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

September 15, 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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • CHU de Saint-Etienne
        • Sub-Investigator:
          • Natacha GERMAIN, MD PhD
        • Sub-Investigator:
          • Bogdan GALUSCA, MD PhD
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Anorexia Nervosa patient group
30 patients with anorexia nervosa
Other: MRI examination
One hour MRI examination
Other: Smell and taste capacity testings
one hour sensory testings
Active Comparator: Normal Weight Control group
30 control subjects of normal weight
Other: MRI examination
One hour MRI examination
Other: Smell and taste capacity testings
one hour sensory testings
Active Comparator: Low Weight Control group
30 control subjects with a similar weight to AN patients (the constitutional thinness group)
Other: MRI examination
One hour MRI examination
Other: Smell and taste capacity testings
one hour sensory testings

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24CH172
  • ANSM (Other Identifier: 2024-A02435-42)

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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