HealthyNCT03447561
The Role of Consumption and Anticipation in Dopamine Release to Food Reward
A study testing Anticipatory + consummatory food reward and Consummatory food reward in people with Healthy and Food Reward, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Food Reward
- What is being tested?
- Anticipatory + consummatory food reward and Consummatory food reward
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Feb 2018to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy females (on hormonal contraception)
- Dutch-speaking
- Right-handed
- Stable body weight with Body Mass Index (BMI) of 18.5 - 25 kg/m^2
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitaire ziekenhuizen Leuven
Leuven, 3000
About this study
Official title: The Role of Consumption and Anticipation in Dopamine Release to Food Reward: an [18F]-Fallypride PET/MR Study.
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.
Read the 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.
- Conditions
- Healthy, Food Reward
- Being tested
- Anticipatory + consummatory food reward, Consummatory food reward
- Keywords
- Dopamine, Food, Reward, Anticipatory, Consummatory, Positron Emission Tomography, Magnetic Resonance, Metabolic hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticipatory + consummatory food rewardBehavioural
Exposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake).
Consummatory food rewardBehavioural
Exposure to consummatory food reward (drinking sips of chocolate milkshake).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Consummatory food reward |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dopamine release to combined vs consummatory food reward
Changes in [18F]-Fallypride binding potential (reflecting dopamine release) in the food reward condition
Measured: Continuously over 225 minutes after onset scanning
Secondary outcomes (3)
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).
Measured: 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
Correlation between dopamine response to food reward and the amount of milkshake consumed during the drink test
Measured: 230 minutes after onset of scanning (immediately following end of scanning)
Temperament and Character Inventory questionnaire
Correlation between dopamine response to food reward and scores on the Temperament and Character Inventory questionnaire.
Measured: baseline, dopamine release measured 225 minutes following onset scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start8 Feb 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Van Oudenhove, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Lukas Van Oudenhove, Prof. dr., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447561
- Sponsor's protocol ID
- S60362-h
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2018
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Consumption and Anticipation in Dopamine Release to Food Reward: an [18F]-Fallypride PET/MR Study.
- ClinicalTrials.gov ID
- NCT03447561
- Acronym / sponsor ID
- S60362-h
- Conditions
- Healthy, Food Reward
- Keywords
- Dopamine, Food, Reward, Anticipatory, Consummatory, Positron Emission Tomography, Magnetic Resonance, Metabolic hormones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Anticipatory + consummatory food reward | Experimental | Behavioral: Anticipatory + consummatory food rewardPET-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). |
| Consummatory food reward | Experimental | Behavioral: Consummatory food rewardPET-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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy females (on hormonal contraception)
- Dutch-speaking
- Right-handed
- Stable body weight with Body Mass Index (BMI) of 18.5 - 25 kg/m^2
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticipatory + consummatory food rewardExposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake). | Behavioural | Anticipatory + consummatory food reward |
| Consummatory food rewardExposure to consummatory food reward (drinking sips of chocolate milkshake). | Behavioural | Consummatory food reward |
Primary outcome
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
3 secondary outcomes
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
Amount of milkshake consumed during drink test
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Van Oudenhove, Prof. dr. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticipatory + consummatory food reward and Consummatory food reward in people with Healthy and Food Reward, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukas Van Oudenhove, Prof. dr. (003216330147, lukas.vanoudenhove@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dopamine release to combined vs consummatory food reward (time frame: Continuously over 225 minutes after onset scanning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.