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

Obesity Clinical Trial

— AddictO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454711
• Other study ID #: 35RC17_8949_AddictO
• Secondary ID: 2017-A01269-44
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 26, 2018
• Est. completion date: September 8, 2021

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 8, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Addictive
• Food Addiction
• Obesity

Intervention

Device:
• fMRI
Brain MRI
• Indirect calorimetry
Resting energy expenditure
• Bioimpedance
Measurement of body composition

Biological:
• Lipid profile, glucose, HBA1c, metabolomic analysis
Blood sample

Behavioral:
• YFAS questionnaire, Binge Eating Scale, Hospital Anxiety and Depression (HAD) scale, hedonic evaluation test (liking)
Questionnaires to characterize eating habits and depression

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Institut NuMeCan, INRAE 1341

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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