ObesityNCT00842569
Brain Electrophysiological Patterns in Obesity
An observational study of Obesity, run by Centre de Recherche en Nutrition Humaine Rhone-Alpe at 1 site in France.
Trial summary
There is growing evidence of behavioural and neurobiological overlaps between obesity and drug abuse. Reduction of the amplitude of P300, a component of event-related potentials (ERP) elicited by an oddball paradigm, is an electrophysiological characteristic and a marker of vulnerability in substance abuse. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Dec 2008
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: a healthy but normal-weighted or obese population. Depressive state or eating disorders were carefully evaluated.
Who may be able to join
- The inclusion criteria for the study are men and women aged 20-60 years, BMI 18.5-24.9 kg/m2 for control subjects and BMI>30 kg/m2 for obese subjects, stable body weight over the previous 3 months, report of sedentary or moderate physical activity
Who cannot join
- The exclusion criteria are pregnancy, post-menopausal women, any physiological or psychological illness that could influence the results, subjects likely to take medical drugs interfering with the electrophysiological parameters of the study, diabetes, hearing disorder, intense physical activity and report or evidence of excessive alcohol consumption, depressive state or eating disorders according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ERP Study of Brain Electrophysiological Patterns in Obesity
There is growing evidence of behavioural and neurobiological overlaps between obesity and drug abuse. Reduction of the amplitude of P300, a component of event-related potentials (ERP) elicited by an oddball paradigm, is an electrophysiological characteristic and a marker of vulnerability in substance abuse. We want to determine whether obesity is associated with such electrophysiological features during an auditory oddball paradigm. We postulate that obesity could be associated with electrophysiological abnormalities that could be viewed as a possible vulnerability marker for food addiction.
- Conditions
- Obesity
- Keywords
- obesity, cognitive process, reward, P300, ERP, Event-related potential during oddball paradigm, brain electrophysiological patterns, externalizing factor
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal weighted | BMI<25 | |
| Obese | BMI>30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of amplitudes and latencies of the P300 complex of Event Related Potential during an oddball paradigm, in normal-weighted and obese subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche en Nutrition Humaine Rhone-Alpe
- Sponsor type
- University, hospital or other
- Investigators
- Emmanuel DISSE, MD, Principal investigator, CRNH Rhone-Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842569
- Sponsor's protocol ID
- CRNHRA-09-001
- Status last verified
- Feb 2009
- First submitted
- 11 Feb 2009
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Bauer LO, Hesselbrock VM. P300 decrements in teenagers with conduct problems: implications for substance abuse risk and brain development. Biol Psychiatry. 1999 Jul 15;46(2):263-72. doi: 10.1016/s0006-3223(98)00335-7.
PubMed 10418702Patrick CJ, Bernat EM, Malone SM, Iacono WG, Krueger RF, McGue M. P300 amplitude as an indicator of externalizing in adolescent males. Psychophysiology. 2006 Jan;43(1):84-92. doi: 10.1111/j.1469-8986.2006.00376.x.
PubMed 16629688Yoon HH, Iacono WG, Malone SM, McGue M. Using the brain P300 response to identify novel phenotypes reflecting genetic vulnerability for adolescent substance misuse. Addict Behav. 2006 Jun;31(6):1067-87. doi: 10.1016/j.addbeh.2006.03.036. Epub 2006 Apr 27.
PubMed 16644137
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERP Study of Brain Electrophysiological Patterns in Obesity
- ClinicalTrials.gov ID
- NCT00842569
- Acronym / sponsor ID
- CRNHRA-09-001
- Conditions
- Obesity
- Keywords
- obesity, cognitive process, reward, P300, ERP, Event-related potential during oddball paradigm, brain electrophysiological patterns, externalizing factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Centre de Recherche en Nutrition Humaine Rhone-AlpeUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- First posted
- 12 Feb 2009 (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.
There is growing evidence of behavioural and neurobiological overlaps between obesity and drug abuse. Reduction of the amplitude of P300, a component of event-related potentials (ERP) elicited by an oddball paradigm, is an electrophysiological characteristic and a marker of vulnerability in substance abuse. We want to determine whether obesity is associated with such electrophysiological features during an auditory oddball paradigm. We postulate that obesity could be associated with electrophysiological abnormalities that could be viewed as a possible vulnerability marker for food addiction.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weighted | – | –BMI<25 |
| Obese | – | –BMI>30 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- a healthy but normal-weighted or obese population. Depressive state or eating disorders were carefully evaluated.
Key inclusion criteria (1 listed)
- The inclusion criteria for the study are men and women aged 20-60 years, BMI 18.5-24.9 kg/m2 for control subjects and BMI>30 kg/m2 for obese subjects, stable body weight over the previous 3 months, report of sedentary or moderate physical activity
Key exclusion criteria (1 listed)
- The exclusion criteria are pregnancy, post-menopausal women, any physiological or psychological illness that could influence the results, subjects likely to take medical drugs interfering with the electrophysiological parameters of the study, diabetes, hearing disorder, intense physical activity and report or evidence of excessive alcohol consumption, depressive state or eating disorders according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of amplitudes and latencies of the P300 complex of Event Related Potential during an oddball paradigm, in normal-weighted and obese subjects
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 12 Feb 2009.
- Background: PubMed 10418702Bauer LO, Hesselbrock VM. P300 decrements in teenagers with conduct problems: implications for substance abuse risk and brain development. Biol Psychiatry. 1999 Jul 15;46(2):263-72. doi: 10.1016/s0006-3223(98)00335-7.
- Background: PubMed 16629688Patrick CJ, Bernat EM, Malone SM, Iacono WG, Krueger RF, McGue M. P300 amplitude as an indicator of externalizing in adolescent males. Psychophysiology. 2006 Jan;43(1):84-92. doi: 10.1111/j.1469-8986.2006.00376.x.
- Background: PubMed 16644137Yoon HH, Iacono WG, Malone SM, McGue M. Using the brain P300 response to identify novel phenotypes reflecting genetic vulnerability for adolescent substance misuse. Addict Behav. 2006 Jun;31(6):1067-87. doi: 10.1016/j.addbeh.2006.03.036. Epub 2006 Apr 27.
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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, MD principal investigator
CRNH Rhone-Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Centre de Recherche en Nutrition Humaine Rhone-Alpe 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 1 inclusion and 1 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 12 Feb 2009. 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?
Evaluation of amplitudes and latencies of the P300 complex of Event Related Potential during an oddball paradigm, in normal-weighted and obese subjects. 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 NCT00842569, which also lists 3 linked publications.
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 12 Feb 2009; AzTrials last refreshed its copy on 1 Nov 2026.