Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
[email protected]
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
[email protected]
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
[email protected]

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.