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Pleasure for Food and Endocannabinoids in Obesity (PLOBEC)

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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

      • Bordeaux, France, 33077
        • Recrutement
        • Neurocentre Magendie (INSERM U862)
        • Contact:
        • Chercheur principal:
          • Bruno Aouizerate, Professor
        • Sous-enquêteur:
          • Antoine Tabarin, Professor
        • Sous-enquêteur:
          • Blandine Gatta-Cherifi, Professor
        • Sous-enquêteur:
          • Camille Gouzien, Doctor

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

Obese patients :

  1. Be between 18 and 60 year-old
  2. Have a body mass index ranging from 35 to 50 kg/m2
  3. Have no previous history of surgical treatment of obesity
  4. Have received no standard intervention for obesity within the last 3 months before study
  5. Have a stable weight (variation <5%) within the last 3 months before study
  6. Have a restriction score <9 on the three-factor eating questionnaire
  7. Be free from any current and previous psychiatric disorder, such as major depression or drug abuse/dependence
  8. Understand and accept the design and constraints of the present study
  9. Be a beneficiary or member of health insurance plan
  10. Provide written consent to the study after receiving clear information

Healthy volunteers :

  1. Be between 18 and 60 year-old
  2. Be free from any current and previous psychiatric disorder, such as major depression or drug abuse/dependence
  3. Understand and accept the design and constraints of the present study
  4. Be a beneficiary or member of health insurance plan
  5. Provide written consent to the study after receiving clear information

Exclusion Criteria:

Obese patients :

  1. Suffer from monogenic obesity
  2. Take any psychotropic treatment such as anxiolytic/hypnotic drugs over the last week preceding the study
  3. Be a pregnant or nursing woman
  4. Use alcohol over the last two days preceding the study

Healthy volunteers :

  1. Suffer from any current and previous somatic or psychiatric condition
  2. Have a body mass index below 18,5 kg/m2 or above 25 kg/m2
  3. Take any psychotropic treatment such as anxiolytic/hypnotic drugs over the last week preceding the study
  4. Be a pregnant or nursing woman
  5. Use alcohol over the last two days preceding the study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Dépistage
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Obese patients
Computer-based tasks evaluating size and time discrimination capacities Blood sampling for the determination of plasma endocannabinoids levels
Computer-based tasks designed to assess size and time discrimination capacities
Blood drawn for the measurement of circulating endocannabinoids concentrations
Expérimental: Normal-weight healthy volunteers
Computer-based tasks evaluating size and time discrimination capacities Blood sampling for the determination of plasma endocannabinoids levels
Computer-based tasks designed to assess size and time discrimination capacities
Blood drawn for the measurement of circulating endocannabinoids concentrations

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in the Point of subjective equality (PSE)
Délai: 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
From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in the Percentage of subjective discrimination (PSD)
Délai: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)
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.
From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)
Circulating endocannabinoids concentrations
Délai: Determined on blood samples collected during the experimental sessions under fasting and satiety (days 4 and 7 after inclusion)
Determined on blood samples collected during the experimental sessions under fasting and satiety (days 4 and 7 after inclusion)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Bruno Aouizerate, Professor, Neurocentre Magendie (INSERM U862)

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2014

Achèvement primaire (Anticipé)

1 février 2016

Achèvement de l'étude (Anticipé)

1 février 2016

Dates d'inscription aux études

Première soumission

4 novembre 2013

Première soumission répondant aux critères de contrôle qualité

8 novembre 2013

Première publication (Estimation)

15 novembre 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

24 février 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 février 2016

Dernière vérification

1 février 2016

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • C13-33
  • 2013-A00982-43 (Identificateur de registre: IDRCB)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Computer-based tasks

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