Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001114336
Ethics application status
Approved
Date submitted
20/07/2017
Date registered
31/07/2017
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Profiling the acute post-exercise biochemical environment in trained athletes
Scientific title
The effect of resting and acute post-exercise biochemical milieus from divergent exercise stimuli and feeding in well-trained endurance and strength athletes on satellite cell cycling in vitro
Secondary ID [1] 292481 0
None
Universal Trial Number (UTN)
Trial acronym
ASS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle hypertrophy 304100 0
Condition category
Condition code
Musculoskeletal 303435 303435 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise and Sports Science Australia’s Adult Pre-exercise Screening Form: You will be required to complete this screening questionnaire to determine if you are ready to begin light/moderate intensity physical activity or if guidance from a health professional is required prior to commencing.

Consent Form: If you decide to participate in this study, a consent form will be signed prior to any study assessments being performed.

Cardiovascular Risk Factor Questionnaire: A cardiovascular risk factor questionnaire will be completed prior to any study assessments.

Body Composition:
A dual energy X-ray absorptiometry scan (DXA) is a specialised X-ray technique to provide a measure of body composition. Participants lay facing up on the scanning bed for the duration of the scan. This is just like a normal X-ray, with no pain involved and it will measure total body mass, fat mass and lean mass. The scan lasts for 7-8 minutes and participants will be scanned wearing light clothing one week prior to the exercise and nutrition intervention. A qualified technician will co-ordinate all DXA scans.

Strength and Power Testing
Maximum muscular strength of Group 1 will be determined during a series of one-repetition maximum (1RM) attempts. The 1RM attempts will be performed on the barbell back squat and deadlift. Following an appropriate warm-up for each selected exercise, a single repetition will then be performed with 5 minutes recovery periods between each attempt until the repetition load, that can be completed once but not a second time, is determined. The 1RM testing will only be performed by powerlifters, and will serve as the basis for prescribing exercise intensities. Mr. Shamim and Dr. Camera will co-ordinate all strength testing.

VO2Peak Test
The VO2max test is an incremental test to exhaustion on a stationary cycle ergometer. The workload increases every 2½ minutes until you can no longer maintain a pedaling rate of 60-70 rpm. This test is expected to last between 10-15 minutes. During the test, expired air is sampled as breaths are taken into a mouthpiece attached to an automated gas analyzer. The results from this test will provide a peak oxygen consumption reading, peak power output (PPO), and physiological data regarding cardiovascular health and fitness. The VO2max test will only be performed by cyclists and healthy age-matched individuals, and will serve as the basis for prescribing exercise intensities and representation of fitness, respectively. Mr. Shamim and Dr. Camera will co-ordinate all VO2max testing.

Dietary Standardisation
Prior to the trial day, all participants will consume a standardized meal provided by our research team based on personal preferences and presence of any known allergies. The diet will consist of 15-25% energy from protein, 45-65% energy from carbohydrate and 20-35% energy from fat. This distribution of macronutrient intake will ensure adequate energy to meet requirements outlined in the Australian Dietary Guidelines Acceptable Macronutrient Distribution Ranges (AMDR) for protein, carbohydrate and fat (expressed as a percentage contribution to total energy intake). In addition, a standardized breakfast will be served to all participants the morning of the trial. This meal will consist of similar macronutrient percentages as outlined above.

Blood Sampling
Two 50 mL samples of blood will be taken through venepuncture before, and after the exercise and nutrition intervention. This volume (total = 100 mL) is minimal compared to the standard 500 mL for a Red Cross donation. The 50 ml of blood collected on the two occasions is a volume equal to ~1% of total blood volume. Following the first blood draw, a standardized breakfast will be provided by the CEN before commencement of exercise to replenish fluid loses. In addition, light refreshments will also be provided by the CEN after the second blood sample to replenish the loss in blood volume.

Exercise Intervention
Participants in the Strength training (Group 1) and Endurance training (Group 2) will perform an acute bout of exercise, respective to their training discipline, while age-matched recreationally-trained participants (Group 3) will serve as a non-exercise control. Following a standardized breakfast, participants will rest for 90 minutes in a seated position. Subsequently, participants in Group 1 and 2 will complete their respective 90 minute exercise bout, followed by a 30 minute post-exercise rest before the final blood sample. Conversely, participants in Group 3 will continue to rest for 2 hours until the final blood sample.

All participants will undertake pre-testing and measures of body composition one week prior to the trial. All preliminary testing and exercise sessions will occur at the ACU gym under the supervision of Mr. Shamim and Dr. Camera. Both Mr. Shamim and Dr. Camera possess the appropriate Fitness Instruction qualification to safely teach through all the different exercise types. Participants will be allocated to one of the following three experimental groups based on training status:

Group 1: Strength Trained Athletes
Participants in Group 1 will consist of well-trained, drug-free, powerlifters who have achieved an Elite II three-lift total by the International Powerlifting Federation standards and have been training for a minimum of two years prior (>4 training sessions per week for previous 6 months). The acute exercise intervention will replicate a typical leg-training session for these athletes, and consist of the sets, repetitions, and intensities for movements outlined below. The duration of the exercise session, including adequate warm-ups, will be ~90 minutes.
• Acute Exercise Session:
1. Barbell back squat – 5 x 5 @ 75% 1RM
2. Deadlift – 3 x 3,2,1 @ 80, 85, 90% 1RM
3. Romanian Deadlift – 2 x 20 @ 50% 1RM

