An investigation into the effects of glucose and caffeine on multitasking, mood and fMRI regional activation in healthy adults.

GlaxoSmithKline Nutritional Healthcare0 sites40 target enrollmentFebruary 17, 2012

Overview

No summary available.

Registry

who.int

Start Date

February 17, 2012

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

GlaxoSmithKline Nutritional Healthcare

•People who meet the following inclusion criteria will be included in the trial:
•1\. Male or female.
•2\. Aged 18\-55 years.
•3\. Willing and able to provide written informed consent.
•4\. Understands and is willing and able to comply with all study procedures.
•5\. Are in good general health with no history of psychiatric disease.
•6\. Regular caffeine consumers (between 1\-4 cups of coffee per day or equivalent i.e. soft drinks, energy drinks)
•7\. Must have corrected to normal vision
•8\. Participants who take part in the fMRI subcomponent must be right handed. This is for ease of analysis of the neuroimaging data. There are hemispheric differences in terms of structure between right and left handed individuals that prove to be problematic when analysing the output. Given that this investigation will employ a method where participants need to press buttons as a response (in turn involving the motor cortex), it is wise to use an all right handed population.

•Participants who display any of the following will be excluded from the trial:
•1\.Females who are pregnant, breast\-feeding and/or not using a medically approved form of contraception.
•2\. Individuals currently taking medication (other than the contraceptive pill – see section 4\.5\.2 for details).
•3\.Any significant concurrent illness including any bleeding disorders, heart conditions, diabetes, glaucoma, high blood pressure or osteoporosis.
•4\.Individuals who suffer from Diabetes Mellitus.
•5\.Any known or suspected food allergies (this would cover all ingredients in the investigational product).
•6\.Susceptible to any unwanted side\-effects of caffeine, such as reduction in sleep quality.
•7\.Smokers and users of recreational drugs (except alcohol and other food grade actives)
•8\.Have participated in any other study involving an investigational product in the last 4 weeks.
•9\.Have undergone an MRI scan within the previous 7 days.