Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001089921
Ethics application status
Approved
Date submitted
28/08/2020
Date registered
20/10/2020
Date last updated
20/10/2020
Date data sharing statement initially provided
20/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of MitoQ supplementation on muscle recovery following exercise in men
Scientific title
Effect of mitochondria-targeted antioxidant supplementation on the recovery of muscle function and soreness following eccentric exercise in men
Secondary ID [1] 301251 0
None
Universal Trial Number (UTN)
U1111-1251-8877
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise-induced oxidative stress 317427 0
Condition category
Condition code
Physical Medicine / Rehabilitation 315521 315521 0 0
Other physical medicine / rehabilitation
Musculoskeletal 317144 317144 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a parallel design study and participants will be randomly assigned to the MitoQ and placebo groups. Participants in the MitoQ group will consume one oral tablet containing 20 mg mitoquinol per day, for three weeks. Participants in the placebo group will also consume one oral tablet per day for three weeks, which will not contain mitoquinol. Following two weeks of supplementation with either MitoQ or placebo tablets, participants will complete a bout of eccentric exercise using their knee extensor muscles on their dominant leg. Participants will perform 300 (20 sets of 15 repetitions separated by 30 seconds of rest) eccentric contractions using an isokinetic dynamometer and the exercise session will last 35 minutes. Participants will record their dietary intake using a food diary the day before, day of and day after the exercise bout. Participants will also collect all urine produced the day before, day of and day after exercise. Measures of muscle function and soreness will be measured before, immediately after, and 2, 24, 48, 72 and 168 hours post-exercise. Markers of exercise-induced oxidative stress will be measured in plasma samples collected before exercise and immediately and 2 hours post-exercise. Markers of exercise-induced oxidative stress will also be measured in urine samples collected the day before, day of and day after exercise. Adherence to the supplementation protocol will be measured by oversupplying the participants with tablets and counting how many are returned at the end of the trial.
Intervention code [1] 317554 0
Prevention
Comparator / control treatment
Identical placebo tablet containing tapioca powder, precipitated silica and microcrystalline cellulose 101
Control group
Placebo

Outcomes
Primary outcome [1] 323763 0
Peak knee extensor isometric torque, measured using an isokinetic dynamometer
Timepoint [1] 323763 0
Peak knee extensor isometric torque will be measured before, immediately after and 2, 24, 48, 72 and 168 hours after completion of the exercise. The primary time point for measurement of peak isometric torque will be 24 hours post-exercise.
Primary outcome [2] 323764 0
Muscle soreness measured using a visual analogue scale
Timepoint [2] 323764 0
Muscle soreness will be measured before, immediately after and 2, 24, 48, 72 and 168 hours after completion of the exercise. The primary time point for measurement of muscle soreness will be 48 hours post-exercise.
Secondary outcome [1] 386314 0
Oxidative stress levels assessed by plasma protein carbonyls
Timepoint [1] 386314 0
Plasma protein carbonyls will be measured in plasma samples collected before exercise and immediately and 2 hours post-exercise
Secondary outcome [2] 387229 0
Markers of exercise-induced oxidative stress measured by urine F2-isoprostanes
Timepoint [2] 387229 0
Urine F2-isoprostanes will be measured in urine samples collected the day before exercise, the day of exercise and the day after exercise
Secondary outcome [3] 387230 0
Peak knee extensor concentric torque measured using an isokinetic dynamometer
Timepoint [3] 387230 0
Peak knee extensor concentric torque will be measured before, immediately after and 2, 24, 48, 72 and 168 hours after completion of the exercise.
Secondary outcome [4] 387231 0
Peak knee extensor eccentric torque measured using an isokinetic dynamometer
Timepoint [4] 387231 0
Peak knee extensor eccentric torque will be measured before, immediately after and 2, 24, 48, 72 and 168 hours after completion of the exercise.
Secondary outcome [5] 387232 0
Vertical jump height measured using a Vertec
Timepoint [5] 387232 0
Vertical jump height will be measured before, immediately after and 2, 24, 48, 72 and 168 hours after completion of the exercise.

