Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001216202
Ethics application status
Approved
Date submitted
10/07/2018
Date registered
20/07/2018
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of supplementations with a mitochondrial-targeted antioxidant (MitoQ) and standard antioxidant (Ubiquinol) in healthy adult males
Scientific title
The effect of MitoQ and Ubiquinol antioxidants on human muscle function in healthy adult males
Secondary ID [1] 295484 0
Nil known
Universal Trial Number (UTN)
U1111-1217-0237
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitochondrial function 308747 0
Condition category
Condition code
Musculoskeletal 307682 307682 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be recruited using social media and newspapers, they will then be randomized to consume either MitoQ (1 capsule containing mitoquinol mesylate with a total dose of 20 mg of mitoquinol per day) or Ubiquinol (1 Softgel per day which contains 200 mg of CoQ10) in a double-blind manner for a period of 6 weeks for either supplement separated by a six week washout period and then 6 weeks for another supplement .
Participants will visit the laboratory on four occasions, with a muscle biopsy, 24-hour urine and blood sample being collected at each visit, participants will also be assessed for muscle power/strength production using a dynamometer.
High-resolution respirometry will be used to measure mitochondrial function and reactive oxygen species production. Markers of muscle and blood metabolic state and oxidative status will be measured is blood and muscle samples. MitoQ and Ubiquinol capsules will be provided by MitoQ.
Participants will be asked to remain fasted from the night and provide a 3-day eating record before each visit. They will be asked to return drug tablets leftover after each intervention (a period of 6 weeks for each supplement). They will be also asked to wear a wristband for 5 days which tracks the level of physically active.
Intervention code [1] 301799 0
Treatment: Other
Comparator / control treatment
Active control.
This is a cross-over study where each group will receive either MitoQ or Ubiquinol for 6 weeks followed by 6 weeks washout and then 6 weeks of another supplement.
Control group
Active

Outcomes
Primary outcome [1] 306667 0
Isometric and isotonic knee extension strength measured on a Biodex dynamometer
Timepoint [1] 306667 0
Baseline, 6 weeks post-intervention commencement (first supplement), 6 weeks post-intervention commencement (washout period), 6 weeks post-intervention commencement (second supplement)
Primary outcome [2] 306668 0
Hand grip strength assessed using a dynamometer
Timepoint [2] 306668 0
Baseline, 6 weeks post-intervention commencement (first supplement), 6 weeks post-intervention commencement (washout period), 6 weeks post-intervention commencement (second supplement)
Primary outcome [3] 306670 0
Protein expression in skeletal muscle measured using skeletal muscle biopsies and immunoblotting
Timepoint [3] 306670 0
Baseline, 6 weeks post-intervention commencement (first supplement), 6 weeks post-intervention commencement (washout period), 6 weeks post-intervention commencement (second supplement)
Secondary outcome [1] 349184 0
(Primary outcome) Mitochondrial function from skeletal muscle biopsies measured by high-resolution Oroboros Respirometry
Timepoint [1] 349184 0
Baseline, 6 weeks post-intervention commencement (first supplement), 6 weeks post-intervention commencement (washout period), 6 weeks post-intervention commencement (second supplement)
Secondary outcome [2] 349426 0
(Primary outcome) Gene expression in skeletal muscle using muscle biopsies and real-time PCR analysis
Timepoint [2] 349426 0
Baseline, 6 weeks post-intervention commencement (first supplement), 6 weeks post-intervention commencement (washout period), 6 weeks post-intervention commencement (second supplement)
Secondary outcome [3] 349427 0
(Primary outcome) Glutathione in blood samples measured by using commercially available assay kits
Timepoint [3] 349427 0
Baseline, 6 weeks post-intervention commencement (first supplement), 6 weeks post-intervention commencement (washout period), 6 weeks post-intervention commencement (second supplement)
Secondary outcome [4] 349428 0
(Primary outcome) 8-Iso-Prostaglandin F2a in urine sample measured by using commercially available assay kits
Timepoint [4] 349428 0
Baseline, 6 weeks post-intervention commencement (first supplement), 6 weeks post-intervention commencement (washout period), 6 weeks post-intervention commencement (second supplement)
Secondary outcome [5] 349719 0
(Primary outcome) Reactive oxygen species production from skeletal muscle biopsies measured by high-resolution Oroboros Respirometry
Timepoint [5] 349719 0
Baseline, 6 weeks post-intervention commencement (first supplement), 6 weeks post-intervention commencement (washout period), 6 weeks post-intervention commencement (second supplement)

Eligibility
Key inclusion criteria
Male
40-60 years of age
BMI <32
Sedentary to moderately active (no running, cycling or sport training for more than 3 hours per week or, no more than two resistance training sessions per week)
Healthy
Minimum age
40 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Chronic illness such as cancer, heart disease, diabetes and myopathy
Smoker
Have taken any antioxidant supplements within the previous two 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
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
This will be a single centre study involving 20 participants. Sample size was calculated based on the primary outcome of COX1+2 respiration. Previously our group has observed a 13.54 ± 9.78 pmol/mg/s increase in COX1+2 respiration following short term exercise training. Based on detecting an effect of 67% of this magnitude with 80% power 18 participants would be required. A total n of 20 will be recruited to account of potential participant attrition.
A two-way mixed model with both supplement and time as repeated factors with be used for all primary outcomes

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/07/2018
Actual
26/07/2018
Date of last participant enrolment
Anticipated
Actual
7/12/2018
Date of last data collection
Anticipated
Actual
16/04/2019
Sample size
Target
20
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 10630 0
New Zealand
State/province [1] 10630 0
Auckland

Funding & Sponsors
Funding source category [1] 300071 0
Commercial sector/Industry
Name [1] 300071 0
MitoQ Limited
Country [1] 300071 0
New Zealand
Primary sponsor type
University
Name
Faculty of Medical and 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] 299468 0
None
Name [1] 299468 0
Address [1] 299468 0
Country [1] 299468 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300918 0
Northern A Health and Disability Ethics Committees
Ethics committee address [1] 300918 0
Ethics committee country [1] 300918 0
New Zealand
Date submitted for ethics approval [1] 300918 0
Approval date [1] 300918 0
14/06/2018
Ethics approval number [1] 300918 0
18/NTA/74

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

Contacts
Principal investigator
Name 85274 0
Dr Troy Merry
Address 85274 0
The University of Auckland
The Medical and Health Sciences Building 504
Level 2, Room 201
85 PARK RD
GRAFTON
AUCKLAND 1023
Country 85274 0
New Zealand
Phone 85274 0
+64 9 923 9008
Fax 85274 0
Email 85274 0
[email protected]
Contact person for public queries
Name 85275 0
Troy Merry
Address 85275 0
The University of Auckland
The Medical and Health Sciences Building 504
Level 2, Room 201
85 PARK RD
GRAFTON
AUCKLAND 1023
Country 85275 0
New Zealand
Phone 85275 0
+64 9 923 9008
Fax 85275 0
Email 85275 0
[email protected]
Contact person for scientific queries
Name 85276 0
Troy Merry
Address 85276 0
The University of Auckland
The Medical and Health Sciences Building 504
Level 2, Room 201
85 PARK RD
GRAFTON
AUCKLAND 1023
Country 85276 0
New Zealand
Phone 85276 0
+64 9 923 9008
Fax 85276 0
Email 85276 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
Participant's confidential preference


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.