ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

Prevention

Comparator / control treatment

Identical placebo tablet containing tapioca powder, precipitated silica and microcrystalline cellulose 101

Control group

Placebo

Outcomes

Primary outcome [1]

Time to complete an 8 km cycling time trial on a stationary cycle ergometer

Timepoint [1]

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]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Callaghan Innovation

Address [1]

Level 4
139 Quay Street
Auckland 1010

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health & Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

15/01/2019

Approval date [1]

12/02/2019

Ethics approval number [1]

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

Dr Andrea Braakhuis

Address

M&HS BUILDING 504
Level 2, Room 221
The University of Auckland
85 PARK RD
GRAFTON
AUCKLAND 1023

Country

New Zealand

Phone

+64 9 923 6251

Fax

a.braakhuis@auckland.ac.nz

Contact person for public queries

Name

Sophie Broome

Address

M&HS BUILDING 504
Level 2, Room 234
University of Auckland
85 Park Road
Grafton
Auckland 1024

Country

New Zealand

Phone

+64 276061830

Fax

s.broome@auckland.ac.nz

Contact person for scientific queries

Name

Sophie Broome

Address

M&HS BUILDING 504
Level 2, Room 234
University of Auckland
85 Park Road
Grafton
Auckland 1024

Country

New Zealand

Phone

+64 276061830

Fax

s.broome@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Dimensions AI	Mitochondria-targeted antioxidant supplementation improves 8 km time trial performance in middle-aged trained male cyclists	2021	https://doi.org/10.1186/s12970-021-00454-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically