Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000799550p
Ethics application status
Submitted, not yet approved
Date submitted
17/06/2024
Date registered
27/06/2024
Date last updated
27/06/2024
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
Scientific title
Investigating the effect of topical carnosine on rowing performance in club level rowers
Secondary ID [1] 312333 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise Induced Muscle Acidosis 334099 0
Athletic Performance 334117 0
Condition category
Condition code
Musculoskeletal 330773 330773 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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. Approximately 10 mL of topical carnosine will be applied to the participant's back and limb muscles by an experienced researcher ( > 3 years of research experience) 45 minutes before the time trial begins. 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 give 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.
Intervention code [1] 328837 0
Treatment: Other
Intervention code [2] 328897 0
Treatment: Drugs
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.
Control group
Placebo

Outcomes
Primary outcome [1] 338557 0
Change in short distance rowing performance
Timepoint [1] 338557 0
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.
Secondary outcome [1] 436688 0
n/a
Timepoint [1] 436688 0
n/a

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.
Minimum age
17 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Rowers will be excluded if they have used beta-alanine supplementation within 30 days of the first trial.

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)
Randomisation by computer.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 26382 0
New Zealand
State/province [1] 26382 0
Waikato, Bay of plenty, Auckland

Funding & Sponsors
Funding source category [1] 316731 0
University
Name [1] 316731 0
University of Waikato
Country [1] 316731 0
New Zealand
Primary sponsor type
University
Name
University of Waikato
Address
Country
New Zealand
Secondary sponsor category [1] 318939 0
None
Name [1] 318939 0
Address [1] 318939 0
Country [1] 318939 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315506 0
University of Waikato Human Research Ethics Committee (Health)
Ethics committee address [1] 315506 0
https://calendar.waikato.ac.nz/research-assessment-graduation/ethical-conduct
Ethics committee country [1] 315506 0
New Zealand
Date submitted for ethics approval [1] 315506 0
31/05/2024
Approval date [1] 315506 0
Ethics approval number [1] 315506 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134910 0
Mr James Rountree
Address 134910 0
The University of Waikato, Adams Centre for High Performance, 52 Miro Street, Mount Maunganui, 3116 Tauranga
Country 134910 0
New Zealand
Phone 134910 0
+64 221937435
Fax 134910 0
Email 134910 0
jr207@students.waikato.ac.nz
Contact person for public queries
Name 134911 0
James Rountree
Address 134911 0
The University of Waikato, Adams Centre for High Performance, 52 Miro Street, Mount Maunganui, 3116 Tauranga
Country 134911 0
New Zealand
Phone 134911 0
+64 221937435
Fax 134911 0
Email 134911 0
jr207@students.waikato.ac.nz
Contact person for scientific queries
Name 134912 0
James Rountree
Address 134912 0
The University of Waikato, Adams Centre for High Performance, 52 Miro Street, Mount Maunganui, 3116 Tauranga
Country 134912 0
New Zealand
Phone 134912 0
+64 221937435
Fax 134912 0
Email 134912 0
jr207@students.waikato.ac.nz

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.