ObesityPLOBECNCT01985139
Pleasure for Food and Endocannabinoids in Obesity
A study testing Computer-based tasks and Blood sampling in people with Obesity, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Disturbances in hedonic and motivational processes play a major role in the pathophysiology of obesity. To date, experimental approaches for the study of emotional and motivational processing rely on subjective assessment scales. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Computer-based tasks and Blood sampling
- 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 siteFrance
- Study dates
- Jan 2014to 21 Nov 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obese patients :
- Be between 18 and 60 year-old
- Have a body mass index ranging from 35 to 50 kg/m2
- Have no previous history of surgical treatment of obesity
- Have received no standard intervention for obesity within the last 3 months before study
- Have a stable weight (variation <5%) within the last 3 months before study
Show all 17Show fewer
- Have a restriction score <9 on the three-factor eating questionnaire
- Be free from any current and previous psychiatric disorder, such as major depression or drug abuse/dependence
- Understand and accept the design and constraints of the present study
- Be a beneficiary or member of health insurance plan
- Provide written consent to the study after receiving clear information
- Healthy volunteers :
- Be between 18 and 60 year-old
- Be free from any current and previous psychiatric disorder, such as major depression or drug abuse/dependence
- Understand and accept the design and constraints of the present study
- Be a beneficiary or member of health insurance plan
- Provide written consent to the study after receiving clear information
Who cannot join
- Obese patients :
- Suffer from monogenic obesity
- Take any psychotropic treatment such as anxiolytic/hypnotic drugs over the last week preceding the study
- Be a pregnant or nursing woman
- Use alcohol over the last two days preceding the study
- Healthy volunteers :
Show all 11Show fewer
- Suffer from any current and previous somatic or psychiatric condition
- Have a body mass index below 18,5 kg/m2 or above 25 kg/m2
- Take any psychotropic treatment such as anxiolytic/hypnotic drugs over the last week preceding the study
- Be a pregnant or nursing woman
- Use alcohol over the last two days preceding the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Method for the Characterisation of Pleasure for Food in Obesity and Relationships With the Endocannabinoid System
Disturbances in hedonic and motivational processes play a major role in the pathophysiology of obesity. To date, experimental approaches for the study of emotional and motivational processing rely on subjective assessment scales. We have therefore developed two novel computer-generated tasks challenging respectively visual and temporal discrimination capacities for a quantitative and objective measurement of the hedonic and motivational state in humans. According to the task, the subjects are asked to view and to compare two stimuli, an appetitive one (food pictures) and its devalued counterpart (food pictures in greyscale), at each trial, assessing either the size (task A) or the duration of presentation (task B). From these considerations, the present project aims at using our novel tool to: i) assess the hedonic and motivational state in subjects with obesity, ii) compare their responses with healthy volunteers, and iii) establish relationships with biological markers known to be highly involved in the regulation of both emotional and motivational processes, such as endocannabinoids. The present project should demonstrate that the behavioral tests validated in our laboratory are relevant experimental tools for the diagnostic/clinical assessment and for the phenotypic characterization of obese patients. The application of the test in the therapeutic context could add further information about the efficacy and relevance of the chosen therapy. Finally, our project will provide information on the biological substrates of hedonic and motivational impairments that might become target of therapy in obesity.
Read the detailed description
Disturbances in hedonic and motivational processes play a major role in the pathophysiology of reward-related diseases, such as obesity. To date, experimental approaches for the study of emotional and motivational processing rely on subjective assessment scales. We have therefore developed and validated a novel computer-generated test challenging visual and temporal discrimination capacities in humans. The subjects are asked to view and to compare two stimuli, an appetitive one (food pictures; F) and its devalued counterpart (food pictures in greyscale; D), at each trial, assessing either the size (task A) or the duration of presentation (task B). Geometric figures are used as controls and presented in color (C) or greyscale (D). Both tasks are registered under the French agency for the protection of computer software. Here, we propose to use our novel test to: i) assess the hedonic and motivational state in subjects suffering from obesity, ii) compare their responses with healthy volunteers, and iii) establish relationships with biological markers known to be highly involved in the regulation of both emotional and motivational processes, such as endocannabinoids. Responses to the test in obese patients will be evaluated during two separate experimental sessions under either fasting or satiety conditions.
The present study is expected to begin mid-November 2013 for a total duration of 24 consecutive months. A sample of 25 patients suffering from obesity will be recruited and compared with 25 healthy normal volunteers who are free from any previous or current metabolic and psychiatric disorders. They will be matched on age and sex. They will be screened using the "Association pour la Méthodologie et la Documentation en Psychiatrie" questionnaire for obtaining a series of information, comprising the marital status, number of children, number of siblings, education and training, professional qualifications, significant life events… They will be evaluated with the Mini-International Neuropsychiatric Interview in order to determine the presence of mood disorders and associated psychopathology. The Three-Factor Eating Questionnaire will be employed for measuring three separate aspects of eating behavior: cognitive restraint, uncontrolled eating, and emotional eating. This will be completed with the Multidimensional Body Self-Relations Questionnaire and the State-Trait Anxiety Inventory in order to assess the body satisfaction and anxiety levels, respectively. Beyond all these assessments, two separate experimental sessions will be conducted, one in satiety and the other in fasting. During each session, the participants will be asked to perform the two validated instrumental tasks in front the screen of a computer. Plasma levels of endocannabinoids will be monitered by collecting blood samples prior to the consumption of a calorically-defined meal and while carrying out the computer-generated tasks under satiety. Blood will be withdrawn at the same time-points during the session in fasting. Visual analogue scales (VAS) assessing hunger levels will be completed before blood is collected. A VAS will be also used for the global assessment of appetitive properties of the viewed food images just before the end of the second experimental session.
- Conditions
- Obesity
- Being tested
- Computer-based tasks, Blood sampling
- Keywords
- Obesity, food pleasure, behavioral tasks, endocannabinoids
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based tasksBehavioural
Computer-based tasks designed to assess size and time discrimination capacities
Blood samplingBiological
Blood drawn for the measurement of circulating endocannabinoids concentrations
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Experimental | Computer-based tasks evaluating size and time discrimination capacities Blood sampling for the determination of plasma endocannabinoids levels Receives: Behavioral: Computer-based tasks; Biological: Blood sampling |
| Normal-weight healthy volunteers | Experimental | Computer-based tasks evaluating size and time discrimination capacities Blood sampling for the determination of plasma endocannabinoids levels Receives: Behavioral: Computer-based tasks; Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Point of subjective equality (PSE)
The PSE is defined as the ratio "F"/"D" or "C"/"D" for which the stimulus "F" or "C" was judged greater than "D" with a probability of 0.5
Measured: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)
Secondary outcomes (2)
Change in the Percentage of subjective discrimination (PSD)
The PSD is defined as the percentage of responses where the stimulus "F" or "C" was judged greater than "D" during the trials where the stimulus "F" or "C" was physically equal to "D", in terms of size or duration of presentation.
Measured: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)
Circulating endocannabinoids concentrations
Measured: Determined on blood samples collected during the experimental sessions under fasting and satiety (days 4 and 7 after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startJan 2014
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bruno Aouizerate, Professor, Principal investigator, Neurocentre Magendie (INSERM U862)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985139
- Sponsor's protocol ID
- C13-33
- Other IDs
- 2013-A00982-43
- Acronym
- PLOBEC
- Status last verified
- Jan 2025
- First submitted
- 4 Nov 2013
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method for the Characterisation of Pleasure for Food in Obesity and Relationships With the Endocannabinoid System
- ClinicalTrials.gov ID
- NCT01985139
- Acronym / sponsor ID
- PLOBEC / C13-33
- Conditions
- Obesity
- Keywords
- Obesity, food pleasure, behavioral tasks, endocannabinoids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Jan 2014 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 15 Nov 2013 (estimated)
- 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.
Disturbances in hedonic and motivational processes play a major role in the pathophysiology of obesity. To date, experimental approaches for the study of emotional and motivational processing rely on subjective assessment scales. We have therefore developed two novel computer-generated tasks challenging respectively visual and temporal discrimination capacities for a quantitative and objective measurement of the hedonic and motivational state in humans. According to the task, the subjects are asked to view and to compare two stimuli, an appetitive one (food pictures) and its devalued counterpart (food pictures in greyscale), at each trial, assessing either the size (task A) or the duration of presentation (task B). From these considerations, the present project aims at using our novel tool to: i) assess the hedonic and motivational state in subjects with obesity, ii) compare their responses with healthy volunteers, and iii) establish relationships with biological markers known to be highly involved in the regulation of both emotional and motivational processes, such as endocannabinoids. The present project should demonstrate that the behavioral tests validated in our laboratory are relevant experimental tools for the diagnostic/clinical assessment and for the phenotypic characterization of obese patients. The application of the test in the therapeutic context could add further information about the efficacy and relevance of the chosen therapy. Finally, our project will provide information on the biological substrates of hedonic and motivational impairments that might become target of therapy in obesity.
Detailed description
Disturbances in hedonic and motivational processes play a major role in the pathophysiology of reward-related diseases, such as obesity. To date, experimental approaches for the study of emotional and motivational processing rely on subjective assessment scales. We have therefore developed and validated a novel computer-generated test challenging visual and temporal discrimination capacities in humans. The subjects are asked to view and to compare two stimuli, an appetitive one (food pictures; F) and its devalued counterpart (food pictures in greyscale; D), at each trial, assessing either the size (task A) or the duration of presentation (task B). Geometric figures are used as controls and presented in color (C) or greyscale (D). Both tasks are registered under the French agency for the protection of computer software. Here, we propose to use our novel test to: i) assess the hedonic and motivational state in subjects suffering from obesity, ii) compare their responses with healthy volunteers, and iii) establish relationships with biological markers known to be highly involved in the regulation of both emotional and motivational processes, such as endocannabinoids. Responses to the test in obese patients will be evaluated during two separate experimental sessions under either fasting or satiety conditions.
The present study is expected to begin mid-November 2013 for a total duration of 24 consecutive months. A sample of 25 patients suffering from obesity will be recruited and compared with 25 healthy normal volunteers who are free from any previous or current metabolic and psychiatric disorders. They will be matched on age and sex. They will be screened using the "Association pour la Méthodologie et la Documentation en Psychiatrie" questionnaire for obtaining a series of information, comprising the marital status, number of children, number of siblings, education and training, professional qualifications, significant life events… They will be evaluated with the Mini-International Neuropsychiatric Interview in order to determine the presence of mood disorders and associated psychopathology. The Three-Factor Eating Questionnaire will be employed for measuring three separate aspects of eating behavior: cognitive restraint, uncontrolled eating, and emotional eating. This will be completed with the Multidimensional Body Self-Relations Questionnaire and the State-Trait Anxiety Inventory in order to assess the body satisfaction and anxiety levels, respectively. Beyond all these assessments, two separate experimental sessions will be conducted, one in satiety and the other in fasting. During each session, the participants will be asked to perform the two validated instrumental tasks in front the screen of a computer. Plasma levels of endocannabinoids will be monitered by collecting blood samples prior to the consumption of a calorically-defined meal and while carrying out the computer-generated tasks under satiety. Blood will be withdrawn at the same time-points during the session in fasting. Visual analogue scales (VAS) assessing hunger levels will be completed before blood is collected. A VAS will be also used for the global assessment of appetitive properties of the viewed food images just before the end of the second experimental session.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients | Experimental | Behavioral: Computer-based tasks, Biological: Blood samplingComputer-based tasks evaluating size and time discrimination capacities Blood sampling for the determination of plasma endocannabinoids levels |
| Normal-weight healthy volunteers | Experimental | Behavioral: Computer-based tasks, Biological: Blood samplingComputer-based tasks evaluating size and time discrimination capacities Blood sampling for the determination of plasma endocannabinoids levels |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Be between 18 and 60 year-old
- Have a body mass index ranging from 35 to 50 kg/m2
- Have no previous history of surgical treatment of obesity
- Have received no standard intervention for obesity within the last 3 months before study
- Have a stable weight (variation <5%) within the last 3 months before study
Key exclusion criteria (11 listed)
- Suffer from monogenic obesity
- Take any psychotropic treatment such as anxiolytic/hypnotic drugs over the last week preceding the study
- Be a pregnant or nursing woman
- Use alcohol over the last two days preceding the study
- Suffer from any current and previous somatic or psychiatric condition
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 |
|---|---|---|
| Computer-based tasksComputer-based tasks designed to assess size and time discrimination capacities | Behavioural | Normal-weight healthy volunteers, Obese patients |
| Blood samplingBlood drawn for the measurement of circulating endocannabinoids concentrations | Biological | Normal-weight healthy volunteers, Obese patients |
Primary outcome
Change in the Point of subjective equality (PSE)
Time frame: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)
The PSE is defined as the ratio "F"/"D" or "C"/"D" for which the stimulus "F" or "C" was judged greater than "D" with a probability of 0.5
2 secondary outcomes
Change in the Percentage of subjective discrimination (PSD)
Time frame: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)
Circulating endocannabinoids concentrations
Time frame: Determined on blood samples collected during the experimental sessions under fasting and satiety (days 4 and 7 after inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
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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.
Bruno Aouizerate, Professor principal investigator
Neurocentre Magendie (INSERM U862)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based tasks and Blood sampling in people with Obesity, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 17 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: finished, as of the sponsor's last update on 23 Jan 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the Point of subjective equality (PSE) (time frame: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)). 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 23 Jan 2025.