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CompletedNCT03454711AddictOUpdated Aug 1, 2023

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

A Phase 2/3 interventional study of fMRI and Indirect calorimetry in Obesity, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to female participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by Rennes University Hospital · Phase 2/3, Interventional, and Other

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Phase
Phase 2/3
Study type
Interventional
Enrollment
47
Allocation
Non-randomized
Ages
30 Years to 50 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 475 studies in Obesity with a site in France — 111 open to participants now, 127 under way, 25 of them phase 3. Obesity · France.

Enrollment
238th of 354
47 · median 80
Started
2018
with 29 others
Phase 2/3
3 of 475
none open now
Registered
230th of 475
by date

Among the 475 studies in Obesity with a site in France, this one is the 238th largest by enrollment of the 354 interventional ones that give a count, is one of 30 that started in 2018, is one of 3 in phase 2/3, and was the 230th registered.

Obesity

11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.

Browse Obesity studies →

Open to participants now

111 of the 475 studies in Obesity with a site in France are open now. Recruiting first, the newest first:

106 more — sign in →

All 111 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.

This study: 30 Years to 50 Years · female · no healthy volunteers.

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02

Study summary

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

Read the detailed description

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.

03

Conditions studied

  • Obesity

Keywords

  • Obesity
  • Food addictions
  • Functional magnetic resonance imaging (fMRI)
  • Metabolomics
04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • female
  • right-handed
  • grade 1 and 2 obesity
  • aged between 20 and 50
  • no other addictions including smoking
  • no to fMRI
  • affiliated to French Social Security
  • having given a written

Exclusion criteria

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    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

    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)

  • Experimental
    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

    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)

Interventions

  • DevicefMRI

    Brain MRI

  • DeviceIndirect calorimetry

    Resting energy expenditure

  • DeviceBioimpedance

    Measurement of body composition

  • BiologicalLipid profile, glucose, HBA1c, metabolomic analysis

    Blood sample

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

    Questionnaires to characterize eating habits and depression

06

What researchers measure

Primary outcomes

  1. Significant change in brain activity of the prefrontal cortex (area involved in the inhibitory control of food intake) measured by modification of BOLD (Blood-Oxygen-Level-Dependent) signal in fMRI during a cognitive task based on food choice making

    Time frame: Month 2

07

Study locations

1 site
  • CHU de Rennes
    Rennes, 35033, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Sep 2021, 40 months.

Of 33 non-industry phase 2/3 interventional studies under Obesity, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 53. This study's 40 months is below that.

Counting every sponsor, half of 36 studies reached it within 47 months; a quarter within 30 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2018
First posted
Mar 6, 2018
StartActual
Apr 26, 2018
Primary completionActual
Sep 8, 2021
CompletionActual
Sep 8, 2021
Last update
Aug 1, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03454711
Collaborators
Institut NuMeCan, INRAE 1341
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Apr 26, 2018
Primary completion
Sep 8, 2021
Completion
Sep 8, 2021
Last update
Aug 1, 2023

Study contacts

David Val-Laillet, MSc, PhD, HDR
study director · Institut NuMeCan, INRA 1341, INSERM 1241, Université de Rennes 1

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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