Cognitive Processes Study in Obese Women With and Without Eating Disorders (P300)

August 26, 2016 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre Bénite, France, 69310
        • CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé Centre Hospitalier Lyon Sud - Pavillon médical 165, chemin du Grand Revoyet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: obese women with eating disorders
Obese women with eating disorders : women with BMI higher or equal 35 and disinhibition score to TFEQ strictly higher to 8
Biological: Blood sampling
Procedure: electroencephalography
Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)
OTHER: Obese women without eating desorders
Obese women without eating disorders : women with BMI higher or equal to 35 and disinhibition score to TFEQ lower or equal to 8
Biological: Blood sampling
Procedure: electroencephalography
Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)
OTHER: Lean women
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
Biological: Blood sampling
Procedure: electroencephalography
Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the beginning of the exploration visit (when patient is fasting) that will take place between 1 and 15 days after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auditory ERP ( latency P300, amplitude and latency of N2 wave recorded from frontal, central and parietal electrode)
Time Frame: fasting (up to 15 days)
The technique of auditory ERP will be an auditory discriminated task paradigm
fasting (up to 15 days)
assessment of dietary restraints and disinhibition
Time Frame: fasting (up to 15 days)
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).
fasting (up to 15 days)
glucose, insulin, leptin and ghrelin plasmatic rate
Time Frame: fasting (up to 15 days)
respectively reverse-phase high-performance liquid chromatography (RP-HPLC), ImmunoRadio Metric (IRMA) and ELISA assay
fasting (up to 15 days)
dopamine D2 receptor Taq 1 polymorphism
Time Frame: fasting (up to 15 days)
Real time PCR
fasting (up to 15 days)
Dietary intake and eating patterns
Time Frame: At day 1 and at day 15
Women will be interviewed by dietician, using a 24 h food questionnaire with additional questions regarding health and eating habits
At day 1 and at day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Emmanuel DISSE, Pratician, CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé - Centre Hospitalier Lyon Sud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

September 2, 2013

First Submitted That Met QC Criteria

September 18, 2013

First Posted (ESTIMATE)

September 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 26, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012.784

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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