Hyperalimentation and ObesityP300NCT01948414
Cognitive Processes Study in Obese Women With and Without Eating Disorders
A study testing electroencephalography, Blood sampling and Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD) in people with Hyperalimentation and Obesity, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The P300 is one of the cognitive wave of the Event-Related Potential (ERP) that is used to investigate the cognitive process. The P300 component are accepted as electro-physiological markers of neuropsychiatric disorders like alcoholism or drug addiction. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperalimentation and Obesity
- What is being tested?
- electroencephalography, Blood sampling and Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Jun 2015
- Phase
- Interventional
- 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 20 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women
- Aged from 20 to 55 years
- Fasting glycemia under 7mmol/L
- Lean women : women with BMI from 18.5 to 24.5 and disinhibition score to Three-Factor Eating Questionnaire (TFEQ)lower or equal to 8
- Obese women without eating disorders : women with BMI higher or equal to 35 and disinhibition score to TFEQ lower or equal to 8
- Obese women with eating disorders : women with BMI higher or equal 35 and disinhibition score to TFEQ strictly higher to 8
Who cannot join
- Subject not in compliance with the recommendations of French National Law in force
- Medical history of diabetes and surgery history of obesity
- Drug use that could affect the ERP recording
- Hospital Anxiety and Depression scale : evaluation subscale (anxiety and/or depression) strictly higher to 11
Trial locations and contacts
1 site in 1 country.
France1 site
CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé Centre Hospitalier Lyon Sud - Pavillon médical 165, chemin du Grand Revoyet
Pierre-Bénite, 69310
About this study
Official title: Cognitive Processes Study in Obese Women With and Without Eating Disorders : Research of Electro-physiological Similarity With Addiction
The P300 is one of the cognitive wave of the Event-Related Potential (ERP) that is used to investigate the cognitive process. The P300 component are accepted as electro-physiological markers of neuropsychiatric disorders like alcoholism or drug addiction.
Recent scientific data suggest that eating disorders, leading to weight gain and obesity, will be similar of those of drug addiction: it is the incentive sensitization theory that implicates the dopaminergic reward system.
The aim of this cross-sectional study is to investigate the alteration of P300 auditory ERP in obese women with eating disorders in comparison with obese and lean women without eating disorders.
- Conditions
- Hyperalimentation and Obesity
- Being tested
- electroencephalography, Blood sampling, Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)
- Keywords
- Obesity, Hyperalimentation, Event-Related Potential, P300
- Medical subject headings
- Hyperphagia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalographyProcedure or surgery
Blood samplingBiological
Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| obese women with eating disorders | Other | Obese women with eating disorders : women with BMI higher or equal 35 and disinhibition score to TFEQ strictly higher to 8 Receives: Procedure: electroencephalography; Biological: Blood sampling; Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD) |
| Obese women without eating desorders | Other | Obese women without eating disorders : women with BMI higher or equal to 35 and disinhibition score to TFEQ lower or equal to 8 Receives: Procedure: electroencephalography; Biological: Blood sampling; Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD) |
| Lean women | Other | Lean women : women with BMI from 18.5 to 24.5 and disinhibition score to Three-Factor Eating Questionnaire (TFEQ)lower or equal to 8 Receives: Procedure: electroencephalography; Biological: Blood sampling; Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
P300 amplitude
The auditory event-related potentials measure will be elicited with an auditory oddball paradigm. The activity will be recorded thanks to electroencephalography from frontal, central and parietal electrodes, using an electrode cap.
Measured: At the beginning of the exploration visit (when patient is fasting) that will take place between 1 and 15 days after inclusion
Secondary outcomes (5)
Auditory ERP ( latency P300, amplitude and latency of N2 wave recorded from frontal, central and parietal electrode)
The technique of auditory ERP will be an auditory discriminated task paradigm
Measured: fasting (up to 15 days)
assessment of dietary restraints and disinhibition
Participants will complete self-report questionnaires including Three-Factor Eating Questionnaire and Eating Disorders Inventory. The lean subjects should not have TFEQ disinhibition score more than 8. The obese subjects will be separated on two groups depending on TFEQ dishinibition score (strictly greater than 8, the obese with eating disorder, less than or equal 8, obese without eating disorder).
Measured: fasting (up to 15 days)
glucose, insulin, leptin and ghrelin plasmatic rate
respectively reverse-phase high-performance liquid chromatography (RP-HPLC), ImmunoRadio Metric (IRMA) and ELISA assay
Measured: fasting (up to 15 days)
dopamine D2 receptor Taq 1 polymorphism
Real time PCR
Measured: fasting (up to 15 days)
Dietary intake and eating patterns
Women will be interviewed by dietician, using a 24 h food questionnaire with additional questions regarding health and eating habits
Measured: At day 1 and at day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperalimentation and ObesityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel DISSE, Pratician, Principal investigator, CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé - Centre Hospitalier Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948414
- Sponsor's protocol ID
- 2012.784
- Acronym
- P300
- Status last verified
- Dec 2025
- First submitted
- 2 Sep 2013
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Iceta S., Benoit J., Lambert-Porcheron S., Peyrat J., Cristini P., Poulet E., Laville M., Disse E. Obésité, addiction et prise alimentaire : étude des potentiels évoqués cognitifs. Nutrition Clinique et Métabolisme. 2018;32:231-338 (Section " 232 Congrès ", résumé CO09). doi:10.1016/j.nupar.2018.09.007 / 2018.09.008
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Processes Study in Obese Women With and Without Eating Disorders : Research of Electro-physiological Similarity With Addiction
- ClinicalTrials.gov ID
- NCT01948414
- Acronym / sponsor ID
- P300 / 2012.784
- Conditions
- Hyperalimentation and Obesity
- Keywords
- Obesity, Hyperalimentation, Event-Related Potential, P300
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Sep 2013 (estimated)
- 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.
The P300 is one of the cognitive wave of the Event-Related Potential (ERP) that is used to investigate the cognitive process. The P300 component are accepted as electro-physiological markers of neuropsychiatric disorders like alcoholism or drug addiction.
Recent scientific data suggest that eating disorders, leading to weight gain and obesity, will be similar of those of drug addiction: it is the incentive sensitization theory that implicates the dopaminergic reward system.
The aim of this cross-sectional study is to investigate the alteration of P300 auditory ERP in obese women with eating disorders in comparison with obese and lean women without eating disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| obese women with eating disorders | Other | Procedure: electroencephalography, Biological: Blood sampling, Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)Obese women with eating disorders : women with BMI higher or equal 35 and disinhibition score to TFEQ strictly higher to 8 |
| Obese women without eating desorders | Other | Procedure: electroencephalography, Biological: Blood sampling, Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)Obese women without eating disorders : women with BMI higher or equal to 35 and disinhibition score to TFEQ lower or equal to 8 |
| Lean women | Other | Procedure: electroencephalography, Biological: Blood sampling, Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)Lean women : women with BMI from 18.5 to 24.5 and disinhibition score to Three-Factor Eating Questionnaire (TFEQ)lower or equal to 8 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- women
- Aged from 20 to 55 years
- Fasting glycemia under 7mmol/L
- Lean women : women with BMI from 18.5 to 24.5 and disinhibition score to Three-Factor Eating Questionnaire (TFEQ)lower or equal to 8
- Obese women without eating disorders : women with BMI higher or equal to 35 and disinhibition score to TFEQ lower or equal to 8
Key exclusion criteria (4 listed)
- Subject not in compliance with the recommendations of French National Law in force
- Medical history of diabetes and surgery history of obesity
- Drug use that could affect the ERP recording
- Hospital Anxiety and Depression scale : evaluation subscale (anxiety and/or depression) strictly higher to 11
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 |
|---|---|---|
| electroencephalography | Procedure or surgery | Lean women, Obese women without eating desorders, obese women with eating disorders |
| Blood sampling | Biological | Lean women, Obese women without eating desorders, obese women with eating disorders |
| Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD) | Behavioural | Lean women, Obese women without eating desorders, obese women with eating disorders |
Primary outcome
P300 amplitude
Time frame: At the beginning of the exploration visit (when patient is fasting) that will take place between 1 and 15 days after inclusion
The auditory event-related potentials measure will be elicited with an auditory oddball paradigm. The activity will be recorded thanks to electroencephalography from frontal, central and parietal electrodes, using an electrode cap.
5 secondary outcomes
Auditory ERP ( latency P300, amplitude and latency of N2 wave recorded from frontal, central and parietal electrode)
Time frame: fasting (up to 15 days)
assessment of dietary restraints and disinhibition
Time frame: fasting (up to 15 days)
glucose, insulin, leptin and ghrelin plasmatic rate
Time frame: fasting (up to 15 days)
dopamine D2 receptor Taq 1 polymorphism
Time frame: fasting (up to 15 days)
Dietary intake and eating patterns
Time frame: At day 1 and at day 15
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 19 Dec 2025.
- Results publicationIceta S., Benoit J., Lambert-Porcheron S., Peyrat J., Cristini P., Poulet E., Laville M., Disse E. Obésité, addiction et prise alimentaire : étude des potentiels évoqués cognitifs. Nutrition Clinique et Métabolisme. 2018;32:231-338 (Section " 232 Congrès ", résumé CO09). doi:10.1016/j.nupar.2018.09.007 / 2018.09.008
- Related InfoLink provided by the sponsor.
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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.
Emmanuel DISSE, Pratician principal investigator
CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé - Centre Hospitalier Lyon Sud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroencephalography, Blood sampling and Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD) in people with Hyperalimentation and Obesity, run by Hospices Civils de Lyon 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 6 inclusion and 4 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 19 Dec 2025. 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.
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?
P300 amplitude (time frame: At the beginning of the exploration visit (when patient is fasting) that will take place between 1 and 15 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01948414, which also lists 1 linked publication.
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 19 Dec 2025.