. Although animal work has demonstrated a key role of the mesolimbic dopamine system in food reward responses, evidence in humans is still sparse and inconsistent. Our research group recently used state-of-the-art Positron Emission Tomography (PET) imaging methods to study in vivo dopamine release in response to a combination of anticipatory (viewing high-calorie food images) and consummatory (drinking sips of chocolate milkshake) food stimuli in healthy women. The investigators demonstrated dopamine release in reward-related regions in the prefrontal cortex of the brain in response to these stimuli, correlating with levels of gastrointestinal hunger/satiety hormones, and predicting subsequent food intake.
The current 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. Healthy females will participate in two PET-MR scan sessions in a fasted state: one session with the combination of anticipatory (viewing high-calorie food images) and consummatory reward (drinking sips of chocolate milkshake) and one session with purely consummatory reward. The order of these sessions will be randomized and counterbalanced.
Both scan sessions 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' and the fourth block the 'food reward condition'. At the end of each scan session, participants will take part in an ad libitum drink test in which they will be instructed to drink as much chocolate milkshake as preferred, until comfortably full. During both sessions, blood samples will be collected at several time points to assess levels of metabolic hormones and their relation to food-induced dopamine release. The proposed studies aims to increase our understanding of the psycho-biology of appetite and food intake regulation as well as identify potential new treatment targets for disorders of food intake, both at the level of the gastrointestinal tract and the brain.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Leuven, Belgium, 3000
- Recruiting
- Universitaire Ziekenhuizen Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy females (on hormonal contraception)
- Dutch-speaking
- Right-handed
- Stable body weight with Body Mass Index (BMI) of 18.5 - 25 kg/m^2
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Anticipatory + consummatory food reward
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).
|
Exposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake).
|
|
EXPERIMENTAL: Consummatory food reward
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).
|
Exposure to consummatory food reward (drinking sips of chocolate milkshake).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dopamine release to combined vs consummatory food reward
Time Frame: Continuously over 225 minutes after onset scanning
|
Changes in [18F]-Fallypride binding potential (reflecting dopamine release) in the food reward condition
|
Continuously over 225 minutes after onset scanning
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite measure of Metabolic hormone levels
Time Frame: 5 minutes before onset scanning and 45, 105, 165, 180, 195, 210 and 225 minutes after onset scanning
|
Correlation between dopamine response to food reward and (changes in) metabolic hormone levels (ghrelin, motilin, glucagon-like peptide 1, peptide tyrosine tyrosine, leptin, and insulin).
|
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
Time Frame: 230 minutes after onset of scanning (immediately following end of scanning)
|
Correlation between dopamine response to food reward and the amount of milkshake consumed during the drink test
|
230 minutes after onset of scanning (immediately following end of scanning)
|
|
Temperament and Character Inventory questionnaire
Time Frame: baseline, dopamine release measured 225 minutes following onset scanning
|
Correlation between dopamine response to food reward and scores on the Temperament and Character Inventory questionnaire.
|
baseline, dopamine release measured 225 minutes following onset scanning
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ratings of appetite-related sensations composite
Time Frame: 5 minutes before onset of scanning and several time-points up to 225 minutes after onset of scanning
|
Ratings of hunger, fullness, prospective food consumption, satiety, nausea, pleasantness, liking, and wanting on Visual Analogue Scales
|
5 minutes before onset of scanning and several time-points up to 225 minutes after onset of scanning
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- S60362-h
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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