Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001002279
Ethics application status
Approved
Date submitted
30/09/2009
Date registered
19/11/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of coffee on brain activity and
cognition
Scientific title
The acute effects of coffee on brain activity and cognitive function in a healthy older population
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognition 237095 0
Brain activity 237096 0
Condition category
Condition code
Diet and Nutrition 237417 237417 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants receive four types of instant coffee beverages with varying levels of caffeine over four study visits separated by at least a one week washout period. One coffee beverage is administered per study visit, in a within-subject, crossover study design. Each beverage contains 6g coffee dissolved in 300ml boiling water with milk if desired.
Intervention code [1] 236811 0
Treatment: Other
Comparator / control treatment
Placebo drink (6g maltodextrin with coffee flavour)
Control group
Placebo

Outcomes
Primary outcome [1] 238219 0
Sustained attention via the Rapid Visual Information Processing task. Accuaracy, reaction time and evoked response potential (ERP) components will be measured.
Timepoint [1] 238219 0
at baseline and post-treatment on four separate occasions (visit 1,2,3 and 4)
Secondary outcome [1] 244542 0
Immediate and delayed recall and delayed recognition on the visual verbal learning test
Timepoint [1] 244542 0
at baseline and post-treatment on four separate occasions (visit 1,2,3 and 4)
Secondary outcome [2] 244543 0
Emotion face processing accuracy, reaction time and evoked response potential (ERP) components via a computerised facial expression recognition task.
Timepoint [2] 244543 0
at baseline and post-treatment on four separate occasions (visit 1,2,3 and 4)
Secondary outcome [3] 244544 0
Inspection time on the Inspection time task
Timepoint [3] 244544 0
at baseline and post-treatment on four separate occasions (visit 1,2,3 and 4)
Secondary outcome [4] 244545 0
Stroop interference via the Stroop Colour-Word Test, a pen and paper neuropsychological task.
Timepoint [4] 244545 0
at baseline and post-treatment on four separate occasions (visit 1,2,3 and 4)
Secondary outcome [5] 244546 0
Subjective mood (Bond and Lader visual analogue scale and Caffeine Research visual anlogue scale)
Timepoint [5] 244546 0
at baseline and post-treatment on four separate occasions (visit 1,2,3 and 4)
Secondary outcome [6] 262183 0
Mis-match negativity evoked response potential (ERP) to auditory stimuli
Timepoint [6] 262183 0
at baseline and post-treatment on four separate occasions (visit 1,2,3 and 4)

Eligibility
Key inclusion criteria
Aged 50 and over
Medically and psychiatrically healthy
Light to moderate coffee drinkers
Written informed consent obtained
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinically high blood pressure
Smoker
Currently taking psychotropic medications
Allergy to lactose, gluten or wheat
Hearing impairment

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)
The order of treatment was randomly assigned to the subject by a central randomisation table created off-site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table in four sequences corresponding to a William’s latin square for 4 treatments
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/11/2008
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] 237209 0
Commercial sector/Industry
Name [1] 237209 0
Nestle Research Centre
Country [1] 237209 0
Switzerland
Primary sponsor type
University
Name
Brain Sciences Institute, Swinburne University of Technology
Address
400 Burwood Road, Hawthorn, Victoria, 3122
Country
Australia
Secondary sponsor category [1] 4702 0
None
Name [1] 4702 0
Address [1] 4702 0
Country [1] 4702 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239307 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 239307 0
Ethics committee country [1] 239307 0
Australia
Date submitted for ethics approval [1] 239307 0
Approval date [1] 239307 0
07/10/2008
Ethics approval number [1] 239307 0
2008/028

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

Contacts
Principal investigator
Name 29796 0
Address 29796 0
Country 29796 0
Phone 29796 0
Fax 29796 0
Email 29796 0
Contact person for public queries
Name 13043 0
Dr Vanessa Cropley
Address 13043 0
Brain Sciences Institute
400 Burwood Road
Hawthorn, Victoria 3122
Country 13043 0
Australia
Phone 13043 0
+61 3 9214 5243
Fax 13043 0
Email 13043 0
[email protected]
Contact person for scientific queries
Name 3971 0
Professor Rodney Croft
Address 3971 0
School of Psychology
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 3971 0
Australia
Phone 3971 0
+61 2 4221 3652
Fax 3971 0
Email 3971 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
No additional documents have been identified.