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CompletedNCT03454711AddictOUpdated Aug 1, 2023

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

A Phase 2/3 interventional study of fMRI and Indirect calorimetry in Obesity, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to female participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by Rennes University Hospital · Phase 2/3, Interventional, and Other

Phase
Phase 2/3
Study type
Interventional
Enrollment
47
Allocation
Non-randomized
Ages
30 Years to 50 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Obesity

Keywords

  • Obesity
  • Food addictions
  • Functional magnetic resonance imaging (fMRI)
  • Metabolomics
03

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • 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: 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)

  • 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: 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

  • DevicefMRI

    Brain MRI

  • DeviceIndirect calorimetry

    Resting energy expenditure

  • DeviceBioimpedance

    Measurement of body composition

  • BiologicalLipid profile, glucose, HBA1c, metabolomic analysis

    Blood sample

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

    Questionnaires to characterize eating habits and depression

05

What researchers measure

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

    Time frame: Month 2

06

Study locations

1 site
  • CHU de Rennes
    Rennes, 35033, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03454711
Lead sponsor
Rennes University Hospital
Collaborators
Institut NuMeCan, INRAE 1341
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Apr 26, 2018
Primary completion
Sep 8, 2021
Completion
Sep 8, 2021
Last update
Aug 1, 2023

Study contacts

David Val-Laillet, MSc, PhD, HDR
study director · Institut NuMeCan, INRA 1341, INSERM 1241, Université de Rennes 1

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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