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CompletedNCT01948414P300Updated Dec 19, 2025

Cognitive Processes Study in Obese Women With and Without Eating Disorders

An interventional study of electroencephalography and Blood sampling in Hyperalimentation and Obesity, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to female participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Non-randomized
Ages
20 Years to 55 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Hyperalimentation and Obesity

Keywords

  • Obesity
  • Hyperalimentation
  • Event-Related Potential
  • P300
03

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • 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

    Procedure: electroencephalography · Biological: Blood sampling · 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

    Procedure: electroencephalography · Biological: Blood sampling · 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

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

Interventions

  • Procedureelectroencephalography
  • BiologicalBlood sampling
  • BehavioralQuestionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)
05

What researchers measure

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.

    Time frame: At the beginning of the exploration visit (when patient is fasting) that will take place between 1 and 15 days after inclusion

Secondary outcomes

  1. Auditory ERP ( latency P300, amplitude and latency of N2 wave recorded from frontal, central and parietal electrode)

    The technique of auditory ERP will be an auditory discriminated task paradigm

    Time frame: fasting (up to 15 days)

  2. assessment of dietary restraints and disinhibition

    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).

    Time frame: fasting (up to 15 days)

  3. glucose, insulin, leptin and ghrelin plasmatic rate

    respectively reverse-phase high-performance liquid chromatography (RP-HPLC), ImmunoRadio Metric (IRMA) and ELISA assay

    Time frame: fasting (up to 15 days)

  4. dopamine D2 receptor Taq 1 polymorphism

    Real time PCR

    Time frame: fasting (up to 15 days)

  5. Dietary intake and eating patterns

    Women will be interviewed by dietician, using a 24 h food questionnaire with additional questions regarding health and eating habits

    Time frame: At day 1 and at day 15

06

Study locations

1 site
  • 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
07

References and documents

Publications

  • 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

Related links

08

Registry details

Key details

Study ID
NCT01948414
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Sep 23, 2013
Start date
Jul 2013
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Dec 19, 2025

Study contacts

Emmanuel DISSE, Pratician
principal investigator · CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé - Centre Hospitalier Lyon Sud

Oversight

Data monitoring committee
Yes
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