Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000451101
Ethics application status
Approved
Date submitted
15/03/2019
Date registered
19/03/2019
Date last updated
24/04/2020
Date data sharing statement initially provided
19/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of MitoQ supplementation on cycling performance in trained individuals
Scientific title
The effect of MitoQ supplementation on cycling performance in trained individuals
Secondary ID [1] 297725 0
Nil known
Universal Trial Number (UTN)
U111112104703
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise-induced oxidative stress 312052 0
Condition category
Condition code
Physical Medicine / Rehabilitation 310616 310616 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is a cross-over trial. Participants will be randomised into two groups, which will determine the order in which they receive MitoQ (20 mg/d mitoquinone) and a placebo. Participants will consume one tablet per day containing MitoQ or a placebo for 4 weeks before completing an exercise performance test. There will be a 6 week washout period between treatments. After this washout period, participants will cross over into the other treatment group and supplement for 4 weeks before repeating the exercise performance test.

Adherence to the intervention will be assessed by oversupplying the participants with MitoQ and placebo tablets and counting the number of tablets returned at the end of the study.
Intervention code [1] 313967 0
Prevention
Comparator / control treatment
Identical placebo tablet containing tapioca powder, precipitated silica and microcrystalline cellulose 101
Control group
Placebo

Outcomes
Primary outcome [1] 319467 0
Time to complete an 8 km cycling time trial on a stationary cycle ergometer
Timepoint [1] 319467 0
After an initial loading period, during which participants will cycle on a stationary cycle ergometer for 45 minutes at 70% of their peak power output, time to complete an 8 km cycling time trial will be recorded following 4 weeks of supplementation with MitoQ and 4 weeks of placebo treatment.
Secondary outcome [1] 368279 0
Markers of exercise-induced oxidative stress including GSH/GSSG ratio and F2-isoprostanes will be measured in whole blood and plasma using biochemical assays. This is a composite secondary outcome.
Timepoint [1] 368279 0
Markers of oxidative stress including GSH/GSSG ratio and F2-isoprotanes will be measured in plasma and whole blood immediately before exercise, immediately after completion of the 45 minute loading period at 70% of the participant's peak power output, and immediately after the completion of an 8 km time trial following 4 weeks of supplementation with MitoQ and 4 weeks placebo treatment.

Eligibility
Key inclusion criteria
Male
35-50 years
Cycle trained (at least 4 hours of cycling per week on average over the last 6 months)
Healthy
Minimum age
35 Years
Maximum age
50 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

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 analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Due to the global pandemic caused by Covid-19, recruitment of this study has been stopped early as New Zealand has gone into level 4 lockdown
Date of first participant enrolment
Anticipated
15/04/2019
Actual
30/04/2019
Date of last participant enrolment
Anticipated
Actual
13/06/2019
Date of last data collection
Anticipated
Actual
12/12/2019
Sample size
Target
25
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 21347 0
New Zealand
State/province [1] 21347 0
Auckland

Funding & Sponsors
Funding source category [1] 302254 0
Commercial sector/Industry
Name [1] 302254 0
Callaghan Innovation
Country [1] 302254 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] 302115 0
None
Name [1] 302115 0
Address [1] 302115 0
Country [1] 302115 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302930 0
Health & Disability Ethics Committee
Ethics committee address [1] 302930 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 302930 0
New Zealand
Date submitted for ethics approval [1] 302930 0
15/01/2019
Approval date [1] 302930 0
12/02/2019
Ethics approval number [1] 302930 0
18/CEN/136/AM01

Summary
Brief summary
This study will be a randomised, double blind, crossover design, placebo-controlled trial. The intervention will involve the consumption of MitoQ. Testing will take place at the University of Auckland Grafton Campus. 25 healthy, trained male cyclists aged 35-50 years will be recruited to take part in the study.

Participants will be asked to visit the University of Auckland Grafton Campus on 5 occasions over a period of 15 weeks to perform exercise on a stationary cycle ergometer. 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 that will obtain a history of exercise and health to determine their eligibility to participate in the study. Participants will undergo a maximal aerobic capacity test (VO2max) on a cycle ergometer.

During visit 2 and 3 the participant will undergo a familiarisation to the exercise performance test. The exercise performance test will require the participants to cycle for 45 minutes at a fixed intensity of 70% of their peak work output (from VO2max test). Immediately after this initial loading period, participants will perform a 200 kJ workload time trial, during which they will complete 200 kJ of work on the bike, as fast as possible and at an intensity that they can determine themselves. This is equivalent to cycling 8km and is expected to take another 10-15 minutes.

Participants will be randomly assigned to one of two groups, which will determine the order in which they receive MitoQ and the placebo. Participants will receive a tablet containing either MitoQ (20mg mitoquinol), or a placebo (tapioca powder, precipitated silica and microcrystalline cellulose 101) daily for 4 weeks before visit 4 and 5. Written instructions for consumption will be provided.

Participants will be asked to complete a 3 day food diary prior to visits 4 and 5. Participants will be provided with a standard evening and breakfast meal for consumption on the evening and morning before visits 4 and 5. These meals will provide 25-30% of their daily caloric intake (60% of the calories as carbohydrates, 20% as protein and 20% as lipids).
A cannula will be inserted into the participant’s antecubital fossa by a researcher who is trained in phlebotomy. Participants will then complete the exercise performance test and blood samples will be taken before exercise, after completion of the 45 minute loading period, and after exercise. There will be a 6 week washout period after visit 4. Participants will then cross over into the other treatment group before completing visit 5.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91882 0
Dr Andrea Braakhuis
Address 91882 0
M&HS BUILDING 504
Level 2, Room 221
The University of Auckland
85 PARK RD
GRAFTON
AUCKLAND 1023
Country 91882 0
New Zealand
Phone 91882 0
+64 9 923 6251
Fax 91882 0
Email 91882 0
[email protected]
Contact person for public queries
Name 91883 0
Sophie Broome
Address 91883 0
M&HS BUILDING 504
Level 2, Room 234
University of Auckland
85 Park Road
Grafton
Auckland 1024
Country 91883 0
New Zealand
Phone 91883 0
+64 276061830
Fax 91883 0
Email 91883 0
[email protected]
Contact person for scientific queries
Name 91884 0
Sophie Broome
Address 91884 0
M&HS BUILDING 504
Level 2, Room 234
University of Auckland
85 Park Road
Grafton
Auckland 1024
Country 91884 0
New Zealand
Phone 91884 0
+64 276061830
Fax 91884 0
Email 91884 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
SourceTitleYear of PublicationDOI
Dimensions AIMitochondria-targeted antioxidant supplementation improves 8 km time trial performance in middle-aged trained male cyclists2021https://doi.org/10.1186/s12970-021-00454-0
N.B. These documents automatically identified may not have been verified by the study sponsor.