Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001665820
Ethics application status
Approved
Date submitted
18/08/2021
Date registered
3/12/2021
Date last updated
3/12/2021
Date data sharing statement initially provided
3/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of caffeine on estimates of persistent inward currents in human motor units
Scientific title
The effect of caffeine on estimates of persistent inward currents in healthy human motor units
Secondary ID [1] 305082 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise performance after caffeine consumption 323303 0
Neurotransmitter level imbalance 324319 0
Condition category
Condition code
Musculoskeletal 320868 320868 0 0
Normal musculoskeletal and cartilage development and function
Neurological 321811 321811 0 0
Studies of the normal brain and nervous system
Metabolic and Endocrine 321812 321812 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this project, we will study the effects of caffeine on parameters of motor function. Participants will be asked to visit the laboratory QUT Kelvin Grove for two sessions (one placebo and one intervention visit) of 3 h each. One week wash-out period will separate each visit. On each visit, participants will be given either a placebo or a single dose of Caffeine (oral capsule with 6 mg/kg of body mass) and neuromuscular assessments will be performed before and 60 min after consuming the capsule. All capsules will be prepared by Exercise physiologist with 8 years of research experience. The consumption of capsules will be monitored by the principal investigator.
Intervention code [1] 321477 0
Treatment: Other
Comparator / control treatment
Placebo control: 6 mg/kg of body mass, oral capsule of corn starch (corn flour), One dose prepared by Exercise physiologist with 8 years of research experience. The consumption of the capsule will be monitored by the principal investigator.
Control group
Placebo

Outcomes
Primary outcome [1] 328662 0
Estimates of persistent inward currents (PICs): Measured using high density electromyopgraphy (EMG) placed on the tibialis anterior muscle (front leg), while sitting on a leg dynamometer.
Timepoint [1] 328662 0
At baseline and 60 mins after consumption of capsules (on each visit)
Primary outcome [2] 328663 0
Time to muscle fatigue (TTF): Measured on a leg dynamometer.
Timepoint [2] 328663 0
90 min after consumption of the capsules (on each visit).
Secondary outcome [1] 399868 0
Maximal voluntary contraction (MVC): Measured on a leg dynamometer.
Timepoint [1] 399868 0
At baseline and 60 mins after consumption of capsules (on each visit)
Secondary outcome [2] 399869 0
Rate of force development (RFD): Measured on a leg dynamometer.
Timepoint [2] 399869 0
At baseline and 60 mins after consumption of capsules (on each visit)

Eligibility
Key inclusion criteria
Healthy non-smokers , BMI <30 kg/m2
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Musculoskeletal disorders that limit performance in the assessed limb; diagnosed neurological disorders (e.g. amyotrophic lateral sclerosis or ALS); diagnosed serotonergic disorders (e.g. depression); consumption of drugs that affect serotonin and noradrenaline release (e.g. recreational drugs such as marihuana and ecstasy, SRRIs or antidepressants); Women must not be pregnant, breast feeding or menopausal.

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)
Central randomisation by computer was performed by another researcher from the research team (Lucas Beta Orssatto), who is not involved in data collection or data analysis, will assign an identifying code to each supplement and will arrange which supplement will be consumed during each testing visit.
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/05/2021
Date of last participant enrolment
Anticipated
Actual
31/08/2021
Date of last data collection
Anticipated
Actual
7/09/2021
Sample size
Target
15
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 309480 0
University
Name [1] 309480 0
Queensland University of Technology
Country [1] 309480 0
Australia
Primary sponsor type
Individual
Name
Karen Mackay
Address
Queensland University of Technology
149 Victoria Park Rd, Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 310452 0
Individual
Name [1] 310452 0
Gabriel Trajano
Address [1] 310452 0
Queensland University of Technology
149 Victoria Park Rd, Kelvin Grove QLD 4059
Country [1] 310452 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309267 0
QUT Human Research Ethics Committee
Ethics committee address [1] 309267 0
Ethics committee country [1] 309267 0
Australia
Date submitted for ethics approval [1] 309267 0
20/08/2020
Approval date [1] 309267 0
13/05/2021
Ethics approval number [1] 309267 0
2000000579

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

Contacts
Principal investigator
Name 113558 0
Miss Karen Mackay
Address 113558 0
Queensland University of Technology
Faculty of Health, O block A wing, Room O321
149 Victoria Park Rd, Kelvin Grove QLD 4059
Brisbane, Australia
Country 113558 0
Australia
Phone 113558 0
+61478761076
Fax 113558 0
Email 113558 0
[email protected]
Contact person for public queries
Name 113559 0
Karen Mackay
Address 113559 0
Queensland University of Technology
Faculty of Health, O block A wing, Room O321
149 Victoria Park Rd, Kelvin Grove QLD 4059
Brisbane, Australia
Country 113559 0
Australia
Phone 113559 0
+61478761076
Fax 113559 0
Email 113559 0
[email protected]
Contact person for scientific queries
Name 113560 0
Karen Mackay
Address 113560 0
Queensland University of Technology
Faculty of Health, O block A wing, Room O321
149 Victoria Park Rd, Kelvin Grove QLD 4059
Brisbane, Australia
Country 113560 0
Australia
Phone 113560 0
+61478761076
Fax 113560 0
Email 113560 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12932Study protocol  [email protected]
12933Ethical approval  [email protected]
12934Informed consent form  [email protected]



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.