Caffeine/Glucose and Multi-tasking

Completed

• Conditions: Cognitive Function; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12613000247774
• Lead Sponsor: GlaxoSmithKline Nutritional Healthcare Future Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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)

Exclusion Criteria

1.Females who are pregnant, breast-feeding and/or not using a medically approved form of contraception.
2.Any significant concurrent illness including any bleeding disorders, heart conditions, diabetes, glaucoma, high blood pressure or osteoporosis.
3.Individuals who suffer from Diabetes Mellitus.
4.Any known or suspected food allergies (this would cover all ingredients in the investigational product).
5.Susceptible to any unwanted side-effects of caffeine, such as reduction in sleep quality.
6.Smokers and users of recreational drugs (except alcohol and other food grade actives)
7.Have participated in any other study involving an investigational product in the last 4 weeks.
8.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. Responses to all of the tasks are made using the mouse and cursor.[Baseline and 30 mins post dose]

Secondary Outcome Measures

Name	Time	Method
Mood as assessed by the following questionnaires:<br>Profile of Mood States (POMS)<br>Swinburne Emotional Intelligence Test (SUEIT)<br>State-Trait Anxiety Inventory<br>NEO-Five Factor Inventory (NEO-FFI)<br>Bond-Lader Visual Analogue Mood Scale<br>Stress and fatigue Visual Analogue Mood Scale<br>[Baseline and 30 mins post dose];Blood glucose (MediSense Optium Xceed Blood Glucose Sensor and disposable MediSense Blood Glucose Electrodes (MediSense Britain Ltd, Birmingham, UK)[Baseline, 30 mins post dose and 60 mins post dose];Mood/fatigue/stress questionnaires:<br>NASA – TLX Perceived Workload Questionnaire[60 mins post dose];Saliva sample (Salivary caffeine will be measured using a caffeine assay)[Baseline and 60 mins post dose]