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

NCT ID: NCT03454711

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-26

Study Completion Date

2021-09-08

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

fMRI

Intervention Type DEVICE

Brain MRI

Indirect calorimetry

Intervention Type DEVICE

Resting energy expenditure

Bioimpedance

Intervention Type DEVICE

Measurement of body composition

Lipid profile, glucose, HBA1c, metabolomic analysis

Intervention Type BIOLOGICAL

Blood sample

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

Intervention Type BEHAVIORAL

Questionnaires to characterize eating habits and depression

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

Group Type EXPERIMENTAL

fMRI

Intervention Type DEVICE

Brain MRI

Indirect calorimetry

Intervention Type DEVICE

Resting energy expenditure

Bioimpedance

Intervention Type DEVICE

Measurement of body composition

Lipid profile, glucose, HBA1c, metabolomic analysis

Intervention Type BIOLOGICAL

Blood sample

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

Intervention Type BEHAVIORAL

Questionnaires to characterize eating habits and depression

Interventions

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fMRI

Brain MRI

Intervention Type DEVICE

Indirect calorimetry

Resting energy expenditure

Intervention Type DEVICE

Bioimpedance

Measurement of body composition

Intervention Type DEVICE

Lipid profile, glucose, HBA1c, metabolomic analysis

Blood sample

Intervention Type BIOLOGICAL

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

Questionnaires to characterize eating habits and depression

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut NuMeCan, INRAE 1341

UNKNOWN

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Val-Laillet, MSc, PhD, HDR

Role: STUDY_DIRECTOR

Institut NuMeCan, INRA 1341, INSERM 1241, Université de Rennes 1

Locations

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CHU de Rennes

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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2017-A01269-44

Identifier Type: OTHER

Identifier Source: secondary_id

35RC17_8949_AddictO

Identifier Type: -

Identifier Source: org_study_id

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