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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.

Descripción general del estudio

Estado

Desconocido

Condiciones

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Bordeaux, Francia, 33077
        • Reclutamiento
        • Neurocentre Magendie (INSERM U862)
        • Contacto:
        • Investigador principal:
          • Bruno Aouizerate, Professor
        • Sub-Investigador:
          • Antoine Tabarin, Professor
        • Sub-Investigador:
          • Blandine Gatta-Cherifi, Professor
        • Sub-Investigador:
          • Camille Gouzien, Doctor

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 60 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Poner en pantalla
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Experimental: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in the Point of subjective equality (PSE)
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in the Percentage of subjective discrimination (PSD)
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2014

Finalización primaria (Anticipado)

1 de febrero de 2016

Finalización del estudio (Anticipado)

1 de febrero de 2016

Fechas de registro del estudio

Enviado por primera vez

4 de noviembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

8 de noviembre de 2013

Publicado por primera vez (Estimar)

15 de noviembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de febrero de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

23 de febrero de 2016

Última verificación

1 de febrero de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • C13-33
  • 2013-A00982-43 (Identificador de registro: IDRCB)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Computer-based tasks

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