Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000423415
Ethics application status
Approved
Date submitted
31/03/2016
Date registered
4/04/2016
Date last updated
31/10/2022
Date data sharing statement initially provided
4/03/2020
Date results provided
4/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does caffeine consumption influence visual performance?
Scientific title
Effect of caffeine on a visual contrast perception task in young healthy adults
Secondary ID [1] 288889 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vision impairment 298194 0
Condition category
Condition code
Neurological 298353 298353 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty healthy young (18-35 years) adults will be recruited and screened to ensure healthy eyes and vision. The main task is to observe patterns on a computer monitor and make judgments (by pressing a button) about the contrast of a pattern. There will be two test sessions, a treatment session and control session. The order of the sessions will be randomised and the participants blinded to the treatment. Participants will be instructed not to consume caffeine for 12 hours prior to attending each test session. At the beginning of each test session, participants will undergo baseline visual testing. This will be followed by 1) a controlled dose of caffeine in the form of an over-the-counter caffeine + vitamin pill (2 x ‘No Doz Plus’ tablets = 200 mg caffeine + 20 mg thiamine or Vitamin B1 + 20 mg nicotinic acid or Vitamin B3) or 2) a placebo pill. Visual testing will then occur 45 minutes after tablet ingestion. At the second visit at least one week later, participants will undergo the same protocol (caffeine washout, baseline testing, tablet ingestion, post-tablet testing) such that all participants will have consumed both the caffeine pill and placebo pill. The pills are both white, uncoated, round tablets with no engravings of approximately the same size, which will assist in masking the identity of the pill at each test session.
Intervention code [1] 294346 0
Treatment: Drugs
Comparator / control treatment
As a comparator/control treatment, participants will consume a pure vitamin pill (2 x ‘Betamin’ tablets = 200 mg thiamine or Vitamin B1),
Control group
Placebo

Outcomes
Primary outcome [1] 297829 0
Participants will observe a small circular striped patch in the middle of a computer monitor and make judgments (by pressing a button) about the contrast of the pattern. A 'suppression index' will be calculated that compares the contrast judgment before and after treatment.
Timepoint [1] 297829 0
Baseline (prior to treatment) compared to 45 minutes post-tablet ingestion
Secondary outcome [1] 322356 0
None
Timepoint [1] 322356 0
N/A

Eligibility
Key inclusion criteria
1) Visual acuity at least 6/7.5 in both eyes
2) Good general health
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Contraindications for No Doz consumption: high blood pressure, recent heart attack, abnormal heart rhythm, stomach ulcer, inflamed colon and small intestine, severe liver disease, seizures, chronic insomnia, moderate to severe kidney impairment
2) Medications with possible interactions with No Doz and/or Vitamin B: tizanidine (muscle relaxant), digoxin (used to treat heart conditions), diuretics (particularly loop diuretics like furosemide), and phenytoin (used to treat epilepsy).

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)
All participants receive all the interventions (two) in random order during the study.
The random order is assigned by a study coordinator.
Examiners and participants are blinded.
The allocation is concealed by numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) to allocate either 1st or 2nd treatment as first session.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis
We will recruit 20 healthy, young (18-35 years) observers. The effect of caffeine is believed to result in a similar change in brain neurochemical levels as that seen after ingestion of donepezil. Our research hypothesis is based on a previous study (Kosovicheva et al Front Behav Neurosci 2012;6:61) that measured the effect of donepezil on visual performance in a group of healthy, young observers (mean age 26 years), compared to a placebo pill. In that study, a paired t-test (drug vs placebo) found a significant difference in performance following ingestion of donepezil (group mean difference = 1% contrast, standard deviation = 1.3% contrast) in a group of 19 individuals (alpha = 0.05, 2-tailed) with 90% power, rejecting the null hypothesis that the mean difference was 0% contrast. We have rounded this up to 20 participants in each group to find intra-individual differences in visual performance with and without caffeine ingestion.

Data will be analysed using appropriate statistical methods (ANOVA, paired t-tests) in a statistical package.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2016
Actual
26/05/2016
Date of last participant enrolment
Anticipated
31/08/2016
Actual
1/08/2016
Date of last data collection
Anticipated
7/09/2016
Actual
4/08/2016
Sample size
Target
20
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 12994 0
3010 - University Of Melbourne

Funding & Sponsors
Funding source category [1] 293241 0
Government body
Name [1] 293241 0
Australian Research Council Discovery Project DP140100157
Country [1] 293241 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Department of Optometry and Vision Sciences
Level 4 Alice Hoy Building (Building 162) Monash Road
The University of Melbourne, Parkville VIC 3010 Australia
Country
Australia
Secondary sponsor category [1] 292043 0
None
Name [1] 292043 0
Address [1] 292043 0
Country [1] 292043 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294719 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 294719 0
Ethics committee country [1] 294719 0
Australia
Date submitted for ethics approval [1] 294719 0
18/02/2016
Approval date [1] 294719 0
18/05/2016
Ethics approval number [1] 294719 0
HREC #1646382

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

Contacts
Principal investigator
Name 64318 0
Dr Bao Nguyen
Address 64318 0
Department of Optometry and Vision Sciences Level 2, 200 Berkeley Street (Building 260) The University of Melbourne, Parkville VIC 3010
Country 64318 0
Australia
Phone 64318 0
+61 3 9035 8553
Fax 64318 0
Email 64318 0
[email protected]
Contact person for public queries
Name 64319 0
Bao Nguyen
Address 64319 0
Department of Optometry and Vision Sciences Level 2, 200 Berkeley Street (Building 260) The University of Melbourne, Parkville VIC 3010
Country 64319 0
Australia
Phone 64319 0
+61 3 9035 8553
Fax 64319 0
Email 64319 0
[email protected]
Contact person for scientific queries
Name 64320 0
Bao Nguyen
Address 64320 0
Department of Optometry and Vision Sciences Level 2, 200 Berkeley Street (Building 260) The University of Melbourne, Parkville VIC 3010
Country 64320 0
Australia
Phone 64320 0
+61 3 9035 8553
Fax 64320 0
Email 64320 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.