Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000885190
Ethics application status
Approved
Date submitted
27/05/2019
Date registered
21/06/2019
Date last updated
13/03/2020
Date data sharing statement initially provided
21/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Caffeine and anaerobic exercise performance: an exploration of caffeine’s effects on performance in young men and the influence of genotype on the variation in responses
Scientific title
The effect of CYP1A2 genotype on the ergogenic effects of caffeine during anaerobic exercise
Secondary ID [1] 298301 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise performance 312931 0
Condition category
Condition code
Musculoskeletal 311422 311422 0 0
Normal musculoskeletal and cartilage development and function
Metabolic and Endocrine 311638 311638 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Caffeine supplementation.
Dose: 3 mg per kg of body weight
The duration of administration: only on one occasion.
Mode of administration: oral tablet.
Wash out period between the caffeine and placebo conditions is from 4 to 7 days.
The CYP1A2 genotype will be assessed using a buccal swab sample collected before the caffeine and placebo conditions.
Intervention code [1] 314536 0
Other interventions
Comparator / control treatment
Placebo,
Composition of the placebo treatment: glucose capsule,
Control group
Placebo

Outcomes
Primary outcome [1] 320143 0
Primary Outcome 1: vertical jump height and power assessed using a countermovement jump on a force platform.
Timepoint [1] 320143 0
One hour post caffeine and placebo ingestion.
Primary outcome [2] 320340 0
Primary Outcome 2: barbell velocity in the bench press exercise assessed using linear position transducers.
Timepoint [2] 320340 0
One hour post caffeine and placebo ingestion.
Primary outcome [3] 320341 0
Primary Outcome 3: maximal number of repetitions in an upper-body muscle endurance test.
Timepoint [3] 320341 0
One hour post caffeine and placebo ingestion.
Secondary outcome [1] 370691 0
Secondary Outcome 1: side-effects to caffeine ingestion such as tachycardia, self-reported by the participants.
Timepoint [1] 370691 0
Immediately post testing and upon waking up in the morning after testing.
Secondary outcome [2] 371274 0
Primary Outcome 4: mean and peak power in the Wingate test.
Timepoint [2] 371274 0
One hour post caffeine and placebo ingestion.

Eligibility
Key inclusion criteria
The sample size will consist of resistance-trained men. Resistance-trained men will be defined as having a minimum of 6 months of resistance training experience with a minimum weekly training frequency of two times on most weeks.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria will be: (1) current smoker; (2) prior or current use of anabolic steroids; and (3) existence of health limitations.

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)
Allocation is not concealed.
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)
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 0
Type of endpoint/s
Efficacy
Statistical methods / analysis
In order to calculate the sample size, we used the G*Power software, version 3.1. The expected effect size was 0.25, which is the average effect size across all meta-analyses that examined the effects of caffeine on exercise performance (Grgic et al. 2019). Here, the alpha error level was set at 0.05 and the statistical power was at 80%. The correlation between repeated measures was set at 0.75 which was determined by our previously published data (Grgic and Mikulic, 2017) and previous review papers (Polito et al., 2016). Based on this power analysis, the total required sample size for this study is 18 participants. Two-way ANOVAs (experimental treatment x genotype group) will be done for the analysis of the data. In addition, absolute and relative effect sizes (i.e. absolute differences between means and Cohen’s d values, respectively) will be calculated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2019
Actual
1/08/2019
Date of last participant enrolment
Anticipated
1/03/2020
Actual
25/11/2019
Date of last data collection
Anticipated
1/04/2020
Actual
30/11/2019
Sample size
Target
18
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 26560 0
3011 - Footscray
Recruitment postcode(s) [2] 26561 0
3032 - Maribyrnong

Funding & Sponsors
Funding source category [1] 302843 0
University
Name [1] 302843 0
Victoria University
Country [1] 302843 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
PO Box 14428, Melbourne, Vic 8001, Australia; Street address: Footscray Park Campus, Ballarat Road, Footscray 3011
Country
Australia
Secondary sponsor category [1] 302791 0
None
Name [1] 302791 0
Address [1] 302791 0
Country [1] 302791 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303421 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 303421 0
Ethics committee country [1] 303421 0
Australia
Date submitted for ethics approval [1] 303421 0
27/02/2019
Approval date [1] 303421 0
01/07/2019
Ethics approval number [1] 303421 0

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

Contacts
Principal investigator
Name 93622 0
Prof David Bishop
Address 93622 0
Victoria University, Melbourne Footscray Park Campus | Ballarat Road | Footscray VIC 3001 PO Box 14428
Country 93622 0
Australia
Phone 93622 0
+61 0435 962 364
Fax 93622 0
Email 93622 0
[email protected]
Contact person for public queries
Name 93623 0
Jozo Grgic
Address 93623 0
Victoria University, Melbourne Footscray Park Campus | Ballarat Road | Footscray VIC 3001 PO Box 14428
Country 93623 0
Australia
Phone 93623 0
+61 0459337908
Fax 93623 0
Email 93623 0
[email protected]
Contact person for scientific queries
Name 93624 0
Jozo Grgic
Address 93624 0
Victoria University, Melbourne Footscray Park Campus | Ballarat Road | Footscray VIC 3001 PO Box 14428
Country 93624 0
Australia
Phone 93624 0
+61 0459337908
Fax 93624 0
Email 93624 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All data.

What types of analyses could be done with individual participant data?
• Only to achieve the aims in the approved proposal.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Individual participant data will be available based on a request to the corresponding author.

Are there extra considerations when requesting access to individual participant data?
No


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.