Group 2: Endurance Trained Athletes
Participants in Group 2 will consist of well-trained, drug-free, cyclists who have a VO2max > 65 mL/kg/min, competitively race at least A grade Victorian Road Series events, and have been training for a minimum of two years prior (>200 km/wk for previous 6 months). The acute exercise intervention will replicate a typical cycling session for these athletes, and consist of a combination of steady state cycling, interspersed with high-intensity sprint efforts performed on a stationary cycle ergometer, as described below. The duration of the exercise session, including adequate warm-up, will be ~90 minutes.
• Acute Exercise Session:
1. 90 minutes continuous cycling at 70% of VO2Peak
a. 60 second sprint efforts at 100% VO2Peak will occur every 10 minutes throughout the 90 minute protocol (i.e. 9 sprints)

Group 3: No Exercise Control
Participants in Group 3 will consist of participants with no previous history of performing exercise, but are otherwise healthy and age-matched to participants in either of the exercise groups. Participants in Group 3 will remain at rest for the length of the ~90 minute exercise bout performed by Groups 1 and 2.
Intervention code [1] 298660 0
Early detection / Screening
Comparator / control treatment
Control group is an age matched sedentary population who will remain resting for the duration of the trial.
Control group
Active

Outcomes
Primary outcome [1] 302818 0
The primary outcome of this study is to characterize the exerkine expression profile (i.e., myokines, miRNAs) present in serum of well-trained endurance and strength athletes and rest and after feeding and exercise, as well as in healthy untrained individuals at rest and after feeding.
Timepoint [1] 302818 0
At rest, immediately prior to breakfast (t = 0 min) and 30 minutes post exercise (t = 270 min)
Secondary outcome [1] 337144 0
Secondly, to determine whether transient changes to the acute post-exercise biochemical milieu improve satellite cell differentiation in vitro compared to resting serum from well trained endurance and strength-trained athletes. Additionally, to compare how the resting serum from well trained athletes effects in vitro satellite cell differentiation compared to healthy untrained individuals.
Timepoint [1] 337144 0
Analysis of secondary outcomes will be performed using blood samples taken immediately prior to breakfast (t = 0 min) and 30 minutes post-exercise (t = 270 min) in vitro models based in C2C12 cell lines. Accordingly, cells will be collected and analyzed after 48 and 72 h of differentiation in vitro.

Eligibility
Key inclusion criteria
a) male, b) aged 18-30 years and are either:
i) Untrained (exercising less than 60 minutes per week) and have a Body Mass Index (BMI) of 18.5-29
ii) A well-trained cyclist (VO2max > 65 mL/kg/min, competing in A grade Victorian Road Series events, training for a minimum of 2 years prior with > 200 km/wk in the last 6 months)
iii) A well trained powerlifter (International Powerlifting Federation Elite II Total, training for a minimum of 2 years prior with > 4 training sessions per week in the last 6 months)
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoking, vegan diets, anabolic steroid use.

Study design
Purpose of the study
Diagnosis
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)
Stratified allocation was employed in the study based on subject sport participation (or control)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A two-way with repeated measures analysis of variance for Time (Pre to Post intervention) and Treatment (Group 1 vs. Group 2 vs. Group 3) and Student-Newman-Keuls post hoc test will be used during data analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/12/2016
Date of last participant enrolment
Anticipated
31/08/2018
Actual
1/09/2018
Date of last data collection
Anticipated
30/09/2018
Actual
5/09/2018
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 16675 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 297051 0
University
Name [1] 297051 0
Australian Catholic University (ACU)
Country [1] 297051 0
Australia
Primary sponsor type
University
Name
ACU
Address
115 Victoria Parade, Fitzroy, VIC, 3065
Country
Australia
Secondary sponsor category [1] 296054 0
None
Name [1] 296054 0
Address [1] 296054 0
Country [1] 296054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298232 0
ACU Human Research Ethics Committee
Ethics committee address [1] 298232 0
Ethics committee country [1] 298232 0
Australia
Date submitted for ethics approval [1] 298232 0
16/09/2016
Approval date [1] 298232 0
23/11/2016
Ethics approval number [1] 298232 0
2016-216H

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

Contacts
Principal investigator
Name 76422 0
Dr Donny Camera
Address 76422 0
Dr. Donny Camera
The Mary MacKillop Institute for Health Research
215 Spring Street
Level 5
Melbourne, VIC, 3000
Country 76422 0
Australia
Phone 76422 0
+61 403166127
Fax 76422 0
Email 76422 0
[email protected]
Contact person for public queries
Name 76423 0
Baubak Shamim
Address 76423 0
Mr. Baubak Shamim
The Mary MacKillop Institute for Health Research
215 Spring Street
Level 5
Melbourne, VIC, 3000
Country 76423 0
Australia
Phone 76423 0
+61 432703424
Fax 76423 0
Email 76423 0
[email protected]
Contact person for scientific queries
Name 76424 0
Donny Camera
Address 76424 0
Dr. Donny Camera
The Mary MacKillop Institute for Health Research
215 Spring Street
Level 5
Melbourne, VIC, 3000
Country 76424 0
Australia
Phone 76424 0
+61 403166127
Fax 76424 0
Email 76424 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.