Functional Magnetic Resonance Imaging (fMRI) Exploration of Neurocognitive Processes Involved in Food Addiction (FA) in Obese Patients: Towards New Phenotypic Markers for an Optimized Care Pathway

Phase 2

Completed

• Conditions: Obesity
• Interventions: Device: fMRI; Device: Indirect calorimetry; Device: Bioimpedance; Biological: Lipid profile, glucose, HBA1c, metabolomic analysis; Behavioral: YFAS questionnaire, Binge Eating Scale, Hospital Anxiety and Depression (HAD) scale, hedonic evaluation test (liking)

• Registration Number: NCT03454711
• Lead Sponsor: Rennes University Hospital

Brief Summary

Identification of the cerebral fMRI phenotype of obese patients with FA in cognitive task context based on food choice making

Detailed Description

Obesity is a worldwide epidemic associated with many complications. The treatment of obesity is a failure if it does not take into account eating disorders. Among them, food addictions seem to be frequent among obese patients. Clinical diagnosis and therapeutic approaches depend on presence of these FA. Moreover, eating disorders are associated with visible brain abnormalities in fMRI but the cerebral fMRI phenotype of FA is not known.

Study Timeline

• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-06
• Study Start: 2018-04-26
• Primary Completion: 2021-09-08
• Study Completion: 2021-09-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

Inclusion Criteria

• female
• right-handed
• grade 1 and 2 obesity
• aged between 20 and 50
• no other addictions including smoking
• no contraindications to fMRI
• affiliated to French Social Security
• having given a written informed consent

Exclusion Criteria

• abdominal circumference + upper limbs along the body > 200cm
• addiction to alcohol or other psychoactive substances
• daily smoker
• sleep Apnea Syndrome paired
• psychotic psychiatric disorders
• history of bariatric surgery
• medical care in the nutrition unit
• inability to comprehend or complete questionnaires
• pregnant or breastfeeding woman
• persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients without food addictions	fMRI	Patients (20) will be selected from the Yale Food Addiction Scale (YFAS): a validated screening of FA questionnaire. Three clinical visits will be realized in less than two months
Patients without food addictions	Indirect calorimetry	Patients (20) will be selected from the Yale Food Addiction Scale (YFAS): a validated screening of FA questionnaire. Three clinical visits will be realized in less than two months
Patient with food addcitions	fMRI	Patients (20) will be selected from the Yale Food Addiction Scale (YFAS): a validated screening of FA questionnaire. Three clinical visits will be realized in less than two months
Patient with food addcitions	Bioimpedance	Patients (20) will be selected from the Yale Food Addiction Scale (YFAS): a validated screening of FA questionnaire. Three clinical visits will be realized in less than two months
Patient with food addcitions	Lipid profile, glucose, HBA1c, metabolomic analysis	Patients (20) will be selected from the Yale Food Addiction Scale (YFAS): a validated screening of FA questionnaire. Three clinical visits will be realized in less than two months
Patients without food addictions	YFAS questionnaire, Binge Eating Scale, Hospital Anxiety and Depression (HAD) scale, hedonic evaluation test (liking)	Patients (20) will be selected from the Yale Food Addiction Scale (YFAS): a validated screening of FA questionnaire. Three clinical visits will be realized in less than two months
Patient with food addcitions	Indirect calorimetry	Patients (20) will be selected from the Yale Food Addiction Scale (YFAS): a validated screening of FA questionnaire. Three clinical visits will be realized in less than two months
Patient with food addcitions	YFAS questionnaire, Binge Eating Scale, Hospital Anxiety and Depression (HAD) scale, hedonic evaluation test (liking)	Patients (20) will be selected from the Yale Food Addiction Scale (YFAS): a validated screening of FA questionnaire. Three clinical visits will be realized in less than two months
Patients without food addictions	Bioimpedance	Patients (20) will be selected from the Yale Food Addiction Scale (YFAS): a validated screening of FA questionnaire. Three clinical visits will be realized in less than two months
Patients without food addictions	Lipid profile, glucose, HBA1c, metabolomic analysis	Patients (20) will be selected from the Yale Food Addiction Scale (YFAS): a validated screening of FA questionnaire. Three clinical visits will be realized in less than two months

Primary Outcome Measures

Name	Time	Method
Significant change in brain activity of the prefrontal cortex (area involved in the inhibitory control of food intake) measured by modification of BOLD (Blood-Oxygen-Level-Dependent) signal in fMRI during a cognitive task based on food choice making	Month 2

Trial Locations

Locations (1)

CHU de Rennes; 🇫🇷 Rennes, France