Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12622000529741
Ethics application status
Approved
Date submitted
24/03/2022
Date registered
4/04/2022
Date last updated
7/03/2023
Date data sharing statement initially provided
4/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of collagen hydrolysate on muscle recovery
Scientific title
Effect of collagen hydrolysate on recovery from downhill running in healthy men
Secondary ID [1] 306678 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise induced muscle damage 325858 0
Muscle recovery 325859 0
Condition category
Condition code
Musculoskeletal 322979 322979 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be given powder containing 25 g of protein from collagen hydrolysate, colouring and sweeteners or 25g of hydrolysed milk protein, colouring and sweeteners. The powder will be mixed with 250ml of water and consumed 45 minutes post-exercise and again 22, 46 and 70 hours post-exercise, along with a standardised meal. The approximate nutritional profile of the standardised meal is: 90g carbohydrate; 23g fat; 17g protein; 2904kJ.
The powder will be provided to participants in a plain vacuum sealed sachet which will be marked with either A, B or C - neither the researchers nor the participants will know which treatment they are consuming.
To ensure adherence to the intervention, participants will consume the first drink while at the laboratory and then be given the next days sachet at each subsequent visit to the laboratory. A text message will be sent each day to remind them to consume the powder, and meal.
Intervention code [1] 323127 0
Treatment: Other
Comparator / control treatment
Both collagen hydrolysate and milk protein powders will be compared to a placebo that will contain the equivalent weight to the other treatments, but will contain maltodextrin, sweeteners and colouring. The placebo powder will be mixed with 250ml of water and consumed 45 minutes post-exercise and again 22, 46 and 70 hours post-exercise, along with a standardised meal (as given in the other two treatment conditions).
The placebo will be presented in the same, plain vacuum sealed sachet as used for collagen hydrolysate (labelled A, B or C).
Control group
Placebo

Outcomes
Primary outcome [1] 330749 0
Delayed onset of muscle soreness - to assess exercise induced muscle soreness in the lower limbs, participants will rate localised soreness on a scale from 0 to 10 on a 100mm visual analogue scale, with 0 being no soreness and 10 being extreme soreness. This will be completed as the participants steps onto a box and when they lower into a squat position.
Timepoint [1] 330749 0
Muscle soreness will be measured 30 minutes prior to downhill running exercise and again 30 minutes and 24, 48 and 72 hours post-exercise.
Primary outcome [2] 330761 0
Muscle function
Lower body strength will be measured using a test called the midthigh pull. This involves standing on a small platform, knees and hips bent and a bar held in the hands. The bar is connected to a load cell and the platform by a chain; the load cell will measure how much force can be produced. Participants will be instructed to pull against the bar as forcefully as possible for 3 seconds; this will be repeated 3 times with a 30 second rest between each effort.
Timepoint [2] 330761 0
Muscle function will be measured 30 minutes prior to downhill running exercise and again 30 minutes and 24, 48 and 72 hours post-exercise.
Primary outcome [3] 330762 0
Running economy
The amount of oxygen used and effort required to run at a set speed (running economy) will be measured by running on a treadmill. A heart rate monitor will be fitted and participants will then undertake a 5 minute warmup at 60% VO2max speed. They will then complete 5 minutes running at 80% VO2max speed with a silicone face mask fitted over their mouth and nose so that expired gases can be measured.
Timepoint [3] 330762 0
Running economy will be measured 30 minutes prior to downhill running exercise and again 30 minutes and 24, 48 and 72 hours post-exercise.
Secondary outcome [1] 407427 0
Venous blood samples will be collected from a vein in either arm and the ratio of biomarkers of collagen synthesis (serum procollagen type I N-terminal peptide; P1NP) and degradation (plasma cross-linked C-terminal telopeptide of type I collagen; CTX-1) will be measured.
Timepoint [1] 407427 0
Blood biomarkers will be measured 30 minutes prior to downhill running exercise and again 30 minutes and 24, 48 and 72 hours post-exercise.
Secondary outcome [2] 408091 0
Blood biomarkers of inflammation (hsCRP and interleukin-6).
Timepoint [2] 408091 0
Blood biomarkers of inflammation will be measured 30 minutes prior to downhill running exercise and again 30 minutes and 24, 48 and 72 hours post-exercise.
Secondary outcome [3] 408092 0
Creatine kinase concentration in plasma (as a measure of muscle damage).
Timepoint [3] 408092 0
Creatine kinase will be measured 30 minutes prior to downhill running exercise and again 30 minutes and 24, 48 and 72 hours post-exercise.
Secondary outcome [4] 408093 0
To test the strength of the quadriceps (thigh) muscles of the right leg, participants will be seated on a machine called an isokinetic dynamometer. They will be strapped in place before completing 3 maximal effort leg extensions, each effort will be separated by 30 seconds rest.
Timepoint [4] 408093 0
Quadriceps strength will be measured 30 minutes prior to downhill running exercise and again 30 minutes and 24, 48 and 72 hours post-exercise.
Secondary outcome [5] 408094 0
Lower body power output will be measured using a vertical jump test. Jump height will be measured using a digital jump mat. Participants will stand on the mat, place their hands on their hips and, using a counter movement, jump as high as possible. They will make three attempts at this test, with a 30 second rest between jumps.
Timepoint [5] 408094 0
Lower body power output will be measured 30 minutes prior to downhill running exercise and again 30 minutes and 24, 48 and 72 hours post-exercise.

