Back to resultsFunctional 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 (AddictO)
Primary Purpose
Obesity
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
fMRI
Indirect calorimetry
Bioimpedance
Lipid profile, glucose, HBA1c, metabolomic analysis
YFAS questionnaire, Binge Eating Scale, Hospital Anxiety and Depression (HAD) scale, hedonic evaluation test (liking)
Sponsored by
About this trial
This is an interventional other trial for Obesity focused on measuring Obesity, Food addictions, Functional magnetic resonance imaging (fMRI), Metabolomics
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.
Sites / Locations
- CHU de Rennes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patient with food addcitions
Patients without food addictions
Arm Description
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 (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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03454711
First Posted
February 20, 2018
Last Updated
July 27, 2023
Sponsor
Rennes University Hospital
Collaborators
Institut NuMeCan, INRAE 1341
1. Study Identification
Unique Protocol Identification Number
NCT03454711
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
September 8, 2021 (Actual)
Study Completion Date
September 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Institut NuMeCan, INRAE 1341
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Food addictions, Functional magnetic resonance imaging (fMRI), Metabolomics
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with food addcitions
Arm Type
Experimental
Arm Description
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
Arm Title
Patients without food addictions
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
fMRI
Intervention Description
Brain MRI
Intervention Type
Device
Intervention Name(s)
Indirect calorimetry
Intervention Description
Resting energy expenditure
Intervention Type
Device
Intervention Name(s)
Bioimpedance
Intervention Description
Measurement of body composition
Intervention Type
Biological
Intervention Name(s)
Lipid profile, glucose, HBA1c, metabolomic analysis
Intervention Description
Blood sample
Intervention Type
Behavioral
Intervention Name(s)
YFAS questionnaire, Binge Eating Scale, Hospital Anxiety and Depression (HAD) scale, hedonic evaluation test (liking)
Intervention Description
Questionnaires to characterize eating habits and depression
Primary Outcome Measure Information:
Title
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
Time Frame
Month 2
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Val-Laillet, MSc, PhD, HDR
Organizational Affiliation
Institut NuMeCan, INRA 1341, INSERM 1241, Université de Rennes 1
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this 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
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