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Trial registered on ANZCTR
Registration number
ACTRN12618000238279
Ethics application status
Approved
Date submitted
1/02/2018
Date registered
14/02/2018
Date last updated
24/04/2020
Date data sharing statement initially provided
18/03/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of supplementation with a mitochondrial-targeted antioxidant (MitoQ) on training induced adaptations and sport performance in healthy adult males.
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Scientific title
The effect of MitoQ(TM) supplementation on muscle biomarkers and sport performance in healthy adult males.
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Secondary ID [1]
293935
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Nil known
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Universal Trial Number (UTN)
U1111-1201-8005
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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:
mitochondrial function
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Condition category
Condition code
Musculoskeletal
305519
305519
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0
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Normal musculoskeletal and cartilage development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study contains two arms; treatment (Arm 1) and placebo (Arm 2). Participants in Arm 1 will be asked to consume one MitoQ oral capsule (containing mitoquinol mesylate equivalent to 20mg mitoquinol) per day for 5 weeks. Adherence to the supplement protocol will be monitored via tablet return.
Participants in both arms will undergo high intensity interval exercise training. Participants will be asked to come to the University of Auckland Grafton campus to complete 10 face-to-face training sessions over a period of 3 weeks, which will be supervised by the researcher. During the first week participants will complete 3 sessions of 8 repeated 60s intervals of high-intensity stationary cycling (at 100% peak power output determined from VO2max test) with 75 s of recovery between each repetition .Training sessions in the first week are expected to last around 30 minutes, including a 5 minute warm-up and 5 minute cool down. During the second week participants will complete 3 sessions of 10 repeated 60s intervals of high-intensity stationary cycling (at 100% peak power output determined from VO2max test) with 75 s of recovery between each repetition. Training sessions in the second week are expected to last around 35 minutes, including a 5 minute warm-up and 5 minute cool down. During the third week participants will complete 4 sessions of 12 repeated 60 s intervals of high-intensity stationary cycling (at 100% peak power output determined from VO2max test) with 75 s of recovery between each repetition. Training sessions in the third week are expected to last around 40 minutes, including a 5 minute warm-up and 5 minute cool down. Training sessions will be separated by at least one day and no more than 4 days,
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Intervention code [1]
300201
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Treatment: Other
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Comparator / control treatment
Participants in the control group will be asked to consume one oral capsule per day for 5 weeks. Placebo control will be identical capsules containing inert, edible powder (cornstarch).
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Control group
Placebo
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Outcomes
Primary outcome [1]
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The effect of MitoQ supplementation on exercise performance measured by change in time to complete a 500 kj work trial on a stationary cycle ergometer
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Assessment method [1]
304643
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Timepoint [1]
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5 weeks post commencement of intervention (supplementation)
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Primary outcome [2]
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The effect of MitoQ supplementation on reduced glutathione/oxidised glutathione ratio in blood samples using commercially available assay kits.
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Assessment method [2]
304715
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Timepoint [2]
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5 weeks post commencement of intervention (supplementation)
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Primary outcome [3]
304716
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The effect of MitoQ supplementation on protein expression in skeletal muscle measured using skeletal muscle biopsies and immunoblotting.
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Assessment method [3]
304716
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Timepoint [3]
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5 weeks post commencement of intervention (supplementation)
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Secondary outcome [1]
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(Primary outcome) The effect of MitoQ supplementation on gene expression in skeletal muscle using muscle biopsies and real time PCR analysis
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Assessment method [1]
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Timepoint [1]
342657
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5 weeks post commencement of intervention (supplementation)
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Secondary outcome [2]
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(Primary outcome) The effect of MitoQ supplementation on VO2 max measured during a maximal exercise test on a cycle ergometer
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Assessment method [2]
343030
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Timepoint [2]
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5 weeks post commencement of intervention (supplementation)
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Eligibility
Key inclusion criteria
Male
35-60 years
Sedentary to moderately active (no running or cycle training and no more than 3 hours of sport per week. No more than 2 resistance training sessions per week)
Healthy
BMI between 20 and 30
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Minimum age
35
Years
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Maximum age
60
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Any chronic or advance health conditions or injuries
History of alcohol abuse
Smoking
Taking medications which may affect exercise responses
Antioxidant supplement intake in the previous 2 months
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Study design
Purpose of the study
Prevention
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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)
Numbered containers
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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)
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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
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
Based on performance data generated in our laboratory, there was an average 9% increase in v02max with and SD of 2.7, the current study is powered to detect a 30% difference in the increases in VO2max (11.76% increase) with 15 subjects per group and 80% power. Appropriate recruitment will allow for drop outs.
