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Not yet recruiting NCT07344831

Impact of Fatty Stimuli on Cerebral Activity in Anorexia Nervosa: a Multi-sensory Approach

No phase Interventional Anorexia Nervosa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI examination, Smell and taste capacity testings.
Who it may be relevant to
Registry conditions: Anorexia Nervosa. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Lipid restriction is significant in anorexia nervosa and limits therapeutic management. The multisensory perception of fat is altered, creating an aversion to lipids. The investigators aim to characterize the impact of sensory stimulation (smells or images) associated with specific tastes using neuropsychological assessments and functional MRI. Some volatile aromas can enhance the perception of the associated taste. The investigators hypothesize that such associations are altered in anorexia nervosa for fatty foods but may be preserved for sweet tastes, and that this alteration contributes to the maintenance of the disease. The interdependence of different sensory perceptions of lipids could play a major role in the therapeutic approach, aiding in the deconditioning of this aversion and the restoration of positive food sensory associations.

Interventions

  • Other MRI examination
    One hour MRI examination
  • Other Smell and taste capacity testings
    one hour sensory testings

Primary outcome measures

  • Brain activity measured by functional MRI [Time frame: Day 1]
Secondary outcome measures (6)
  • Brain activity measured by functional MRI [Time frame: Day 1]
  • Brain activity measured by functional MRI [Time frame: Day 1]
  • Brain activity measured by functional MRI [Time frame: Day 1]
  • BMI [Time frame: DAY 1.]
  • Olfactory and gustatory abilities [Time frame: Day 1]
  • 3DT1 morphological MRI [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Person affiliated or entitled to a social security scheme
  • Person having received informed information on the study and having co-signed, with the investigator, a consent to participate in the study
  • female person
  • Person affiliated or entitled to a social security scheme
  • Over 18 years'old
  • Knowing how to read and write French
  • Patient diagnosed with anorexia nervosa according to DSM-5 criteria for at least 5 years (HAS criteria). Failure of prior outpatient or/and hospitalization care over the last 12 months: stable or falling low BMI, unmodified food restriction, continued fear of weight gain, disturbances in the perception of body image
  • BMI < 18.5 kg/m² for volunteers in a state of constitutional thinness. The absence of eating disorder and the absence of restriction to DEBQ questionnaires. Fertility preserved.
  • For volunteers of normal weight: 18.5 kg/m² < BMI < 25 kg/m²

Exclusion criteria

  • Pregnant women, parturient, nursing mothers;
  • Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than research;
  • Minors
  • Refusal of the study by the participant
  • Person incapable of giving informed consent
  • Artificial nutrition
  • Associated organic damage favoring undernutrition: other chronic diseases (digestive, infectious, endocrine, pulmonary, cardiac, neurological), neoplasms, etc.
  • Abuse of psychoactive substances except tobacco
  • Characterized depressive episode, psychosis
  • Score less than 14 on the Edinburgh laterality questionnaire.
  • Contraindications to MRI or allergy to one of the components of the olfactory and taste tests
  • Smokers
  • Smell or taste alterations

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • CHU de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT07344831 · 24CH172 · ANSM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