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 (AddictO)

July 27, 2023 updated by: Rennes University Hospital
Identification of the cerebral fMRI phenotype of obese patients with FA in cognitive task context based on food choice making

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • CHU de Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with food addcitions

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: Bioimpedance
Measurement of body composition
Device: fMRI
Brain MRI
Device: Indirect calorimetry
Resting energy expenditure
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
Experimental: Patients without food addictions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Month 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Institut NuMeCan, INRAE 1341

Investigators

  • Study Director: David Val-Laillet, MSc, PhD, HDR, Institut NuMeCan, INRA 1341, INSERM 1241, Université de Rennes 1

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2018

Primary Completion (Actual)

September 8, 2021

Study Completion (Actual)

September 8, 2021

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

March 5, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC17_8949_AddictO
  • 2017-A01269-44 (Other Identifier: N°ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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