Last updated: 11/03/2018 12:54:17
A study to characterize event related potential markers of attentional bias towards words and images of food
GSK study ID
112336
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: An experimental medicine study to characterize event related potential markers of attentional bias towards words and images of food in healthy volunteers
Trial description: GSK is planning to undertake two anti-obesity drug studies in the area of obesity. Inaddition to assessment by questionnaires, it would be of significant value to incorporatean objective non-interventional measure of cognitive or motivational processingassociated with evaluating and responding to food stimuli. Obesity is associated withincreased 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.
Primary purpose:
Basic Science
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Event Related Potential Amplitude, Latency and Area Under the Curve, Reaction
Timeframe: 1 hour
Secondary outcomes:
Hip-to-waist ratio and BMI
Timeframe: 6 hours
Interventions:
Other: High calorie lunch
Other: Breakfast
Enrollment:
5
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Obesity
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2009 to December 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Healthy as judged by the responsible physician or designee based on a medical evaluation
- including medical history.
- A subject will not be eligible for inclusion in this study if any of the following criteria
- apply:
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2009-09-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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