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OpenTrials
Completed

NCT Number: NCT03454711

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

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

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Key information

Conditions

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

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHU de Rennes

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fMRI

Device

Brain MRI

Indirect calorimetry

Device

Resting energy expenditure

Bioimpedance

Device

Measurement of body composition

Lipid profile, glucose, HBA1c, metabolomic analysis

Biological

Blood sample

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

Behavioral

Questionnaires to characterize eating habits and depression

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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Institut NuMeCan, INRAE 1341

Registry information

Acronym: AddictO

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 6, 2018
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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