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Trial registered on ANZCTR


Registration number
ACTRN12613000247774
Ethics application status
Approved
Date submitted
28/02/2013
Date registered
1/03/2013
Date last updated
1/03/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Caffeine/Glucose and Multi-tasking
Scientific title
An investigation into the effects of two doses of glucose alone and a single dose of caffeine-glucose in combination on cognitive performance, fatigue and mood associated with extended multi-tasking in healthy adults aged 18-55 years
Secondary ID [1] 282047 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Function 288518 0
Condition category
Condition code
Mental Health 288850 288850 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Using a randomised double blind crossover design, up to 160 healthy frequent caffeine consumers will attend 2 sessions (1 practice and 1 test session).

During the practice session participants will complete a battery of cognitive tasks, mood and fatigue ratings. During the test session they will complete a battery of cognitive tasks, mood and fatigue ratings once before and once after receiving either one 330ml drink corresponding to:

1. Placebo - Britvic Tango Orange Sparkling Drink, Diet sugar free fizzy orange drink
2. 25g Glucose - Lucozade energy (International) diluted with Tango orange
3. 60g Glucose - Lucozade energy (International i.e. outside UK)
4. 60g Glucose/40mg Caffeine - Lucozade energy (UK)
Intervention code [1] 286637 0
Treatment: Other
Comparator / control treatment
A placebo will be supplied in the form of an orange flavoured liquid in unlabelled and coded bottles containing 330ml of solution
Control group
Placebo

Outcomes
Primary outcome [1] 288978 0
Performance on the multi-tasking framework (MTF).
The computerized MTF comprises four cognitive and psychomotor tasks. Responses to all of the tasks are made using the mouse and cursor.
Timepoint [1] 288978 0
Baseline and 30 mins post dose
Secondary outcome [1] 301482 0
Mood as assessed by the following questionnaires:
Profile of Mood States (POMS)
Swinburne Emotional Intelligence Test (SUEIT)
State-Trait Anxiety Inventory
NEO-Five Factor Inventory (NEO-FFI)
Bond-Lader Visual Analogue Mood Scale
Stress and fatigue Visual Analogue Mood Scale
Timepoint [1] 301482 0
Baseline and 30 mins post dose
Secondary outcome [2] 301483 0
Blood glucose (MediSense Optium Xceed Blood Glucose Sensor and disposable MediSense Blood Glucose Electrodes (MediSense Britain Ltd, Birmingham, UK)
Timepoint [2] 301483 0
Baseline, 30 mins post dose and 60 mins post dose
Secondary outcome [3] 301484 0
Mood/fatigue/stress questionnaires:
NASA – TLX Perceived Workload Questionnaire
Timepoint [3] 301484 0
60 mins post dose
Secondary outcome [4] 301485 0
Saliva sample (Salivary caffeine will be measured using a caffeine assay)
Timepoint [4] 301485 0
Baseline and 60 mins post dose

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A unique screening number will identify all subjects screened for study participation. Screening numbers will be assigned in ascending numerical order as each subject signs their consent form. Subjects who meet all inclusion and exclusion criteria will be randomised according to the randomisation schedule. Randomisation numbers will be assigned in ascending numerical order according to appearance at the study site on the day subjects are randomised. Participants will be allocated to a treatment by a person not involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This will be achieved using a computerised random number generator which will assign each participant to one of the 4 treatments.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286819 0
Commercial sector/Industry
Name [1] 286819 0
GlaxoSmithKline Nutritional Healthcare Future Group
Address [1] 286819 0
GSK House, AS1
980 Great West Road
Brentford
Middlesex TW8 9GS
UK
Country [1] 286819 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline Nutritional Healthcare Future Group
Address
GSK House, AS1
980 Great West Road
Brentford
Middlesex TW8 9GS
UK
Country
United Kingdom
Secondary sponsor category [1] 285607 0
None
Name [1] 285607 0
Address [1] 285607 0
Country [1] 285607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288885 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 288885 0
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 288885 0
Australia
Date submitted for ethics approval [1] 288885 0
Approval date [1] 288885 0
Ethics approval number [1] 288885 0
2010/299

Summary
Brief summary
This investigation is a single centre, double blind, parallel groups design assessing the effects of two doses of glucose alone and a dose of caffeine- glucose combination on cognitive performance, fatigue, stress and mood associated with extended multi-tasking.

Using a randomised double blind crossover design, up to 160 healthy frequent caffeine consumers will attend 2 sessions (1 practice and 1 test session). During the practice session participants will complete a battery of cognitive tasks, mood and fatigue ratings. During the test session they will complete a battery of cognitive tasks, mood and fatigue ratings once before and once after receiving one drink corresponding to:

1. Placebo - Britvic Tango Orange Sparkling Drink, Diet sugar free fizzy orange drink
2. 25g Glucose - Lucozade energy (International) diluted with Tango orange
3. 60g Glucose - Lucozade energy (International i.e. outside UK)
4. 60g Glucose/40mg Caffeine - Lucozade energy (UK)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38182 0
Prof Andrew Scholey
Address 38182 0
Mail H24, PO Box 218, Swinburne University, Hawthorn VIC 3122
Country 38182 0
Australia
Phone 38182 0
+61392148932
Fax 38182 0
Email 38182 0
ascholey@swin.edu.au
Contact person for public queries
Name 38183 0
Ms Antionette Goh
Address 38183 0
Mail H24, PO Box 218, Swinburne University, Hawthorn VIC 3122
Country 38183 0
Australia
Phone 38183 0
+61392145094
Fax 38183 0
Email 38183 0
agoh@swin.edu.au
Contact person for scientific queries
Name 38184 0
Prof Andrew Scholey
Address 38184 0
Mail H24, PO Box 218, Swinburne University, Hawthorn VIC 3122
Country 38184 0
Australia
Phone 38184 0
+61392148932
Fax 38184 0
Email 38184 0
ascholey@swin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary