Clinical trial
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
Name
35RC17_8949_AddictO
Description
Identification of the cerebral fMRI phenotype of obese patients with FA in cognitive task context based on food choice making
Trial arms
Trial start
2018-04-26
Estimated PCD
2021-09-08
Trial end
2021-09-08
Status
Completed
Phase
Early phase I
Treatment
fMRI
Brain MRI
Arms:
Patient with food addcitions, Patients without food addictions
Indirect calorimetry
Resting energy expenditure
Arms:
Patient with food addcitions, Patients without food addictions
Bioimpedance
Measurement of body composition
Arms:
Patient with food addcitions, Patients without food addictions
Lipid profile, glucose, HBA1c, metabolomic analysis
Blood sample
Arms:
Patient with food addcitions, Patients without food addictions
YFAS questionnaire, Binge Eating Scale, Hospital Anxiety and Depression (HAD) scale, hedonic evaluation test (liking)
Questionnaires to characterize eating habits and depression
Arms:
Patient with food addcitions, Patients without food addictions
Size
47
Primary endpoint
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
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 47, 'type': 'ACTUAL'}}
Updated at
2023-08-01
1 organization
1 product
1 indication
Organization
Rennes University HospitalIndication
Obesity