Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000974606p
Ethics application status
Not yet submitted
Date submitted
18/08/2023
Date registered
7/09/2023
Date last updated
7/09/2023
Date data sharing statement initially provided
7/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Can 8 weeks of supplementation with 4g/day of Krill oil reduce pain and enhance recovery from muscle damaging exercise in young, untrained, healthy men and women? Krill oil supplementation as an exercise recovery aid.
Scientific title
Can 8 weeks of supplementation with 4g/day of Krill oil reduce pain and enhance recovery from muscle damaging exercise in young, untrained, healthy men and women? Krill oil supplementation as an exercise recovery aid.
Secondary ID [1] 310353 0
NIL
Universal Trial Number (UTN)
U1111-1295-8753
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle pain 331121 0
Muscle function 331327 0
Muscle swelling 331328 0
Muscle damage 331329 0
Condition category
Condition code
Diet and Nutrition 327902 327902 0 0
Other diet and nutrition disorders
Musculoskeletal 327903 327903 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group will consume SUPERBA Krill Oil oral capsule 4g once daily for 8 weeks. Each capsule contains 1g of Krill oil, therefore each participant will consume 4 capsules orally.
Adherence to intervention will be monitored by counting the capsules at post-
supplementation testing.
Intervention code [1] 326782 0
Treatment: Other
Comparator / control treatment
Control group will consume 4g/day of SUPERBA placebo for 8 weeks. Each participant will consume 4 capsules once daily orally. Placebo contains mixture of olive oil, corn oil, palm oil and medium chain triglycerides in the ratio of 4:4:3:2.
Control group
Placebo

Outcomes
Primary outcome [1] 335753 0
Muscle pain assessed using a visual analogue scale.
Timepoint [1] 335753 0
Post-supplementation (8 weeks after supplementation)
Primary outcome [2] 335756 0
Blood analyses for circulating markers of muscle damage (circulating creatine kinase (CK), Lactate dehydrogenase (LDH)) using enzyme-linked immunoassay (ELISA) kit.
Timepoint [2] 335756 0
Post-supplementation (8 weeks after supplementation).
Primary outcome [3] 335949 0
Muscle Swelling assessed using ultrasound scans
Timepoint [3] 335949 0
Post-supplementation (8 weeks after supplementation)
Secondary outcome [1] 425475 0
Anthropometry: We will assess whole body composition estimates using DEXA scan.
Timepoint [1] 425475 0
Baseline pre-supplementation, post-supplementation (8 weeks after supplementation).
Secondary outcome [2] 425477 0
Sleep (Pittsburgh Sleep Quality Index Questionnaire). To monitor sleep habits.
Timepoint [2] 425477 0
Baseline pre-supplementation, post-supplementation (8 weeks after supplementation)
Secondary outcome [3] 425484 0
Menstrual pain (menstrual diary). to track menstrual cycle
Timepoint [3] 425484 0
Baseline pre-supplementation, post-supplementation (8 weeks after supplementation)
Secondary outcome [4] 426244 0
This is a primary outcome.
Muscle Function assessed using isokinetic dynamometer
Timepoint [4] 426244 0
Post-supplementation (8 weeks after supplementation)

Eligibility
Key inclusion criteria
1-Aged 18-35 years, Males & females,
2-Healthy non-resistance trained (no structured resistance training in past 6 months),
3-Sedentary lifestyle,
4-Weight stable (no more than +/-2 kgs of weight change in last 2 months) adults.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1- Aged <18 or > 35 years
2- Self-report as having had a musculoskeletal injury in the past 6 months,
3- Participation in structured resistance training in the past 6 months,
4- Allergies to any of the contents of fish oil or shellfish,
5- BMI <18.5 or BMI >27,
6- Currently participating in a weight loss program or special diet (e.g., Low carbohydrate, ketogenic, vegan etc),
7- Current smokers,
8- Acute or terminal illness,
9- Functional impairment that would limit inclusion in the trial,
10- Use of sports supplements or pain medication in the last month,
11- Current chronic disease including cancer, diabetes, cardiovascular disease, chronic liver disease, and gastrointestinal disorders that affects nutrient absorption,
12- Cognitive impairment or inability to commit to the study and its requirements or be randomised to their experimental group.
13- Known or family history of Bleeding disorders (haemophilia).
14- Connective tissue disorders (hypermobility, Ehlers Dalons syndrome etc)

