ObesityPhase 2/3AddictONCT03454711
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 study testing fMRI, Indirect calorimetry and Bioimpedance in people with Obesity, run by Rennes University Hospital at 1 site in France.
Trial summary
Identification of the cerebral fMRI phenotype of obese patients with FA in cognitive task context based on food choice making Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- fMRI, Indirect calorimetry and Bioimpedance
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2018to 8 Sep 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity
- Being tested
- 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)
- Keywords
- Obesity, Food addictions, Functional magnetic resonance imaging (fMRI), Metabolomics
- Medical subject headings
- Obesity, Food Addiction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIDevice
Brain MRI
Indirect calorimetryDevice
Resting energy expenditure
BioimpedanceDevice
Measurement of body composition
Lipid profile, glucose, HBA1c, metabolomic analysisBiological
Blood sample
YFAS questionnaire, Binge Eating Scale, Hospital Anxiety and Depression (HAD) scale, hedonic evaluation test (liking)Behavioural
Questionnaires to characterize eating habits and depression
| Study group | Role | What they receive |
|---|---|---|
| Patient with food addcitions | Experimental | 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 Receives: 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 without food addictions | Experimental | 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start26 Apr 2018
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institut NuMeCan, INRAE 1341
- Responsible party
- Sponsor
- Investigators
- David Val-Laillet, MSc, PhD, HDR, Study director, Institut NuMeCan, INRA 1341, INSERM 1241, Université de Rennes 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454711
- Sponsor's protocol ID
- 35RC17_8949_AddictO
- Other IDs
- 2017-A01269-44
- Acronym
- AddictO
- Status last verified
- May 2023
- First submitted
- 20 Feb 2018
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03454711
- Acronym / sponsor ID
- AddictO / 35RC17_8949_AddictO
- Conditions
- Obesity
- Keywords
- Obesity, Food addictions, Functional magnetic resonance imaging (fMRI), Metabolomics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Institut NuMeCan, INRAE 1341
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Identification of the cerebral fMRI phenotype of obese patients with FA in cognitive task context based on food choice making
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- female
- right-handed
- grade 1 and 2 obesity
- aged between 20 and 50
- no other addictions including smoking
Key exclusion criteria (10 listed)
- abdominal circumference + upper limbs along the body > 200cm
- addiction to alcohol or other psychoactive substances
- daily smoker
- sleep Apnea Syndrome paired
- psychotic psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIBrain MRI | Device | Patient with food addcitions, Patients without food addictions |
| Indirect calorimetryResting energy expenditure | Device | Patient with food addcitions, Patients without food addictions |
| BioimpedanceMeasurement of body composition | Device | Patient with food addcitions, Patients without food addictions |
| Lipid profile, glucose, HBA1c, metabolomic analysisBlood sample | Biological | Patient with food addcitions, Patients without food addictions |
| YFAS questionnaire, Binge Eating Scale, Hospital Anxiety and Depression (HAD) scale, hedonic evaluation test (liking)Questionnaires to characterize eating habits and depression | Behavioural | Patient with food addcitions, Patients without food addictions |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Val-Laillet, MSc, PhD, HDR study director
Institut NuMeCan, INRA 1341, INSERM 1241, Université de Rennes 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing fMRI, Indirect calorimetry and Bioimpedance in people with Obesity, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.