Bulimia NervosaNCT03471806
Dopamine Release to Food Reward in Bulimia Nervosa
A study testing Food reward at baseline and Food reward after treatment in people with Bulimia Nervosa and Food Reward, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This study will assess the role of dopamine responses to food reward in Bulimia Nervosa patients, by performing simultaneous Positron Emission Tomography (PET) and Magnetic Resonance (MR) scanning. The dopamine response will be measured before and after treatment, and will be compared to healthy controls. 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
- Bulimia Nervosa, Food Reward
- What is being tested?
- Food reward at baseline and Food reward after treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Feb 2018to May 2020
- 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
- Diagnosed with Bulimia Nervosa based on DSM-5 criteria;
- Admission for inpatient treatment;
- Female (on hormonal contraception);
- Dutch-speaking;
- Right-handed;
- Body Mass Index (BMI) of 18.5 - 25 kg/m².
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- Healthy females (on hormonal contraception);
- Dutch-speaking;
- Right-handed;
- Stable body weight with BMI of 18.5 - 25 kg/m².
- Additional Exclusion Criteria:
- Any psychiatric disorders;
- Emotional or restraint eating behaviour.
Who cannot join
- Medical, neurological or other 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;
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- 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.
- Healthy control participants:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dopamine Release to Food Reward in Bulimia Nervosa: an [18F]-Fallypride PET/MR Study.
This study will assess the role of dopamine responses to food reward in Bulimia Nervosa patients, by performing simultaneous Positron Emission Tomography (PET) and Magnetic Resonance (MR) scanning. The dopamine response will be measured before and after treatment, and will be compared to healthy controls.
Read the detailed description
Bulimia nervosa is a psychiatric eating disorder characterized by recurrent episodes of binge eating, followed by inappropriate compensatory behaviour. It is associated with a high disease burden and high rates of medical and psychiatric comorbidities. Only 50% of patients achieve long-term remission, indicating the need for a better understanding of the pathophysiology which can guide the development of new treatment options.
There are strong indications for an involvement of the brain's dopaminergic reward system in Bulimia Nervosa, such as the presence of elevated craving for rewarding food and poorer impulse control. However, there is no clear evidence on the exact involvement of the reward system nor direct evidence of abnormal dopamine responses to food reward. Therefore, the current study will assess dopamine release and related brain activity to food reward in Bulimia Nervosa patients, by performing simultaneous Positron Emission Tomography (PET) and Magnetic Resonance (MR) scanning. Specifically, the investigators will compare dopamine release in Bulimia Nervosa patients to healthy controls, and assess the effect of successful treatment on the food reward response. To this end, 20 Bulimia Nervosa patients will participate in one PET-MR scan before the start of inpatient treatment and in a second PET-MR scan at the end of inpatient treatment. Additionally, PET-MR scans will be obtained from a group of 20 healthy control participants.
All scan session will measure dopamine release to a combination of anticipatory (viewing high-calorie food images) and consummatory (drinking sips of chocolate milkshake) food reward and will be conducted in a fasted state. The 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'. 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.
This study aims to improve our understanding of the disease process underlying Bulimia Nervosa and to enable the identification of new and specific treatment targets at multiple levels of the gut-brain axis, including the dopamine system in the brain but also metabolic hormones and the interactions between both. Additionally, the results may have the potential to guide the optimisation of behavioural treatment approaches with a stronger focus on aberrant reward system responses.
- Conditions
- Bulimia Nervosa, Food Reward
- Being tested
- Food reward at baseline, Food reward after treatment
- Keywords
- Bulimia Nervosa, Eating disorder, Dopamine, Food, Reward, Positron Emission Tomography, Magnetic Resonance, Metabolic hormones
- Medical subject headings
- Bulimia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food reward at baselineBehavioural
Exposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake), at baseline.
Food reward after treatmentBehavioural
Exposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake), at the end of inpatient treatment.
| Study group | Role | What they receive |
|---|---|---|
| Bulimia Nervosa patients | Experimental | Bulimia Nervosa patient group: Assessment of dopamine release to food reward at baseline (before treatment) and to food reward after treatment. Receives: Behavioral: Food reward at baseline; Behavioral: Food reward after treatment |
| Healthy controls | Experimental | Healthy control group: Assessment of dopamine release to food reward at baseline, for comparison with Bulimia Nervosa patients. Receives: Behavioral: Food reward at baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dopamine release to food reward in Bulimia Nervosa patients compared to healthy controls
Comparison of dopamine release to food reward between Bulimia Nervosa patients and healthy controls. Dopamine release is defined as changes in [18F]-Fallypride binding potential in the food reward condition, with a kinetic linearized simplified reference region model (LSSRM) model.
Measured: Continuously over 225 minutes after onset scanning; at baseline (before onset treatment of patients)
Change in dopamine release to food reward in Bulimia Nervosa patients before and after treatment
Comparison of dopamine release to food reward before and after inpatient treatment for Bulimia Nervosa. Dopamine release is defined as changes in [18F]-Fallypride binding potential in the food reward condition, with a kinetic linearized simplified reference region model (LSSRM) model.
