Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000202864
Ethics application status
Approved
Date submitted
25/01/2012
Date registered
17/02/2012
Date last updated
16/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation into the effects of glucose and caffeine on multitasking, mood and fMRI
Scientific title
An investigation into the effects of glucose and caffeine on multitasking, mood and fMRI regional activation in healthy adults.
Secondary ID [1] 279797 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function in healthy adults 285676 0
neural activation in healthy adults 285677 0
Condition category
Condition code
Alternative and Complementary Medicine 285861 285861 0 0
Other alternative and complementary medicine
Mental Health 285862 285862 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 285863 285863 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will employ a double blind, randomised, placebo controlled, four way cross-over design.

Participants will be required to attend one practice session followed by four testing sessions.
During the practice session particpants will sign the consent form and practice the multi-tasking assessment and be familiarised with the mood scales and other procedures.

The testing sessions will see participants taking one of four interventions:

(1) Caffeine drink (40mg caffeine)
(2) Caffeine and Glucose Drink (25mg Glucose, 40mg caffeine)
(3) Caffeine and Glucose Drink (60mg Glucose, 40mg caffeine)
(4) Placebo

All four treatments will be administered as carbonated drinks and will be matched for colour, smell and taste.

On the testing days participants will complete baseline testing (consisting of the multitasking framework, mood) after which they will be administered their randomly assigned treatment. 30 minutes post dose participant will complete the testing again (multitasking framework, mood).

20 participants will additionally complete the fMRI component which will take an additional hour and a half at the end of each treatment arm (60 minutes post dose). Once in the scanner participants will have a structural scan followed by the functional scans in which they will complete two cognitive tasks.

There will be a seven day washout period between each testing session.

Participants will be randomly allocated to receive either treatment (1) or (2) or (3) or (4) on their first testing day. This will be done by a randomised computer number sequence generator. Over the course of the investigation, they will complete all four treatments with treatment order counterbalanced across participants. A disinterested third party will be responsible for the blinding procedure.
Intervention code [1] 284120 0
Treatment: Other
Comparator / control treatment
Placebo carbonated drink matched for colour, smell and taste
Control group
Placebo

Outcomes
Primary outcome [1] 286361 0
Performance on the multi-tasking framework (MTF).
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.
Timepoint [1] 286361 0
Baseline and at 30 mins post treatment
Secondary outcome [1] 295676 0
Mood as assessed by the following questionnaires:
State-Trait Anxiety Inventory
Bond-Lader Visual Analogue Mood Scale
Stress and fatigue Visual Analogue Mood Scale
Timepoint [1] 295676 0
Baseline and at 30 mins post treatment
Secondary outcome [2] 295677 0
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.
Timepoint [2] 295677 0
A subgroup of 20 participants will complete the fMRI component of the study at 60 minutes post dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated using computer software and will also be stratified for subjects performing the fMRI:- The two strata will be :-
i) Subjects undergoing fMRI
ii) Subjects NOT undergoing fMRI
A randomisation schedule will be prepared for each strata and will be provided by the Biostatistics Department, GSKCH.
.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The investigation will employ a single centre, double-blind, placebo controlled, four-way cross over design. Participants will be randomly allocated to a treatment sequence and will cycle through the 4 study treatments in the order specified in the randomisation schedule.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284575 0
Commercial sector/Industry
Name [1] 284575 0
GlaxoSmithKline Nutritional Healthcare
Country [1] 284575 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline Nutritional Healthcare
Address
GSK House, AS1
980 Great West Road
Brentford
Middlesex TW8 9GS
UK
Country
United Kingdom
Secondary sponsor category [1] 283492 0
None
Name [1] 283492 0
Address [1] 283492 0
Country [1] 283492 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286560 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 286560 0
Ethics committee country [1] 286560 0
Australia
Date submitted for ethics approval [1] 286560 0
Approval date [1] 286560 0
11/11/2011
Ethics approval number [1] 286560 0
SUHREC Project 2011/251

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33681 0
Address 33681 0
Country 33681 0
Phone 33681 0
Fax 33681 0
Email 33681 0
Contact person for public queries
Name 16928 0
Rebecca King
Address 16928 0
H24, Po Box 218
Hawthorn, Vic, 3122
Country 16928 0
Australia
Phone 16928 0
613 92145087
Fax 16928 0
Email 16928 0
[email protected]
Contact person for scientific queries
Name 7856 0
Professor Andrew Scholey
Address 7856 0
H24, Po Box 218
Hawthorn, Vic, 3122
Country 7856 0
Australia
Phone 7856 0
613 9214 8932
Fax 7856 0
Email 7856 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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