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)
Randomisation will be at the level of the individual participant (ID) using a computer-generated random number sequence by an independent researcher not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will then be asked to come into Deakin university for the first visit (pre- supplementation) where we will conduct assessments of body composition, Omega-3 index testing and sleep monitoring. Some of these measurements will be used to pair-match participants prior to randomisation into experimental groups. Participants will be pair-matched based on sex, and baseline lean mass before being randomised into placebo or treatment groups. Randomisation will be computer-generated (random number sequence) by an independent researcher.
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
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In studies where moderate pain is induced by exercise induced muscle damage (EIMD) the placebo group tends to rate pain at a level of 57.4mm with a standard deviation of 17.7mm. The minimal clinically important difference for the VAS pain scale is 14mm. Therefore, to detect a minimal clinically important difference of 14mm with an alpha of 0.05 and a power of 80% we will need 25 participants per treatment arm. To allow for study dropouts and to ensure equal matching between males and females we will recruit 30 participants per treatment arm for a final participant number of 60. Appropriate statistical testing will be utilised for each set of outcome measures. For instance, for assessing pre to post intervention changes in body composition, percentage change scores will be calculated for each participant and between-group comparisons will be made using t-tests if the data meets parametric assumptions, with the Mann-Whitney U test as the non-parametric alternative. For other outcomes, linear regression models will be used to compare groups on the post-treatment outcome while adjusting for baseline levels (ANCOVA approach). Within-group changes in outcomes will also be assessed using the appropriate statistical methods, for example paired t-tests. All tests will be two-tailed with statistical significance set at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/01/2024
Actual
Date of last participant enrolment
Anticipated
8/01/2025
Actual
Date of last data collection
Anticipated
10/04/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314558 0
University
Name [1] 314558 0
Deakin University
Country [1] 314558 0
Australia
Funding source category [2] 314589 0
Commercial sector/Industry
Name [2] 314589 0
Aker Biomarine
Country [2] 314589 0
Norway
Primary sponsor type
University
Name
Deakin University
Address
Institue of Exercise and Nutrition Sciences
Deakin University
75 Pigdons Rd
Waurn Ponds
Victoria 3216
Country
Australia
Secondary sponsor category [1] 316516 0
None
Name [1] 316516 0
Address [1] 316516 0
Country [1] 316516 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313595 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 313595 0
Ethics committee country [1] 313595 0
Australia
Date submitted for ethics approval [1] 313595 0
20/09/2023
Approval date [1] 313595 0
Ethics approval number [1] 313595 0

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

Contacts
Principal investigator
Name 128686 0
Dr David Lee Hamilton
Address 128686 0
Deakin University Waurn Ponds Campus, 75 Pigdons, Waurn Ponds, VIC 3216
Country 128686 0
Australia
Phone 128686 0
+61 3 92445207
Fax 128686 0
Email 128686 0
[email protected]
Contact person for public queries
Name 128687 0
David Lee Hamilton
Address 128687 0
Deakin University Waurn Ponds Campus, 75 Pigdons, Waurn Ponds, VIC 3216
Country 128687 0
Australia
Phone 128687 0
+61 3 92445207
Fax 128687 0
Email 128687 0
[email protected]
Contact person for scientific queries
Name 128688 0
David Lee Hamilton
Address 128688 0
Deakin University Waurn Ponds Campus, 75 Pigdons, Waurn Ponds, VIC 3216
Country 128688 0
Australia
Phone 128688 0
+61 3 92445207
Fax 128688 0
Email 128688 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices).
When will data be available (start and end dates)?
Immediately following publication to 5 years following publication.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve aims in the approved proposal.
How or where can data be obtained?
proposals should be directed to [email protected]. To gain access, data requesters will need to sign a data access agreement.


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.