Cognitive Processes Study in Obese Women With and Without Eating Disorders

NCT01948414 | Completed DMC

• 1 other identifier: 2012.784
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Obesity; Hyperalimentation; Event-Related Potential; P300

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  fasting (up to 15 days)

• assessment of dietary restraints and disinhibition

  fasting (up to 15 days)

• glucose, insulin, leptin and ghrelin plasmatic rate

  fasting (up to 15 days)

• dopamine D2 receptor Taq 1 polymorphism

  fasting (up to 15 days)

• Dietary intake and eating patterns

  At day 1 and at day 15

Study Arms (3)

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

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

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

Procedure: electroencephalography; Biological: Blood sampling; Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)

Interventions

electroencephalography PROCEDURE

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) BEHAVIORAL

Lean women; Obese women without eating desorders; obese women with eating disorders

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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, France

Location

Related Publications (1)

• 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

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Hyperphagia; Obesity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Emmanuel DISSE, Pratician

  CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé - Centre Hospitalier Lyon Sud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: September 23, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)