Trial Review

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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.
Scientific title
The effect of MitoQ(TM) supplementation on muscle biomarkers and sport performance in healthy adult males.
Secondary ID [1] 293935 0
Nil known
Universal Trial Number (UTN)
U1111-1201-8005
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mitochondrial function 306424 0
Condition category
Condition code
Musculoskeletal 305519 305519 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
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,
Intervention code [1] 300201 0
Treatment: Other
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).
Control group
Placebo

Outcomes
Primary outcome [1] 304643 0
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
Timepoint [1] 304643 0
5 weeks post commencement of intervention (supplementation)
Primary outcome [2] 304715 0
The effect of MitoQ supplementation on reduced glutathione/oxidised glutathione ratio in blood samples using commercially available assay kits.
Timepoint [2] 304715 0
5 weeks post commencement of intervention (supplementation)
Primary outcome [3] 304716 0
The effect of MitoQ supplementation on protein expression in skeletal muscle measured using skeletal muscle biopsies and immunoblotting.
Timepoint [3] 304716 0
5 weeks post commencement of intervention (supplementation)
Secondary outcome [1] 342657 0
(Primary outcome) The effect of MitoQ supplementation on gene expression in skeletal muscle using muscle biopsies and real time PCR analysis
Timepoint [1] 342657 0
5 weeks post commencement of intervention (supplementation)
Secondary outcome [2] 343030 0
(Primary outcome) The effect of MitoQ supplementation on VO2 max measured during a maximal exercise test on a cycle ergometer
Timepoint [2] 343030 0
5 weeks post commencement of intervention (supplementation)

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
Minimum age
35 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2018
Actual
15/03/2018
Date of last participant enrolment
Anticipated
Actual
1/04/2019
Date of last data collection
Anticipated
Actual
27/05/2019
Sample size
Target
30
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 9544 0
New Zealand
State/province [1] 9544 0
Auckland

Funding & Sponsors
Funding source category [1] 298563 0
Commercial sector/Industry
Name [1] 298563 0
MitoQ Limited
Country [1] 298563 0
New Zealand
Primary sponsor type
University
Name
Faculty of Medical Health Sciences, The University of Auckland
Address
Faculty of Medical and Health Sciences
The University of Auckland
85 Park Rd, Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 297711 0
Commercial sector/Industry
Name [1] 297711 0
Callaghan Innovation
Address [1] 297711 0
PO Box 11529
Manners Street
Wellington 6142
Country [1] 297711 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299530 0
Health and Disability Ethics Committees
Ethics committee address [1] 299530 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 299530 0
New Zealand
Date submitted for ethics approval [1] 299530 0
Approval date [1] 299530 0
01/12/2017
Ethics approval number [1] 299530 0
17/STH/200

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80742 0
Dr Troy Merry
Address 80742 0
Medical and Health Sciences Building 504
Level 2, Room 201
85 PARK RD
GRAFTON
AUCKLAND 1023
Country 80742 0
New Zealand
Phone 80742 0
+64 9 923 9008
Fax 80742 0
Email 80742 0
[email protected]
Contact person for public queries
Name 80743 0
Troy Merry
Address 80743 0
Medical and Health Sciences Building 504
Level 2, Room 201
85 PARK RD
GRAFTON
AUCKLAND 1023
Country 80743 0
New Zealand
Phone 80743 0
+64 9 923 9008
Fax 80743 0
Email 80743 0
[email protected]
Contact person for scientific queries
Name 80744 0
Troy Merry
Address 80744 0
Medical and Health Sciences Building 504
Level 2, Room 201
85 PARK RD
GRAFTON
AUCKLAND 1023
Country 80744 0
New Zealand
Phone 80744 0
+64 9 923 9008
Fax 80744 0
Email 80744 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
Results will be reported as means and SDs


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
SourceTitleYear of PublicationDOI
EmbaseMitoQ 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.2022https://dx.doi.org/10.1016/j.redox.2022.102341
N.B. These documents automatically identified may not have been verified by the study sponsor.