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Brain Electrophysiological Patterns in Obesity

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ClinicalTrials.gov Identifier: NCT00842569
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : February 12, 2009
Sponsor:
Information provided by:
Centre de Recherche en Nutrition Humaine Rhone-Alpe

Tracking Information
First Submitted Date February 11, 2009
First Posted Date February 12, 2009
Last Update Posted Date February 12, 2009
Study Start Date January 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2009)
Evaluation of amplitudes and latencies of the P300 complex of Event Related Potential during an oddball paradigm, in normal-weighted and obese subjects
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Brain Electrophysiological Patterns in Obesity
Official Title ERP Study of Brain Electrophysiological Patterns in Obesity
Brief 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. 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population a healthy but normal-weighted or obese population. Depressive state or eating disorders were carefully evaluated.
Condition Obesity
Intervention Not Provided
Study Groups/Cohorts
  • Normal weighted
    BMI<25
  • Obese
    BMI>30
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 11, 2009)
69
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00842569
Other Study ID Numbers CRNHRA-09-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Emmanuel DISSE, Centre de Recherche en Nutrition Humaine Rhone-Alpe
Study Sponsor Centre de Recherche en Nutrition Humaine Rhone-Alpe
Collaborators Not Provided
Investigators
Principal Investigator: Emmanuel DISSE, MD CRNH Rhone-Alpes
PRS Account Centre de Recherche en Nutrition Humaine Rhone-Alpe
Verification Date February 2009