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Trial registered on ANZCTR
Registration number
ACTRN12624000799550
Ethics application status
Approved
Date submitted
17/06/2024
Date registered
27/06/2024
Date last updated
28/10/2024
Date data sharing statement initially provided
27/06/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Investigating the effect of topical carnosine on rowing performance
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Scientific title
Investigating the effect of topical carnosine on rowing performance in club level rowers
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Secondary ID [1]
312333
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Exercise Induced Muscle Acidosis
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Athletic Performance
334117
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Condition category
Condition code
Musculoskeletal
330773
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study will use a crossover design. Carnosine is an intracellular pH buffer that naturally exists in skeletal muscle. Exercise performance can be improved by increasing muscle carnosine content via beta-alanine supplementation. A commercially available product, Lactigo, is a topical gel containing carnosine that claims to increase muscle carnosine and improve performance. Lactigo is the topical carnosine to be used in this study. 45 minutes before the time trial begins, each participant will apply approximately 10 mL of topical carnosine to their arms and legs and the researcher will apply the gel to the participant's back. The topical carnosine will be kept in an unidentifiable bottle so the researcher and participant are unaware of which gel is being used (double-blind). The effectiveness of the topical carnosine will be assessed using a 1,500 m rowing ergometer time trial, where the performance measure used will be the total time to row 1,500 m. All participants will complete two time trials in total. The two time trials will be separated by one week to allow for washout. Adherence to the protocol will be assessed using the Borg 20-point rated perceived exertion (RPE) scale to ensure participants give maximal effort on each time trial. Participants will be asked to provide their RPE within 30 seconds of finishing each time trial. An RPE value of 19 or 20 will be required to say that maximal effort was given.
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Intervention code [1]
328837
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Treatment: Other
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Intervention code [2]
328897
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Treatment: Drugs
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Comparator / control treatment
The control treatment for this crossover study will be an ultrasound gel with added menthol. Menthol will be added to mimic the smell of Lactigo. The ultrasound gel will be applied under the same protocol as the topical carnosine.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Change in short distance rowing performance
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Assessment method [1]
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1,500 m rowing ergometer time trial result (total time taken to row 1,500 m on a rowing ergometer).
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Timepoint [1]
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Participants will complete two, 1500 m rowing ergometer time trials separated by one week (one trial with topical carnosine and one trial with placebo). Participant performance will be assessed at the end of each time trial, using the total time taken to row 1,500 m. Comparison between trials one and two can be made after the second time trial is completed.
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Secondary outcome [1]
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n/a
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Assessment method [1]
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n/a
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Timepoint [1]
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n/a
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Eligibility
Key inclusion criteria
Sixteen club-level rowers will be recruited for this study. Volunteers will be eligible if they are an experienced rower ( > 3 years rowing) aged 17 – 30 years, and have not used beta-alanine supplementation within 30 days of the first testing session. Both males and females are eligible to take part in this study.
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Minimum age
17
Years
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Maximum age
30
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Rowers will be excluded if they have used beta-alanine supplementation within 30 days of the first trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation. The participants will be separated into males and females to ensure an even spread in each group. From this point, participants will be assigned a group using randomisation software on a computer program.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
27/08/2024
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Actual
23/08/2024
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Date of last participant enrolment
Anticipated
15/11/2024
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Actual
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Date of last data collection
Anticipated
15/12/2024
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Actual
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Sample size
Target
16
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Accrual to date
8
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Final
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Recruitment outside Australia
Country [1]
26382
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New Zealand
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State/province [1]
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Waikato, Bay of plenty, Auckland
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Waikato
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Address [1]
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Country [1]
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New Zealand
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Primary sponsor type
University
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Name
University of Waikato
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
318939
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Country [1]
318939
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315506
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University of Waikato Human Research Ethics Committee (Health)
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Ethics committee address [1]
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https://calendar.waikato.ac.nz/research-assessment-graduation/ethical-conduct
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Ethics committee country [1]
315506
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New Zealand
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Date submitted for ethics approval [1]
315506
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31/05/2024
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Approval date [1]
315506
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06/08/2024
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Ethics approval number [1]
315506
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HREC(Health)2024#29
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Summary
Brief summary
Carnosine naturally exists in skeletal muscle. Elevating the carnosine content in skeletal muscle can improve performance in short-duration, high-intensity exercise, by increasing intracellular pH buffering capacity and improving the contractile ability of skeletal muscle. Beta-alanine supplementation is the most common method to increase muscle carnosine but requires a loading phase of approximately four weeks. Topical carnosine (a carnosine gel applied to the skin) is an alternative method to increase muscle carnosine content and does not require a loading phase. We aim to investigate the effect of topical carnosine on 1,500 m rowing ergometer performance in club-level rowers. We expect the participants to have a small improvement in 1,500 m performance when topical carnosine is used.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr James Rountree
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Address
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The University of Waikato, Adams Centre for High Performance, 52 Miro Street, Mount Maunganui, 3116 Tauranga
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Country
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New Zealand
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Phone
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+64 221937435
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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James Rountree
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Address
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The University of Waikato, Adams Centre for High Performance, 52 Miro Street, Mount Maunganui, 3116 Tauranga
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Country
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New Zealand
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Phone
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+64 221937435
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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James Rountree
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Address
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The University of Waikato, Adams Centre for High Performance, 52 Miro Street, Mount Maunganui, 3116 Tauranga
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Country
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New Zealand
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Phone
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+64 221937435
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Fax
134912
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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