Eligibility
Key inclusion criteria
Healthy, active males
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
• If the individual undertakes regular (more than 3 times per week) strenuous exercise; this includes heavy resistance exercise or long duration/high intensity running.
• If the individual is dairy/lactose intolerant (the hydrolysed milk powder is dairy based)
• If the individual is vegetarian or vegan (as the supplements are made from animal products).
• If the individual consumes a high protein diet (more than 25% of their daily energy comes from protein) and/or regularly consumes protein supplements.
• If the individual regularly uses ergogenic supplements such as pre-workout products, branched chain amino acid (BCAA) powder, creatine monohydrate.
• If the individual has an injury or medical condition that could be made worse by exercising or stops them from participating in high intensity exercise
• If the individual has been ill in the 14 days before the study begins
• If the individual is participating in another research trial

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)
Sealed, coded, plain packaged sachets
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple, balanced randomisation using a randomisation table created by computer software to ensure participants are randomly allocated into each of the three groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study will recruit a maximum of 42 and a minimum of 36 participants. Sample size was calculated using G*Power software version 3.0.10. Using 80% power, moderate effect size and an alpha of 5% for repeated measures ANOVA, 9 participants are needed to determine differences in response between groups. However, to account for expected drop out and non-compliance, we will recruit a maximum of 42 participants.
Data will be analysed using mixed model ANOVA (group x time). If a main effect is found, post hoc analysis using Bonferroni adjustment will be carried out. Significance will be set at P<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/05/2022
Actual
26/09/2022
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
29/09/2023
Actual
Sample size
Target
42
Accrual to date
4
Final
Recruitment outside Australia
Country [1] 24669 0
New Zealand
State/province [1] 24669 0
Manawatu

Funding & Sponsors
Funding source category [1] 310869 0
Government body
Name [1] 310869 0
Ministry of Business Innovation and Employment
Country [1] 310869 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Private Bag 11-222
Palmerston North
4410
Country
New Zealand
Secondary sponsor category [1] 312131 0
Commercial sector/Industry
Name [1] 312131 0
Southern Pastures Investments
Address [1] 312131 0
Baker Tilly Staples Rodway Waikato L.P.
Level 4, BNZ Building
354 Victoria Street
Hamilton
3204
Country [1] 312131 0
New Zealand
Secondary sponsor category [2] 312364 0
Commercial sector/Industry
Name [2] 312364 0
Ovation Ltd
Address [2] 312364 0
PO Box 2646
1st Floor, 210 Maraekakaho Road
Hastings 4153
Country [2] 312364 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310431 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310431 0
Ethics committee country [1] 310431 0
New Zealand
Date submitted for ethics approval [1] 310431 0
11/04/2022
Approval date [1] 310431 0
12/05/2022
Ethics approval number [1] 310431 0
2022 EXP 12330

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

Contacts
Principal investigator
Name 117642 0
A/Prof Matthew Barnes
Address 117642 0
School of Sport, Exercise and Nutrition,
Crn Albany Drive and Collinson Rd,
Massey University,
Palmerston North,
4472
Country 117642 0
New Zealand
Phone 117642 0
+64 6 3569099
Fax 117642 0
Email 117642 0
[email protected]
Contact person for public queries
Name 117643 0
Matthew Barnes
Address 117643 0
School of Sport, Exercise and Nutrition,
Crn Albany Drive and Collinson Rd,
Massey University,
Palmerston North,
4472
Country 117643 0
New Zealand
Phone 117643 0
+64 6 3569099
Fax 117643 0
Email 117643 0
[email protected]
Contact person for scientific queries
Name 117644 0
Matthew Barnes
Address 117644 0
School of Sport, Exercise and Nutrition,
Crn Albany Drive and Collinson Rd,
Massey University,
Palmerston North,
4472
Country 117644 0
New Zealand
Phone 117644 0
+64 6 3569099
Fax 117644 0
Email 117644 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
For ethical reasons, no individualised data will be reported. Data will be presented as group mean and standard deviations.


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.