ANOVA or non-parametric tests where appropriate and followed up with post-hoc tests will be used to determine differences in end points. Significance will be accepted at P<0.05.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/03/2018
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Actual
15/03/2018
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Date of last participant enrolment
Anticipated
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Actual
1/04/2019
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Date of last data collection
Anticipated
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Actual
27/05/2019
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Sample size
Target
30
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Accrual to date
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Final
25
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Recruitment outside Australia
Country [1]
9544
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
298563
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Commercial sector/Industry
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Name [1]
298563
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MitoQ Limited
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Address [1]
298563
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PO Box 1671
Shortland Street
Auckland
1140
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Country [1]
298563
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New Zealand
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Primary sponsor type
University
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Name
Faculty of Medical Health Sciences, The University of Auckland
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Address
Faculty of Medical and Health Sciences
The University of Auckland
85 Park Rd, Grafton
Auckland 1023
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Country
New Zealand
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Callaghan Innovation
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Address [1]
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PO Box 11529
Manners Street
Wellington 6142
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Country [1]
297711
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299530
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Health and Disability Ethics Committees
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Ethics committee address [1]
299530
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Ministry of Health 133 Molesworth Street PO Box 5013 Wellington 6011
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Ethics committee country [1]
299530
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New Zealand
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Date submitted for ethics approval [1]
299530
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Approval date [1]
299530
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01/12/2017
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Ethics approval number [1]
299530
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17/STH/200
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Summary
Brief summary
The purpose of this study is to evaluate the effect of MitoQ supplementation on exercise training induced adaptations and exercise performance. Furthermore, the study aims to evaluate the effect of MitoQ supplementation on the cellular signalling response to a single bout of exercise and biomarkers which can be used to assess skeletal muscle and metabolic health following multiple (training) bouts of high intensity interval exercise. Finally, the study will enable the researchers to identify novel biomarkers which can be used to assess skeletal muscle and metabolic health, and the response to high intensity interval exercise. We hypothesise that multiple (training) sessions of high intensity interval exercise will improve exercise performance and this will be enhanced by MitoQ supplementation. Furthermore, enhanced exercise performance in the MitoQ supplemented group will be associated with elevated cellular signalling and biomarkers of skeletal muscle and metabolic health.
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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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Dr Troy Merry
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Address
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Medical and Health Sciences Building 504
Level 2, Room 201
85 PARK RD
GRAFTON
AUCKLAND 1023
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Country
80742
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New Zealand
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Phone
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+64 9 923 9008
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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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Troy Merry
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Address
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Medical and Health Sciences Building 504
Level 2, Room 201
85 PARK RD
GRAFTON
AUCKLAND 1023
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Country
80743
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New Zealand
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Phone
80743
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+64 9 923 9008
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Fax
80743
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Email
80743
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[email protected]
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Contact person for scientific queries
Name
80744
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Troy Merry
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Address
80744
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Medical and Health Sciences Building 504
Level 2, Room 201
85 PARK RD
GRAFTON
AUCKLAND 1023
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Country
80744
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New Zealand
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Phone
80744
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+64 9 923 9008
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Fax
80744
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Email
80744
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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
Results will be reported as means and SDs
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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
Source
Title
Year of Publication
DOI
Embase
MitoQ supplementation augments acute exercise-induced increases in muscle PGC1alpha mRNA and improves training-induced increases in peak power independent of mitochondrial content and function in untrained middle-aged men.
2022
https://dx.doi.org/10.1016/j.redox.2022.102341
N.B. These documents automatically identified may not have been verified by the study sponsor.
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