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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03447561
Other study ID # S60362-h
Secondary ID
Status Recruiting
Phase N/A
First received February 8, 2018
Last updated February 26, 2018
Start date February 8, 2018
Est. completion date June 2019

Study information

Verified date February 2018
Source Universitaire Ziekenhuizen Leuven
Contact Lukas Van Oudenhove, Prof. dr.
Phone 003216330147
Email lukas.vanoudenhove@kuleuven.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium Universitaire ziekenhuizen Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other Ratings of appetite-related sensations composite 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
Primary 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 Composite measure of Metabolic hormone levels 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
Secondary Amount of milkshake consumed during drink test 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)
Secondary Temperament and Character Inventory questionnaire 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
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