- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07344831
Impact of Fatty Stimuli on Cerebral Activity in Anorexia Nervosa: a Multi-sensory Approach (ANOVERSION)
January 8, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fabien SCHNEIDER, MD
- Phone Number: +33 (0)477127529
- Email: fabien.schneider@univ-st-etienne.fr
Study Contact Backup
- Name: Florence RANCON, CDP
- Phone Number: +33 (0)477829458
- Email: florenc.rancon@chu-st-etienne.fr
Study Locations
-
-
-
Saint-Etienne, France, 42055
- CHU de Saint-Etienne
-
Sub-Investigator:
- Natacha GERMAIN, MD PhD
-
Sub-Investigator:
- Bogdan GALUSCA, MD PhD
-
Contact:
- Fabien SCHNEIDER, MD
- Phone Number: +33 (0)477127529
- Email: fabien.schneider@chu-st-etienne.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Anorexia Nervosa patient group
30 patients with anorexia nervosa
|
One hour MRI examination
one hour sensory testings
|
|
Active Comparator: Normal Weight Control group
30 control subjects of normal weight
|
One hour MRI examination
one hour sensory testings
|
|
Active Comparator: Low Weight Control group
30 control subjects with a similar weight to AN patients (the constitutional thinness group)
|
One hour MRI examination
one hour sensory testings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain activity measured by functional MRI
Time Frame: Day 1
|
Estimation of the "fatty vs. neutral" contrast when all three senses are used, comparing AN patients to the normal-weight control group (NC group) in each voxel of the brain volume (whole-brain analysis) and in the orbitofrontal cortex (ROI analysis).
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain activity measured by functional MRI
Time Frame: Day 1
|
Estimation of the "fatty vs. neutral" contrast when all three senses are used, comparing AN patients to the control group with a similar BMI (CT group) in each voxel of the brain volume (whole-brain analysis) and in the orbitofrontal cortex (ROI analysis).
|
Day 1
|
|
Brain activity measured by functional MRI
Time Frame: Day 1
|
BOLD signal variations between the groups (AN, NC, and CT) for the "sweet vs. neutral" contrast.
|
Day 1
|
|
Brain activity measured by functional MRI
Time Frame: Day 1
|
BOLD signal variations for single vs. three senses simultaneously for each group and between groups for the "fatty vs. neutral" and "sweet vs. neutral" contrasts.
|
Day 1
|
|
BMI
Time Frame: DAY 1.
|
Body Mass Index
|
DAY 1.
|
|
Olfactory and gustatory abilities
Time Frame: Day 1
|
MediSens tests of olfactory and gustatory abilities
|
Day 1
|
|
3DT1 morphological MRI
Time Frame: Day 1
|
Brain morphometric measures and voxel-based morphometry.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Study Registration Dates
First Submitted
December 22, 2025
First Submitted That Met QC Criteria
January 8, 2026
First Posted (Actual)
January 15, 2026
Study Record Updates
Last Update Posted (Actual)
January 15, 2026
Last Update Submitted That Met QC Criteria
January 8, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24CH172
- ANSM (Other Identifier: 2025-A02921-48)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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