An investigation into the effects of glucose and caffeine on multitasking, mood and fMRI

• Conditions: Cognitive function in healthy adults; neural activation in healthy adults; Alternative and Complementary Medicine - Other alternative and complementary medicine; Mental Health - Studies of normal psychology, cognitive function and behaviour; Neurological - Studies of the normal brain and nervous system

• Registration Number: ACTRN12612000202864
• Lead Sponsor: GlaxoSmithKline Nutritional Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

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.
10.Those diagnosed with Phenyketonuria (PKU).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance on the multi-tasking framework (MTF).<br>The computerized MTF comprises four cognitive and psychomotor tasks that are undertaken simultaneously using a 4-way split screen. Responses to all of the tasks are made using the mouse and cursor.[Baseline and at 30 mins post treatment]

Secondary Outcome Measures

Name	Time	Method
Mood as assessed by the following questionnaires:<br>State-Trait Anxiety Inventory<br>Bond-Lader Visual Analogue Mood Scale<br>Stress and fatigue Visual Analogue Mood Scale[Baseline and at 30 mins post treatment];Magnetic Resonance Imaging (MRI) will be used to localise the Blood Oxygen Level Dependent (BOLD) signal and any changes that may come about due to the administration of the drinks.[A subgroup of 20 participants will complete the fMRI component of the study at 60 minutes post dose]