Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000577516
Ethics application status
Approved
Date submitted
10/04/2024
Date registered
7/05/2024
Date last updated
7/05/2024
Date data sharing statement initially provided
7/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can nutritional supplementation enhance molecular pathways responsible for building muscle following anterior cruciate ligament (ACL) injury?
Scientific title
Can nutritional supplementation enhance molecular pathways responsible for building muscle following anterior cruciate ligament
(ACL) injury?
Secondary ID [1] 311706 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ACL injury 333177 0
Condition category
Condition code
Musculoskeletal 329868 329868 0 0
Other muscular and skeletal disorders
Injuries and Accidents 330348 330348 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Magnetic Resonance Imaging (MRI) scans will be completed using a 3Tesla imaging system. Muscle volume of all lower limb muscles will be determined for both limbs using an automated segmentation platform at the beginning of the trial, prior to intervention. MRI Scans will be performed during each participant’s familiarisation visit, prior to nutrition and exercise interventions. Each participant will undergo a single MRI of both lower limbs that will take 30 minutes in total. Participants will be escorted to Swinburne Neuroimaging by research staff, with MRIs supervised by an experienced radiographer at Swinburne Neuroimaging (Swinburne University).
The evening prior to each experimental trial, participants will be provided a standardised meal to consume and be asked to arrive to the laboratory after an overnight fast (~8-10h). Participants will receive their standardised meal following their MRI at Swinburne University, comprised of chicken breast tenders/canned tuna/tofu, steam fresh carrot, cauliflower & broccoli, medium grain brown rice and butter.
Each participant will undergo unilateral leg-press 1 repetition maximum (1RM) testing once only, at their initial familiarisation visit, following their MRI. 1RM will be determined for both the injured and uninjured limb. A single 1RM test will be performed, supervised by trained research staff. Each limb will complete a warm up with load equivalent to 5 on a 10 rating of perceived exertion scale for 3-5 repetitions. Load will incrementally increase (by approx 5-20kg) and repetitions will decrease until the load an individual cannot successfully lift for 1 repetition is found. 1RM testing will take approximately 15 minutes to complete.
12 muscle biopsies in total will be obtained per participant; 1 pre exercise biopsy and 1 immediately post exercise from each leg. This will be repeated for each of the three supplement conditions (collagen peptides, whey protein, placebo).Additionally, 6 small blood samples (12mL each) will be collected, pre and post exercise for each of the three supplement conditions.
Supplementation: Immediately following resting muscle biopsy collection, participants will consume approximately 20g (female) or 30g (male) of whey protein isolate 20g (female) or 30g (male) of collagen peptides or an isocaloric placebo. Unflavoured, powdered supplements will be dissolved in orange juice. Participants will have 10 minutes to consume the supplement provided from an opaque cup.

Acute strength training intervention: Acute strength training will commence 20 minutes after participants finish consuming the supplement. Participants will complete a warm up of 10 reps on each leg with no load, before commencing the strength training intervention. In total, the intervention will run for 30 minutes, supervised by trained research staff. All participants will perform 6-8 sets of 8 repetitions of unilateral leg press exercise with load equivalent to 80% 1RM for each leg. Each set will be completed 1 leg at a time with limbs completing sets in alternating order. Each limb will be given 90sec rest between sets.
Shortly after the final muscle biopsy sampling and completion of experimental exercise session participants will be offered a light snack (e.g. muesli bar).
The washout period between each intervention will be no more than one week between experimental conditions.
Intervention code [1] 328176 0
Treatment: Other
Comparator / control treatment
Control group receive a placebo instead of a supplement. Placebo will be an unflavoured maltodextrin powder dissolved in juice. This will be compared against collagen peptides or whey protein.
Control group
Placebo

Outcomes
Primary outcome [1] 337648 0
Activation of key strength training signalling pathways. Measured pre- and post-strength training intervention.
Timepoint [1] 337648 0
Two time points will be measure:
1- 15 minutes prior to exercise and nutrition intervention
2- 30 minutes after completion of strength training intervention
Secondary outcome [1] 434562 0
Lower limb muscle morphology
Timepoint [1] 434562 0
Scan to be taken prior to intervention to allow comparison of morphology between injured and uninjured legs

Eligibility
Key inclusion criteria
Male or female

Aged between 18 to 40 years

One leg sustained an ACL injury within the last 5-years, but the participant can safely complete lower limb strength training.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ACL injury without surgical reconstruction

Any lower limb injury in the past 24-months that influences the quadriceps responses to exercise (e.g. muscle strain)

Known cardiovascular disease or diabetes

Known bleeding disorder (i.e. hemophilia A [factor VIII deficiency], hemophilia B [factor IX deficiency], von Willebrand disease, or other rare factor deficiencies including I, II, V, VII, X, XI, XII and XIII)

Major or chronic illness that impairs mobility or eating/digestion

Taking prescription medications (i.e. beta-blockers, anti-arrhythmic drugs, statins, insulin sensitising drugs, or drugs that increase the risk of bleeding [i.e. anticoagulants, antiplatelets, novel oral anticoagulants [NOAs], nonsteroidal anti-inflammatory drugs [NSAIDs], selective norepinephrine reuptake inhibitors [SNRI], or selective serotonin reuptake inhibitors [SSRIs])

Any contraindications to MRI assessed via the Swinburne Neuroimaging MRI Safety Questionnaire and Consent Form.

Individuals with allergy/intolerance to milk and/or milk products and/or seafood.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316036 0
University
Name [1] 316036 0
Australian Catholic University
Country [1] 316036 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Country
Australia
Secondary sponsor category [1] 318197 0
None
Name [1] 318197 0
Address [1] 318197 0
Country [1] 318197 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314857 0
ACU Human Research Ethics Committee
Ethics committee address [1] 314857 0
Ethics committee country [1] 314857 0
Australia
Date submitted for ethics approval [1] 314857 0
28/11/2023
Approval date [1] 314857 0
06/02/2024
Ethics approval number [1] 314857 0

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

Contacts
Principal investigator
Name 132950 0
Dr Nolan Hoffman
Address 132950 0
Australian Catholic University, 17 Young St, Fitzroy, Victoria, 3065
Country 132950 0
Australia
Phone 132950 0
+61 3 9230 8277
Fax 132950 0
Email 132950 0
[email protected]
Contact person for public queries
Name 132951 0
Nolan Hoffman
Address 132951 0
Australian Catholic University, 17 Young St, Fitzroy, Victoria, 3065
Country 132951 0
Australia
Phone 132951 0
+61 3 9230 8277
Fax 132951 0
Email 132951 0
[email protected]
Contact person for scientific queries
Name 132952 0
Nolan Hoffman
Address 132952 0
Australian Catholic University, 17 Young St, Fitzroy, Victoria, 3065
Country 132952 0
Australia
Phone 132952 0
+61 3 9230 8277
Fax 132952 0
Email 132952 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
No additional documents have been identified.