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

NCT03454711 | Completed Phase 2

• 2 other identifiers: 35RC17_8949_AddictO2017-A01269-44
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Obesity; Food addictions; Functional magnetic resonance imaging (fMRI); Metabolomics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patient with food addcitions

EXPERIMENTAL

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

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)

Patients without food addictions

EXPERIMENTAL

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

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)

Interventions

fMRI DEVICE

Brain MRI

Patient with food addcitions; Patients without food addictions

Indirect calorimetry DEVICE

Resting energy expenditure

Patient with food addcitions; Patients without food addictions

Bioimpedance DEVICE

Measurement of body composition

Patient with food addcitions; Patients without food addictions

Lipid profile, glucose, HBA1c, metabolomic analysis BIOLOGICAL

Blood sample

Patient with food addcitions; Patients without food addictions

YFAS questionnaire, Binge Eating Scale, Hospital Anxiety and Depression (HAD) scale, hedonic evaluation test (liking) BEHAVIORAL

Questionnaires to characterize eating habits and depression

Patient with food addcitions; Patients without food addictions

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead
• Institut NuMeCan, INRAE 1341: collaborator

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Obesity; Food Addiction

Interventions

Magnetic Resonance Imaging; Calorimetry, Indirect; Glucose; Weights and Measures

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Calorimetry; Chemistry Techniques, Analytical; Investigative Techniques; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• David Val-Laillet, MSc, PhD, HDR

  Institut NuMeCan, INRA 1341, INSERM 1241, Université de Rennes 1

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 6, 2018
• Study Start: April 26, 2018
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2021
• Last Updated: August 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)