Measured: Continuously over 225 minutes after onset scanning; before and after inpatient treatment
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start16 Feb 2018
- Primary completionFeb 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT03471806
- Sponsor's protocol ID
- S60362-BN
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 21 Mar 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 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine Release to Food Reward in Bulimia Nervosa: an [18F]-Fallypride PET/MR Study.
- ClinicalTrials.gov ID
- NCT03471806
- Acronym / sponsor ID
- S60362-BN
- Conditions
- Bulimia Nervosa, Food Reward
- Keywords
- Bulimia Nervosa, Eating disorder, Dopamine, Food, Reward, Positron Emission Tomography, Magnetic Resonance, Metabolic hormones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 21 Mar 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 will assess the role of dopamine responses to food reward in Bulimia Nervosa patients, by performing simultaneous Positron Emission Tomography (PET) and Magnetic Resonance (MR) scanning. The dopamine response will be measured before and after treatment, and will be compared to healthy controls.
Detailed description
Bulimia nervosa is a psychiatric eating disorder characterized by recurrent episodes of binge eating, followed by inappropriate compensatory behaviour. It is associated with a high disease burden and high rates of medical and psychiatric comorbidities. Only 50% of patients achieve long-term remission, indicating the need for a better understanding of the pathophysiology which can guide the development of new treatment options.
There are strong indications for an involvement of the brain's dopaminergic reward system in Bulimia Nervosa, such as the presence of elevated craving for rewarding food and poorer impulse control. However, there is no clear evidence on the exact involvement of the reward system nor direct evidence of abnormal dopamine responses to food reward. Therefore, the current study will assess dopamine release and related brain activity to food reward in Bulimia Nervosa patients, by performing simultaneous Positron Emission Tomography (PET) and Magnetic Resonance (MR) scanning. Specifically, the investigators will compare dopamine release in Bulimia Nervosa patients to healthy controls, and assess the effect of successful treatment on the food reward response. To this end, 20 Bulimia Nervosa patients will participate in one PET-MR scan before the start of inpatient treatment and in a second PET-MR scan at the end of inpatient treatment. Additionally, PET-MR scans will be obtained from a group of 20 healthy control participants.
All scan session will measure dopamine release to a combination of anticipatory (viewing high-calorie food images) and consummatory (drinking sips of chocolate milkshake) food reward and will be conducted in a fasted state. The 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'. 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.
This study aims to improve our understanding of the disease process underlying Bulimia Nervosa and to enable the identification of new and specific treatment targets at multiple levels of the gut-brain axis, including the dopamine system in the brain but also metabolic hormones and the interactions between both. Additionally, the results may have the potential to guide the optimisation of behavioural treatment approaches with a stronger focus on aberrant reward system responses.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bulimia Nervosa patients | Experimental | Behavioral: Food reward at baseline, Behavioral: Food reward after treatmentBulimia Nervosa patient group: Assessment of dopamine release to food reward at baseline (before treatment) and to food reward after treatment. |
| Healthy controls | Experimental | Behavioral: Food reward at baselineHealthy control group: Assessment of dopamine release to food reward at baseline, for comparison with Bulimia Nervosa patients. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Diagnosed with Bulimia Nervosa based on DSM-5 criteria;
- Admission for inpatient treatment;
- Female (on hormonal contraception);
- Dutch-speaking;
- Right-handed;
Key exclusion criteria (12 listed)
- Medical, neurological or other 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 |
|---|---|---|
| Food reward at baselineExposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake), at baseline. | Behavioural | Bulimia Nervosa patients, Healthy controls |
| Food reward after treatmentExposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake), at the end of inpatient treatment. | Behavioural | Bulimia Nervosa patients |
Primary outcome
Dopamine release to food reward in Bulimia Nervosa patients compared to healthy controls
Time frame: Continuously over 225 minutes after onset scanning; at baseline (before onset treatment of patients)
Comparison of dopamine release to food reward between Bulimia Nervosa patients and healthy controls. Dopamine release is defined as changes in [18F]-Fallypride binding potential in the food reward condition, with a kinetic linearized simplified reference region model (LSSRM) model.
Change in dopamine release to food reward in Bulimia Nervosa patients before and after treatment
Time frame: Continuously over 225 minutes after onset scanning; before and after inpatient treatment
Comparison of dopamine release to food reward before and after inpatient treatment for Bulimia Nervosa. Dopamine release is defined as changes in [18F]-Fallypride binding potential in the food reward condition, with a kinetic linearized simplified reference region model (LSSRM) model.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 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 Food reward at baseline and Food reward after treatment in people with Bulimia Nervosa 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 13 inclusion and 12 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 21 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dopamine release to food reward in Bulimia Nervosa patients compared to healthy controls (time frame: Continuously over 225 minutes after onset scanning; at baseline (before onset treatment of patients)). The study lists 2 primary outcomes in all. 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 21 Mar 2018.