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

NCT01366508 | Terminated Phase 1

• 1 other identifier: 112336
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Event Related Potential Amplitude, Latency and Area Under the Curve, Reaction

  1 hour

Secondary Outcomes (1)

• Hip-to-waist ratio and BMI

  6 hours

Study Arms (2)

Visit B

OTHER

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.

Other: High calorie lunch; Other: Breakfast

Visit A

OTHER

At approximately 13:00 the subject will be given a standard high calorie lunch that the subject is required to finish

Other: High calorie lunch; Other: Breakfast

Interventions

High calorie lunch OTHER

Subject fed a standard high calorie lunch at 1pm

Visit A; Visit B

Breakfast OTHER

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.

Visit A; Visit B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy as judged by the responsible physician or designee based on a medical evaluation including medical history.
• Right handed male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
• BMI within the range 27 - 35 kg/m2 (inclusive).
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

You may not qualify if:

• 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.
• 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.
• 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.
• A positive alcohol breath test.
• The subject has a history of stroke, seizures, epilepsy or abnormal EEG.
• The subject is a smoker.
• 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).
• Subjects who are currently taking any regular medication.
• Subject has a history of clinically significant eating disorders.
• Subject is a vegetarian.
• Subject is a member of GlaxoSmithKline Clinical Unit staff.
• Subject is female.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cambridge, CB2 2GG, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

Breakfast

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Meals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: June 6, 2011
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: October 1, 2010
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

GB (1)