| Registry | NCT03454711, acronym AddictO |
|---|---|
| Status | Completed |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; non randomized, parallel, masking: none, other |
| Enrollment | 47 (Actual) |
| Sponsor | Rennes University Hospital (Other); collaborators: Institut NuMeCan, INRAE 1341 |
| Conditions | Obesity |
| Interventions | 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) (Device, biological, behavioral) |
| Dates | start 2018-04-26, primary completion 2021-09-08, completion 2021-09-08, first posted 2018-03-06, last updated 2023-08-01 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Obesity All trials of fMRI All trials of Indirect calorimetry
Identification of the cerebral fMRI phenotype of obese patients with FA in cognitive task context based on food choice making
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Patient with food addcitions | Experimental | 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) | 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 without food addictions | Experimental | 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) | 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 |
Sex: Female, ages: 30 Years to 50 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| CHU de Rennes | Rennes | France |