Eligibility
Key inclusion criteria
Male
20-35 years
Sedentary to moderately active (no regular lower body resistance training in the previous 6 months)
BMI between 18.5 and 30 kg/m2
Minimum age
20 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergies to nutritional supplement
Taking medications which may affect exercise responses
Any chronic or advance health conditions or injuries
Smoking
Antioxidant supplement intake within the previous 2 months
Chronic disease

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)
Methods used to generate the sequence in which subjects will be randomised (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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2020
Date of last participant enrolment
Anticipated
1/06/2021
Actual
Date of last data collection
Anticipated
22/06/2021
Actual
Sample size
Target
34
Accrual to date
12
Final
Recruitment outside Australia
Country [1] 22550 0
New Zealand
State/province [1] 22550 0
Auckland

Funding & Sponsors
Funding source category [1] 305698 0
Commercial sector/Industry
Name [1] 305698 0
Callaghan Innovation
Country [1] 305698 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland Research Office
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 306115 0
None
Name [1] 306115 0
Address [1] 306115 0
Country [1] 306115 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305976 0
Northern B Health & Disability Ethics Committee
Ethics committee address [1] 305976 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 305976 0
New Zealand
Date submitted for ethics approval [1] 305976 0
18/03/2019
Approval date [1] 305976 0
21/05/2019
Ethics approval number [1] 305976 0
19/NTB/40

Summary
Brief summary
The study is a randomised, double-blind, parallel design, placebo-controlled study. The intervention will involve the consumption of MitoQ. Participants will be asked to visit the University of Auckland Grafton Campus on 6 occasions over a 3 week period.

During visit 1, participants will have the study and PIS explained to them by the researcher and informed consent to participate in the trial will be obtained from those who meet the inclusion/exclusion criteria. Participants will be asked to complete a questionnaire to obtain a history of exercise and health and determine their eligibility to participate in the study. Participants will also be familiarised to the isokinetic dynamometer.

Participants will be randomly assigned to receive one tablet per day containing either MitoQ (20 mg mitoquinol) or a placebo (tapioca powder, precipitated silica and microcrystalline cellulose 101) for 3 weeks.

Following 2 weeks of supplementation, participants will return to the lab following an overnight fast to complete 300 maximal eccentric contractions of the knee extensors (20 sets of 15 with 30 seconds of rest between sets). Blood samples and measures of peak isometric, concentric and eccentric torque, muscle soreness and vertical jump performance will be taken before and immediately and 2, 24, 48, 72 and 168 hours after completion of the exercise. Participants will also collect all urine produced the day before, day of and day after the exercise. Partcipants will be asked to record all food intake using a food diary the day before, day of and day after exercise.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102278 0
Dr Troy Merry
Address 102278 0
University of Auckland
M&HS BUILDING 504 - Bldg 504
Level 2, Room 201
85 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country 102278 0
New Zealand
Phone 102278 0
+64 9 923 9008
Fax 102278 0
Email 102278 0
[email protected]
Contact person for public queries
Name 102279 0
Miss Sophie Broome
Address 102279 0
University of Auckland
M&HS BUILDING 504
Level 2, Room 234
University of Auckland
85 Park Road
Grafton
Auckland 1024
Country 102279 0
New Zealand
Phone 102279 0
+64 276061830
Fax 102279 0
Email 102279 0
[email protected]
Contact person for scientific queries
Name 102280 0
Miss Sophie Broome
Address 102280 0
University of Auckland
M&HS BUILDING 504
Level 2, Room 234
University of Auckland
85 Park Road
Grafton
Auckland 1024
Country 102280 0
New Zealand
Phone 102280 0
+64 276061830
Fax 102280 0
Email 102280 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.