Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

A Study to Characterize Event Related Potential Markers of Attentional Bias Towards Words and Images of Food

11 agosto 2014 aggiornato da: GlaxoSmithKline

An Experimental Medicine Study to Characterize Event Related Potential Markers of Attentional Bias Towards Words and Images of Food in Healthy Volunteers

GSK is planning to undertake two anti-obesity drug studies in the area of obesity. In addition to assessment by questionnaires, it would be of significant value to incorporate an objective non-interventional measure of cognitive or motivational processing associated with evaluating and responding to food stimuli. Obesity is associated with increased attentional bias to palatable foods. The aims of this protocol are two-fold, first to characterize Event Related Potentials (ERPs) of two common aspects of food stimuli relevant to eating disorders -presence of food and its palatability, and secondly, to assess the modulation of these ERPs by appetite. Following a successful completion of this study, it is the intention to use the paradigm developed in future studies in the area of obesity.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

GlaxoSmithKline is currently developing a number of drugs for the treatment of overheating including 'binge eating' in obesity. Historically, the behavioural effectiveness of anti-obesity drugs in clinical drug trials have utilised subjective rating scales to assess a person's drive or motivation to eat. Findings from these studies have good construct validity, but suffer from the shortcomings of self-reporting, e.g. the subject bias, dishonesty, misinterpretation. It follows that in addition to self-reporting, it would strengthen the interpretation of any future studies on anti-obesity drugs, if there were to be an objective measure of brain activity in relation to cognitive/motivational processes associated with evaluation and responding to food related cues.

Measuring event related potentials (ERPs) during cognitive processes of food related cues, using the electroencephalography technique (EEG) offers a an alternative objective approach to examining the effectives of anti-obesity drugs.

This protocol proposes to develop and use two cognitive tasks examining response to food related cues (pictorial and words) with concurrent recording of ERPs, in order to characterize neurophysiological events associated with attentional bias towards food related stimuli.

The first task is an image processing task. This task uses food images similar to those in the International Affective Picture System (IAPS) used in ERP studies of perceptual processing of emotional stimuli [Olofsson, 2008; Schupp, 2006]. In this task a subject views different categories of images; palatable high-calorie food images, non-palatable low-calorie food images and non-edible plant images. The latter is the neutral category against which the ERPs of the two food categories will be compared. Affective pictures have been used to assess emotional valence by measuring differences in anterior ERP measurements between images from differing groups.

The protocol also proposes to measure late positive potential in order to assess higher level cognitive processing possibly with early memory formation. Again, the proposal is to assess AUCs, in this case in the 400-600 ms region and then look at difference curves between the late potential potentials to different valency stimuli. For the late positive potentials, anterior laterality will also be assessed. The second task is a cued-target task of visuospatial attention to motivationally salient words. The task is a version of the Posner paradigm. The appearance of a food or nonfood word inside a top or bottom frame (the cue) distracts the attention of the subject towards that spatial location. Following the word either one of the two frames changes appearance (the target).

In addition to these emotion and attention measures, the protocol proposes to assess the more standard N1, P1 and P3 [Luck, 2005]. After completing the ERP recordings the subject will be asked to rate each picture for salience and valence in order to provide a comparison between objective neurophysiological and subjective attention and emotional ratings.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

5

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
      • Cambridge, Regno Unito, CB2 2GG
        • GSK Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

  • Healthy as judged by the responsible physician or designee based on a medical evaluation including medical history.

    1. Right handed male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
    2. BMI within the range 27 - 35 kg/m2 (inclusive).
    3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:

    1. The subject has either a previous disease or current medical condition, which as judged by the Investigator, may affect the interpretation of efficacy data. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, psychiatric diseases or endocrine disease.
    2. The subject has a positive urine drug screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids, Methadone and Benzodiazepines.
    3. The subject has a history of alcohol or substance abuse or dependence in the 6 months prior to screening as determined by the investigator. Abuse of alcohol, defined for males, as an average weekly intake of greater than 28 units (or an average daily intake of greater than 4 units). One unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1 glass (125mL) of wine.
    4. A positive alcohol breath test.
    5. The subject has a history of stroke, seizures, epilepsy or abnormal EEG.
    6. The subject is a smoker.
    7. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
    8. Subjects who are currently taking any regular medication.
    9. Subject has a history of clinically significant eating disorders.
    10. Subject is a vegetarian.
    11. Subject is a member of GlaxoSmithKline Clinical Unit staff.
    12. Subject is female.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Visit B
At approximately 09:00 the subject will be given breakfast. After this, no food will be served until study procedures for the day are over. However, a 330 ml bottle of still water at room temperature will be given at ~11:00 and at ~13:00. During this period the subject will be required to remain in the unit.
Altro: High calorie lunch
Subject fed a standard high calorie lunch at 1pm
Altro: Breakfast
At approximately 09:00 the subject will be given breakfast. After this, no food will be served until study procedures for the day are over. However, a 330 ml bottle of still water at room temperature will be given at ~11:00 and at ~13:00. During this period the subject will be required to remain in the unit.
Altro: Visit A
At approximately 13:00 the subject will be given a standard high calorie lunch that the subject is required to finish
Altro: High calorie lunch
Subject fed a standard high calorie lunch at 1pm
Altro: Breakfast
At approximately 09:00 the subject will be given breakfast. After this, no food will be served until study procedures for the day are over. However, a 330 ml bottle of still water at room temperature will be given at ~11:00 and at ~13:00. During this period the subject will be required to remain in the unit.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Event Related Potential Amplitude, Latency and Area Under the Curve, Reaction
Lasso di tempo: 1 hour
1 hour

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Hip-to-waist ratio and BMI
Lasso di tempo: 6 hours
6 hours

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2009

Completamento primario (Effettivo)

1 dicembre 2009

Completamento dello studio (Effettivo)

1 ottobre 2010

Date di iscrizione allo studio

Primo inviato

14 aprile 2011

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2011

Primo Inserito (Stima)

6 giugno 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

13 agosto 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 agosto 2014

Ultimo verificato

1 agosto 2014

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 112336

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su High calorie lunch

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in United States

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi