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Cognitive Processes Study in Obese Women With and Without Eating Disorders

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01948414
Acronym
P300
Enrollment
108
Registered
2013-09-23
Start date
2013-07-31
Completion date
2015-06-30
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperalimentation and Obesity

Keywords

Obesity, Hyperalimentation, Event-Related Potential, P300

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.

Interventions

PROCEDUREelectroencephalography
BIOLOGICALBlood sampling
BEHAVIORALQuestionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 55 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
P300 amplitudeAt the beginning of the exploration visit (when patient is fasting) that will take place between 1 and 15 days after inclusionThe 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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026