ObesityPhase 1NCT01366508
A Study to Characterize Event Related Potential Markers of Attentional Bias Towards Words and Images of Food
A Phase 1 study testing High calorie lunch and Breakfast in people with Obesity, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- High calorie lunch and Breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Obesity
- Being tested
- High calorie lunch, Breakfast
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High calorie lunchOther
Subject fed a standard high calorie lunch at 1pm
BreakfastOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: High calorie lunch; Other: Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Related Potential Amplitude, Latency and Area Under the Curve, Reaction
Measured: 1 hour
Secondary outcomes (1)
Hip-to-waist ratio and BMI
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionOct 2010
Why it stopped: Results of the study would unfortunately no longer be of any scientific interest to the sponsor and would not be used to inform future studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366508
- Sponsor's protocol ID
- 112336
- Status last verified
- Aug 2014
- First submitted
- 14 Apr 2011
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Experimental Medicine Study to Characterize Event Related Potential Markers of Attentional Bias Towards Words and Images of Food in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01366508
- Acronym / sponsor ID
- 112336
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results of the study would unfortunately no longer be of any scientific interest to the sponsor and would not be used to inform future studies.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visit B | Other | Other: High calorie lunch, Other: BreakfastAt 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 | Other | Other: High calorie lunch, Other: BreakfastAt approximately 13:00 the subject will be given a standard high calorie lunch that the subject is required to finish |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy as judged by the responsible physician or designee based on a medical evaluation including medical history.
Key exclusion criteria (13 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High calorie lunchSubject fed a standard high calorie lunch at 1pm | Other | Visit A, Visit B |
| BreakfastAt 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 | Visit A, Visit B |
Primary outcome
Event Related Potential Amplitude, Latency and Area Under the Curve, Reaction
Time frame: 1 hour
1 secondary outcome
Hip-to-waist ratio and BMI
Time frame: 6 hours
Results and safety
The study was stopped early (reason given: Results of the study would unfortunately no longer be of any scientific interest to the sponsor and would not be used to inform future studies.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High calorie lunch and Breakfast in people with Obesity, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Results of the study would unfortunately no longer be of any scientific interest to the sponsor and would not be used to inform future studies.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event Related Potential Amplitude, Latency and Area Under the Curve, Reaction (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.