Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000959572p
Ethics application status
Not yet submitted
Date submitted
22/07/2024
Date registered
7/08/2024
Date last updated
7/08/2024
Date data sharing statement initially provided
7/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Urolithin A Supplementation on Physical Performance Change in Elite Academy Soccer Athletes Preseason
Scientific title
The Effects of Urolithin A Supplementation on Physical Performance Change in Elite Academy Soccer Athletes Preseason: A Randomised Pilot Trial
Secondary ID [1] 312577 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxidative stress 334590 0
Inflammation 334591 0
Condition category
Condition code
Musculoskeletal 331114 331114 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supplement containing Mitopure -
Sachet containing 1000 mg of Urolithin A (Mitopure) given once per day on each training occasion throughout the six week preseason period. Sachet given with at least 250 mL water dissolved in their usual protein drink supplement. This will be given and supervised by research staff and recorded on each occasion.
Intervention code [1] 329095 0
Treatment: Other
Comparator / control treatment
Placebo
isocaloric, cherry taste matched placebo control (Starburst Zero Sugar). Sachet given with at least 250 mL water dissolved in their usual protein drink supplement. This will be given and supervised by research staff and recorded on each occasion.

Sachet contains citric acid, maltodextrin, aspartame, malic acid, monocalcium phosphate, colours and flavours.
Control group
Placebo

Outcomes
Primary outcome [1] 338873 0
Change in field-based test of maximal aerobic capacity
Timepoint [1] 338873 0
Six weeks (baseline and six weeks post-baseline)
Secondary outcome [1] 437737 0
Urine oxidative stress (this will be composite outcome)
Timepoint [1] 437737 0
Six weeks (baseline and six weeks post-baseline)
Secondary outcome [2] 437738 0
Saliva oxidative stress (this will be composite outcome)
Timepoint [2] 437738 0
Six weeks (baseline and six weeks post-baseline)
Secondary outcome [3] 437739 0
the feasibility of UA supplementation
Timepoint [3] 437739 0
Upon conclusion of the study
Secondary outcome [4] 437740 0
week-to-week changes in subjective stress and fatigue throughout the six-week preseason period
Timepoint [4] 437740 0
Six weeks (weekly during the six week period)
Secondary outcome [5] 437752 0
Change in lower-limb strength production
Timepoint [5] 437752 0
Six weeks (baseline and six weeks post-baseline)
Secondary outcome [6] 437753 0
Change in maximal sprint speed
Timepoint [6] 437753 0
Six weeks (baseline and six weeks post-baseline)
Secondary outcome [7] 437996 0
the acceptability of UA supplementation
Timepoint [7] 437996 0
post-study (final visit at ~6 weeks post-baseline)
Secondary outcome [8] 437997 0
Change in lower-limb power production
Timepoint [8] 437997 0
Six weeks (baseline and six weeks post-baseline)

Eligibility
Key inclusion criteria
We will be seeking players aged between 18-30 years of age (male), who train with the Central Coast Mariners National Premier League team throughout the preseason period (2024-2025). To participate, they must be actively training with, or planning to train with the Mariners throughout the 2024-2025 preseason period, and are required to be free of any medical conditions that may identify them to be at higher risk of injury or discomfort during the activities. Participants should have no pre-existing medical issues that may be worsened because of testing which is part of the research project. This will be determined by the relevant medical professionals within the department (e.g., doctor, physiotherapists). Players who are at higher risk of injury through participation would be flagged as such by the relevant medical professionals (e.g., doctor, physiotherapists) within the department and will not participate.
If a player withdraws from the training environment, or is unavailable for retesting at the end of the preseason period, that information and the reason for that (e.g., injury, signing with another team) will be recorded for descriptive purposes. Players will be given a three day window of availability at the beginning and end of the preseason to have their data recorded through the standard procedures if they are unavailable on the testing date.
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Subjects with diagnosed medical conditions who are unable to participate in training throughout the six week preseason period

- Subjects who are unable to complete the training or testing protocols

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)
The website Sealed Envelope (sealedenvelope.com) will be used for this purpose
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of interventions will be determined through randomisation. The study will use block randomisation with the two conditions (placebo control and supplementation) and block sizes of four. Participants will be randomised and then allocated to the two conditions on a 1:1 basis.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
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
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316974 0
Commercial sector/Industry
Name [1] 316974 0
Central Coast Mariners Football Club
Country [1] 316974 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 319253 0
None
Name [1] 319253 0
None
Address [1] 319253 0
Country [1] 319253 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315729 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 315729 0
Ethics committee country [1] 315729 0
Australia
Date submitted for ethics approval [1] 315729 0
12/08/2024
Approval date [1] 315729 0
Ethics approval number [1] 315729 0

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

Contacts
Principal investigator
Name 135622 0
Dr Mitchell Naughton
Address 135622 0
EXSB204 UoN Ourimbah Campus - 10 Chittaway Rd, Ourimbah NSW 2258
Country 135622 0
Australia
Phone 135622 0
+61 413288621
Fax 135622 0
Email 135622 0
[email protected]
Contact person for public queries
Name 135623 0
Mitchell Naughton
Address 135623 0
EXSB204 UoN Ourimbah Campus - 10 Chittaway Rd, Ourimbah NSW 2258
Country 135623 0
Australia
Phone 135623 0
+61 413288621
Fax 135623 0
Email 135623 0
[email protected]
Contact person for scientific queries
Name 135624 0
Mitchell Naughton
Address 135624 0
EXSB204 UoN Ourimbah Campus - 10 Chittaway Rd, Ourimbah NSW 2258
Country 135624 0
Australia
Phone 135624 0
+61 413288621
Fax 135624 0
Email 135624 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.