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Trial registered on ANZCTR


Registration number
ACTRN12616001345471
Ethics application status
Approved
Date submitted
8/08/2016
Date registered
27/09/2016
Date last updated
7/08/2020
Date data sharing statement initially provided
7/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Mitochondrial peptides and exercise
Scientific title
The effect of high intensity acute exercise and exercise training on mitochondrial derived peptide levels in healthy adult males
Secondary ID [1] 289894 0
None
Universal Trial Number (UTN)
U1111-1185-6033
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolism 299852 0
Condition category
Condition code
Metabolic and Endocrine 300070 300070 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend the laboratory 11 times over 4 weeks. The first visit will be screening and involve a DEXA scan, isometric strength test an incremental exercise test (VO2max test; 10-15 min of stationary cycle exercise) during which respiratory gas will be sampled and heart rate will be monitored. In the second and last (11th) visit participants will undertake a 500 kj (~30-45 min of exercise) performance trial on a stationary exercise bike to assess performance. The remaining visits will involve 8-12 repeated 60 s intervals of high-intensity stationary cycling (100% peak power output determined from VO2max test) with 75 s of recovery between each repetition. The number of repeats will start at 8 and be increased dependent on improvements over each session. Each session will be ~30 min and the number of repetitions will increase over the coarse of the two weeks. There will at least 1 day rest between each exercise session. On the 3rd and 10th (second to last) visit we will collect muscle, blood and urine samples before, immediately following and 3 h post exercise. A cannula and/or venepuncher will be used for sampling blood, and a bergstrom biopsy needle for collecting samples from the thigh muscle under local anaesthetic. The interventions will be delivered by trained exercise physiologists.
Intervention code [1] 295573 0
Treatment: Other
Comparator / control treatment
Internal control, pre-post intervention
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299221 0
Plasma mitochondrial derived peptide levels will be assessed via ELISA.
Timepoint [1] 299221 0
Before, immediately following and 3h post exercise on visits 3 and 10.
Primary outcome [2] 299541 0
Muscle mitochondrial peptide levels will be measured in biopsy samples via western blot.
Timepoint [2] 299541 0
Before, immediately following and 3h post exercise on visits 3 and 10.
Secondary outcome [1] 326548 0
Exercise performance as assessed by cycle work trial.

Timepoint [1] 326548 0
Vist 2 and 11.
Secondary outcome [2] 327474 0
Mitochondrial biogenesis assessed via enzyme assays and western blood of muscle biopsy samples
Timepoint [2] 327474 0
Pre-exercise muscle sample collected at on visit 3 and 10. Secondary outcome will only be measured in these samples.

Eligibility
Key inclusion criteria
- Male
- 18-35 years
- Sedentary to moderately active (structured activity of less than 4 hours per week)
- Healthy
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any chronic or advance health conditions or injuries
- History of alcohol abuse
- Smoking
- Taking medications which may affect exercise responses

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pre-post intervention
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANOVA or non-parametric tests where appropriate and followed up with post-hoc tests will be used to determine differences in end points. Significance will be accepted at P<0.05.

Sample size calculation is based on the primary endpoint being mitochondrial derived peptide levels and previous experience. A total of 9-10 participants will be needed to detect a 25% increase at a power of 80% and alpha value of 0.05, if we expect a mean blood level of mitochondrial derived peptide of 150 pg/ml +/- 30.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2016
Actual
1/02/2017
Date of last participant enrolment
Anticipated
Actual
19/06/2017
Date of last data collection
Anticipated
Actual
14/07/2017
Sample size
Target
10
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 8086 0
New Zealand
State/province [1] 8086 0
Auckland

Funding & Sponsors
Funding source category [1] 294260 0
University
Name [1] 294260 0
The University of Auckland
Country [1] 294260 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
85 Park Rd
Grafton
Auckland, 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 293095 0
None
Name [1] 293095 0
Address [1] 293095 0
Country [1] 293095 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295688 0
Health and Disability Ethics Committee
Ethics committee address [1] 295688 0
Ethics committee country [1] 295688 0
New Zealand
Date submitted for ethics approval [1] 295688 0
04/08/2016
Approval date [1] 295688 0
02/09/2016
Ethics approval number [1] 295688 0
16/STH/116

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

Contacts
Principal investigator
Name 68134 0
Dr Troy Merry
Address 68134 0
Dept, Molecular Medicine and Pathology
Faculty of Medical Sciences
The University of Auckland
Private Bag 92019
Auckland, 1142
New Zealand
Country 68134 0
New Zealand
Phone 68134 0
+64 9 923 9008
Fax 68134 0
Email 68134 0
t.merry@auckland.ac.nz
Contact person for public queries
Name 68135 0
Troy Merry
Address 68135 0
Dept, Molecular Medicine and Pathology
Faculty of Medical Sciences
The University of Auckland
Private Bag 92019
Auckland, 1142
New Zealand
Country 68135 0
New Zealand
Phone 68135 0
+64 9 923 9008
Fax 68135 0
Email 68135 0
t.merry@auckland.ac.nz
Contact person for scientific queries
Name 68136 0
Troy Merry
Address 68136 0
Dept, Molecular Medicine and Pathology
Faculty of Medical Sciences
The University of Auckland
Private Bag 92019
Auckland, 1142
New Zealand
Country 68136 0
New Zealand
Phone 68136 0
+64 9 923 9008
Fax 68136 0
Email 68136 0
t.merry@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
No additional documents have been identified.