NCT00842569

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

11 months

First QC Date

February 11, 2009

Last Update Submit

February 11, 2009

Conditions

Obesity

Keywords

obesitycognitive processrewardP300ERPEvent-related potential during oddball paradigmbrain electrophysiological patternsexternalizing factor

Outcome Measures

Primary Outcomes (1)

  • Evaluation of amplitudes and latencies of the P300 complex of Event Related Potential during an oddball paradigm, in normal-weighted and obese subjects

Study Arms (2)

Normal weighted

BMI\<25

Obese

BMI\>30

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

a healthy but normal-weighted or obese population. Depressive state or eating disorders were carefully evaluated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Nutrition Humaine Rhone Alpes

Lyon, F69008, France

Location

Related Publications (3)

  • 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.

    PMID: 10418702BACKGROUND

  • Patrick 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.

    PMID: 16629688BACKGROUND

  • Yoon 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.

    PMID: 16644137BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emmanuel DISSE, MD

    CRNH Rhone-Alpes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

FR(1)