Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000687695
Ethics application status
Approved
Date submitted
13/06/2023
Date registered
26/06/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
26/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of MitoQ supplementation on skeletal muscle exercise responses in older individuals
Scientific title
The effect of Mitochondria-targeted antioxidant supplementation on the age-related attenuation of muscle responses to exercise in adults aged 65 to 80 years
Secondary ID [1] 309886 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxidative stress 330347 0
Condition category
Condition code
Musculoskeletal 327191 327191 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 327243 327243 0 0
Other physical medicine / rehabilitation

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 consume one MitoQ capsule (containing mitoquinol mesylate equivalent to 20mg mitoquinol) per day orally for 12 weeks. Adherence to the supplement protocol will be monitored via capsule return.

On the day of completion of the 12-week supplementation period, participants in both arms will complete a 20-minute bout of high-intensity interval exercise on a stationary cycle ergometer. Participants will complete 5 x 2-minute bouts of cycling at 80% peak power separated by 2 minutes of cycling at 40% peak power.
Intervention code [1] 326309 0
Treatment: Other
Comparator / control treatment
Participants in the control group (arm 2) will consume one placebo capsule per day orally for 12 weeks. Placebo capsules will be identical to the MitoQ capsules but will contain tapioca powder.
Control group
Placebo

Outcomes
Primary outcome [1] 335071 0
The effect of MitoQ supplementation on mitochondrial reactive oxygen species (ROS) levels measured in skeletal muscle biopsies using fluorimetry
Timepoint [1] 335071 0
Baseline (pre-supplementation) and immediately after completion of the 12-week supplementation period (pre-exercise)
Secondary outcome [1] 422916 0
Mitochondrial respiration measured in skeletal muscle biopsies using high-resolution respirometry
Timepoint [1] 422916 0
Baseline (pre-supplementation) and immediately after completion of the 12-week supplementation period (pre-exercise)
Secondary outcome [2] 422917 0
The effect of MitoQ supplementation on acute exercise-induced gene expression measured in skeletal muscle using PCR
Timepoint [2] 422917 0
Pre-exercise and immediately and 4 hours after exercise following the 12-week supplementation period
Secondary outcome [3] 422918 0
The effect of MitoQ supplementation on acute exercise-induced protein expression measured in skeletal muscle using immunoblotting
Timepoint [3] 422918 0
Pre-exercise and immediately and 4 hours after exercise following the 12-week supplementation period
Secondary outcome [4] 422919 0
The effect of MitoQ supplementation on markers of oxidative stress measured in blood using a colorimetric assay
Timepoint [4] 422919 0
Baseline (pre-supplementation), pre-exercise and 4 hours and 3 days after exercise following the 12-week supplementation period
Secondary outcome [5] 423172 0
The effect of MitoQ supplementation on markers of oxidative stress measured in urine using an enzyme-linked immunosorbent assay
Timepoint [5] 423172 0
Baseline (pre-supplementation), pre-exercise and 4 hours and 3 days after exercise following the 12-week supplementation period

Eligibility
Key inclusion criteria
Aged 65-80 years, sedentary (complete less than 150 mins of moderate intensity exercise per week and have not performed regular physical activity during the previous 6 months), healthy BMI between 18 and 30 kg/m^2, pass the Exercise and Sports Science Australia (ESSA) pre-exercise screening tool and obtain GP clearance to perform high-intensity exercise.
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Acute illness, musculoskeletal, cardiovascular, or neurological disorder that could place the participant at risk of injury or illness resulting from the exercise; coronary heart disease, congestive heart failure, uncontrolled hypertension, diabetes mellitus, bleeding disorder, taking drugs that increase the risk of bleeding or other medications that may impact exercise responses, taking antioxidant supplements in the 6 weeks prior to recruitment, smoking.

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)
Participants will be given the intervention (MitoQ or placebo capsules) in 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
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical power sample size calculations were undertaken using G*Power 3.1 using previously reported effect size changes in skeletal muscle mitochondrial H2O2 levels following MitoQ supplementation. We estimate that a sample size of 10 participants per group will enable the detection of a 0.4 pmol/s/mg reduction in skeletal muscle mitochondrial H2O2 levels following MitoQ supplementation with statistical power of 80% and a significance level of 0.05. To account for possible dropouts and to ensure equal numbers of males and females in each treatment group, we will recruit a total of 24 participants (12 participants per group).

ANOVA or non-parametric tests (where appropriate) 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
Recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
23/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314070 0
University
Name [1] 314070 0
Australian Catholic University
Country [1] 314070 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Level 16, 8-20 Napier Street
North Sydney
NSW 2060
Country
Australia
Secondary sponsor category [1] 315986 0
None
Name [1] 315986 0
Address [1] 315986 0
Country [1] 315986 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313210 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 313210 0
Ethics committee country [1] 313210 0
Australia
Date submitted for ethics approval [1] 313210 0
02/05/2023
Approval date [1] 313210 0
12/07/2023
Ethics approval number [1] 313210 0
2023-2907HC

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

Contacts
Principal investigator
Name 127350 0
Dr Sophie Broome
Address 127350 0
Australian Catholic University
Building 420, Level 5
215 Spring Street
Melbourne
VIC 3000
Country 127350 0
Australia
Phone 127350 0
+61 421717852
Fax 127350 0
Email 127350 0
[email protected]
Contact person for public queries
Name 127351 0
Sophie Broome
Address 127351 0
Australian Catholic University
Building 420, Level 5
215 Spring Street
Melbourne
VIC 3000
Country 127351 0
Australia
Phone 127351 0
+61 421717852
Fax 127351 0
Email 127351 0
[email protected]
Contact person for scientific queries
Name 127352 0
Sophie Broome
Address 127352 0
Australian Catholic University
Building 420, Level 5
215 Spring Street
Melbourne
VIC 3000
Country 127352 0
Australia
Phone 127352 0
+61 421717852
Fax 127352 0
Email 127352 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.