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Completed

NCT Number: NCT01948414

Cognitive Processes Study in Obese Women With and Without Eating Disorders

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.

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Key information

Conditions

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

Age range

20 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electroencephalography

Procedure

Blood sampling

Biological

Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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).

  3. 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

  4. dopamine D2 receptor Taq 1 polymorphism

    Time frame: fasting (up to 15 days)

    Real time PCR

  5. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Cognitive Processes Study in Obese Women With and Without Eating Disorders : Research of Electro-physiological Similarity With Addiction

Acronym: P300

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2013
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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