Pleasure for Food and Endocannabinoids in Obesity

NCT01985139 | Completed

• 2 other identifiers: C13-332013-A00982-43
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity

Keywords

Obesity, food pleasure, behavioral tasks, endocannabinoids

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)

• Circulating endocannabinoids concentrations

  Determined on blood samples collected during the experimental sessions under fasting and satiety (days 4 and 7 after inclusion)

Study Arms (2)

Obese patients

EXPERIMENTAL

Computer-based tasks evaluating size and time discrimination capacities Blood sampling for the determination of plasma endocannabinoids levels

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

Behavioral: Computer-based tasks; Biological: Blood sampling

Interventions

Computer-based tasks BEHAVIORAL

Computer-based tasks designed to assess size and time discrimination capacities

Normal-weight healthy volunteers; Obese patients

Blood sampling BIOLOGICAL

Blood drawn for the measurement of circulating endocannabinoids concentrations

Normal-weight healthy volunteers; Obese patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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 :
• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Neurocentre Magendie (INSERM U862)

Bordeaux, 33077, France

Location

MeSH Terms

Conditions

Obesity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Bruno Aouizerate, Professor

  Neurocentre Magendie (INSERM U862)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 15, 2013
• Study Start: January 1, 2014
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

FR (1)