Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001025224
Ethics application status
Approved
Date submitted
23/11/2009
Date registered
25/11/2009
Date last updated
19/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The sub-chronic effects of coffee on cognitive function in a healthy older population
Scientific title
The sub-chronic effects of coffee on cognitive function in a healthy older population
Secondary ID [1] 1155 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effects of coffee on cognition 252176 0
Effects of coffee on mood 252177 0
Cardiovascular function 252178 0
Condition category
Condition code
Diet and Nutrition 252375 252375 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants consume 3 servings of coffee per day for 3 months. Participants will be allocated to one of four types of instant coffee beverages (including one placebo beverage) with varying levels of caffeine in a between-subject, counter-balanced design. Each beverage is 3 g coffee mixed with boiling water and milk if desired.
Intervention code [1] 241538 0
Treatment: Other
Comparator / control treatment
Placebo drink (3 g maltodextrin with coffee flavour)
Control group
Placebo

Outcomes
Primary outcome [1] 253249 0
Speed of attention via reaction time performance on three computerised tasks: simple reaction time, choice reaction time and digit vigilance.
Timepoint [1] 253249 0
at baseline, 1-month post coffee and 3-month post-coffee
Primary outcome [2] 253250 0
Secondary memory via accuracy performance on four separate tasks: immediate word recall, delayed word recall, delayed word recognition and delayed picture recognition.
Timepoint [2] 253250 0
at baseline, 1-month post coffee and 3-month post-coffee
Secondary outcome [1] 262209 0
Accuracy of attention via accuracy performance on the choice reaction time task and digit vigilance task
Timepoint [1] 262209 0
at baseline, 1-month post coffee and 3-month post-coffee
Secondary outcome [2] 262210 0
Memory consisting of a working memory factor score via accuracy on a spatial memory and numeric working memory computerised task and a speed of memory factor score via reaction time on delayed picture recognition, delayed word recognition, numeric working memory and spatial working memory tasks.
Timepoint [2] 262210 0
at baseline, 1-month post coffee and 3-month post-coffee
Secondary outcome [3] 262211 0
Speed of perceputal processing via inspection time on the Inspection Time Task
Timepoint [3] 262211 0
at baseline, 1-month post coffee and 3-month post-coffee
Secondary outcome [4] 262212 0
Concentration and working memory via performance on the computerised serial sevens task
Timepoint [4] 262212 0
at baseline, 1-month post coffee and 3-month post-coffee
Secondary outcome [5] 262213 0
Sustained attention via the Rapid Visual Information Processing task
Timepoint [5] 262213 0
at baseline, 1-month post coffee and 3-month post-coffee
Secondary outcome [6] 262214 0
Stroop interference via the computerised Stroop Colour-Word Test to measure selective attention and cognitive flexibility
Timepoint [6] 262214 0
at baseline, 1-month post coffee and 3-month post-coffee
Secondary outcome [7] 262215 0
Subjective mood via the Profile of Mood States
Timepoint [7] 262215 0
at baseline, 1-month post coffee and 3-month post-coffee
Secondary outcome [8] 262216 0
Arterial blood flow via Doppler ultrasound measurements
Timepoint [8] 262216 0
at baseline, 1-month post coffee and 3-month post-coffee
Secondary outcome [9] 262217 0
Endothelial function via arterial stiffness measurements
Timepoint [9] 262217 0
at baseline, 1-month post coffee and 3-month post-coffee
Secondary outcome [10] 262218 0
Inflammation and oxidative stress via blood samples
Timepoint [10] 262218 0
at baseline, 1-month post coffee and 3-month post-coffee

Eligibility
Key inclusion criteria
Aged 60 and over
Medically and psychiatrically healthy
Light to moderate coffee drinkers
Ability to provide written informed consent
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently taking psychotropic medications, existing psychiatric and neurological conditions, smoker, clinically high blood pressure, allergy to lactose, gluten or wheat

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 treatment was randomly assigned
to the subject by a central randomisation stratification per gender, created off-site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was a randomization stratification per gender provided as a list
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/11/2009
Actual
10/11/2009
Date of last participant enrolment
Anticipated
Actual
5/11/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244007 0
Commercial sector/Industry
Name [1] 244007 0
Nestle Research Centre
Country [1] 244007 0
Switzerland
Primary sponsor type
University
Name
Brain Sciences Institute, Swinburne University of
Address
400 Burwood Road, Hawthorn, Victoria, 3122
Country
Australia
Secondary sponsor category [1] 251358 0
None
Name [1] 251358 0
Address [1] 251358 0
Country [1] 251358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244113 0
Swinburne University Human Research Ethics
Ethics committee address [1] 244113 0
Ethics committee country [1] 244113 0
Australia
Date submitted for ethics approval [1] 244113 0
Approval date [1] 244113 0
08/10/2009
Ethics approval number [1] 244113 0
2009/183

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

Contacts
Principal investigator
Name 30497 0
Prof Con Stough
Address 30497 0
Centre for Human Psychopharmacology (H99)
Swinburne University of Technology
PO Box 218
Hawthorn, Victoria
Australia, 3150
Country 30497 0
Australia
Phone 30497 0
+61 03 9214 8167
Fax 30497 0
Email 30497 0
[email protected]
Contact person for public queries
Name 13744 0
Ms Antoinette Goh
Address 13744 0
Centre for Human Psychopharmacology (H99)
Swinburne University of Technology
PO Box 218
Hawthorn, Victoria
Australia, 3150
Country 13744 0
Australia
Phone 13744 0
+61 3 9214 5094
Fax 13744 0
Email 13744 0
[email protected]
Contact person for scientific queries
Name 4672 0
Professor Con Stough
Address 4672 0
Centre for Human Psychopharmacology (H99)
Swinburne University of Technology
PO Box 218
Hawthorn, Victoria
Australia, 3150
Country 4672 0
Australia
Phone 4672 0
+61 3 9214 8167
Fax 4672 0
Email 4672 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.