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Trial registered on ANZCTR


Registration number
ACTRN12612000467831
Ethics application status
Approved
Date submitted
16/04/2012
Date registered
27/04/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Protease supplementation and delayed onset muscle soreness (DOMS)
Scientific title
A randomised placebo controlled crossover trial to compare the effects of consumption of a protease supplement on delayed muscle soreness in healthy males.
Secondary ID [1] 280329 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
exercise-induced delayed onset muscle soreness. 286292 0
Condition category
Condition code
Diet and Nutrition 286527 286527 0 0
Other diet and nutrition disorders
Musculoskeletal 286627 286627 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised, placebo-controlled, crossover study with two arms.
Arm 1: Whey protein drink (500mL) with a protease enzyme (43mg).
Arm 2: Whey protein drink (500mL) without the protease enzyme.
This study will be carried out to assess the effects of consuming a whey protein drink with and without a protease on delayed onset muscle soreness (DOMS), physical performance, inflammation, and amino acid availability. Participants will be assigned in random order to receive the 2 treatments. There will be a 4-week washout between treatments. The beverages will be consumed for 4 days before exercise and 4 days following exercise. On the exercise day the beverage will be consumed immediately following exercise. For the exercise component each participant will complete a 30 min downhill run on a treadmill with a -10% grade at 70% their maximal heartrate.
Intervention code [1] 284687 0
Prevention
Comparator / control treatment
Placebo: Will receive the whey protein beverage without the protease.
Control group
Placebo

Outcomes
Primary outcome [1] 286958 0
Primary Outcome 1: Perceived muscle soreness using a Visual Analogue Scale (VAS) and an algometer.
Timepoint [1] 286958 0
Timepoint: at baseline, and 3, 24, 48, 72 and 96 hours post-exercise
Primary outcome [2] 286959 0
Primary Outcome 2: Muscle strength using a Biosex Isokinetic Dynanometer.
Timepoint [2] 286959 0
Timepoint: at baseline and 3 days post-exercise
Primary outcome [3] 286960 0
Primary Outcome 3: Inflammation
Plasma assay for CRP
Timepoint [3] 286960 0
Timepoint: at baseline, and 24, 48 and 72 hours post-exercise
Secondary outcome [1] 297058 0
Secondary Outcome 1: blood amino acid concentration
Timepoint [1] 297058 0
Timepoint: at baseline, and 15, 30, 45, 60, 75, 90 and 120 minutes post-ingestion of whey protein with and without the protease.

Eligibility
Key inclusion criteria
Healthy, physically active males aged between 18 and 40 years.
Minimum age
18 Years
Maximum age
40 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with chronic disease
People who are unable to run continuously for 45 minutes
People with dairy allergies
People with lactose intolerance
People with dairy intolerance

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be used. This will be achieved through allocation being performed by a research assistant who will have no involvement in the enrolment process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be performed using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4261 0
New Zealand
State/province [1] 4261 0
Otago

Funding & Sponsors
Funding source category [1] 285105 0
Commercial sector/Industry
Name [1] 285105 0
Roxlor Global
Address [1] 285105 0
1013 Centre Rd Suite
106 Wilmington,
DE 19805
USA
Country [1] 285105 0
United States of America
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
PO Box 56
Dunedin, 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 283963 0
None
Name [1] 283963 0
Address [1] 283963 0
Country [1] 283963 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287117 0
University of Otago Human Ethics Committtee
Ethics committee address [1] 287117 0
Human Ethics Committtee
University of Otago
PO Box 56
Dunedin 9054
Ethics committee country [1] 287117 0
New Zealand
Date submitted for ethics approval [1] 287117 0
Approval date [1] 287117 0
13/04/2012
Ethics approval number [1] 287117 0
1/12/0047

Summary
Brief summary
Eccentric exercise such as down hill running can cause muscle damage and soreness, which typically peaks after 2-4 days. This is referred to as delayed onset muscle soreness (DOMS). Supplementation with proteases (a group of biologically active enzymes) may reduce this damage, possibly by reducing inflammation. This project will compare the effects of a protease supplement versus a placebo on delayed muscle soreness, physical performance and inflammation following a bout of eccentric exercise. A secondary aim of this project is to assess the uptake of amino acids from a whey protein supplement with and without (placebo) the addition of a protease.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 34068 0
A/Prof Rachel Brown
Address 34068 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9056
Country 34068 0
New Zealand
Phone 34068 0
+64 3 479 5839
Fax 34068 0
Email 34068 0
rachel.brown@otago.ac.nz
Contact person for public queries
Name 17315 0
A/Prof Rachel Brown
Address 17315 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin, 9054
Country 17315 0
New Zealand
Phone 17315 0
+64 3 479 5839
Fax 17315 0
Email 17315 0
rachel.brown@otago.ac.nz
Contact person for scientific queries
Name 8243 0
A/Prof Rachel Brown
Address 8243 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin, 9054
Country 8243 0
New Zealand
Phone 8243 0
+64 3 479 5839
Fax 8243 0
Email 8243 0
rachel.brown@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary