The Role of Consumption and Anticipation in Dopamine Release to Food Reward

February 26, 2018 updated by: Lukas Van Oudenhove, Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Universitaire Ziekenhuizen Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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).
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).
Behavioral: Consummatory food reward
Exposure to consummatory food reward (drinking sips of chocolate milkshake).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S60362-h

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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