Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001154998
Ethics application status
Approved
Date submitted
17/09/2020
Date registered
3/11/2020
Date last updated
3/11/2020
Date data sharing statement initially provided
3/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Krill and Greenshell Mussel (GSM) on joint health and osteoarthritis
Scientific title
Effect of a combined Krill and Greenshell Mussel (GSM) supplement on joint health and osteoarthritis in an older adult population: A double-blind randomized placebo-controlled parallel study.
Secondary ID [1] 302336 0
Nil known
Universal Trial Number (UTN)
Trial acronym
WAI-GSM19
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Joint Health 319103 0
Osteoarthritis 319104 0
Condition category
Condition code
Musculoskeletal 317061 317061 0 0
Normal musculoskeletal and cartilage development and function
Musculoskeletal 317062 317062 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention for this study is Krill and Greenshell mussel oil (GSM). Participants will be instructed to take 1 capsule in the morning with food, for a total of 500 mg of krill/GSM oil per day for a total of 8 weeks. Each 500 mg capsule will contain 50 mg of GSM Oil and 450 mg of krill oil.

Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group or the active intervention group. Height, weight, waist and hip circumferences, blood pressure and questionnaires regarding joint pain, osteoarthritis symptoms, gastrointestinal tolerance and quality of life will be assessed at enrolment. Within the week pre-treatment, participant’s blood will be collected for analysis of pre-treatment inflammatory blood markers.

Prior to starting trial product, participants will complete 1 day of pain recording [(Vas) once morning and once at night] online. Following the completion of the pain recording, the participant will start taking the capsules. Participants will be asked to take the allocated product according to the dose prescribed (500 mg daily). In addition, participants will be asked to complete fortnightly questionnaires regarding their joint pain (Vas and WOMAC). Participants will undertake an additional blood test at week 4 and repeat all baseline measures at the completion of the trial (week 8).

At both time point visits (week 4 and 8) and as part of the assessment, participants will be asked to provide details regarding any lifestyle changes (diet, exercise, medication) in addition to subjective changes in exercise, performance and any adverse effects (including change mood/quality of life).

Participants will be monitored for compliance with the protocol by a combination of telephone and email communications in addition to each scheduled visit.
Intervention code [1] 318626 0
Treatment: Drugs
Comparator / control treatment
The placebo will be dosed in identical capsules to the Krill/GSM product and will contain glycerol.
Participants will be instructed to take 1 capsule in the morning with food identical to the Krill/GSM regime, for the duration of the interventional period (8 weeks).
Control group
Placebo

Outcomes
Primary outcome [1] 325158 0
Joint pain as measured by Visual Analog Scale
Timepoint [1] 325158 0
Baseline, Week 2, 4, 6 and 8
Secondary outcome [1] 387030 0
Osteoarthritis Symptoms as measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC scale)
Timepoint [1] 387030 0
Baseline, Week 2, 4, 6 and 8
Secondary outcome [2] 387031 0
Any change in rescue medication use as reported by participants during in clinic visits
Timepoint [2] 387031 0
Baseline, Week 4 and Week 8
Secondary outcome [3] 387032 0
Anthropometry - Height measured using a stadiometer
Timepoint [3] 387032 0
Baseline, Week 4 and Week 8
Secondary outcome [4] 387033 0
Quality of life as measured by SF-36 questionnaire
Timepoint [4] 387033 0
Baseline, Week 4 and Week 8
Secondary outcome [5] 387034 0
TNF-a inflammatory markers as measured by blood test
Timepoint [5] 387034 0
Baseline, Week 4 and Week 8
Secondary outcome [6] 387035 0
IL-6 inflammatory markers as measured by blood test
Timepoint [6] 387035 0
Baseline, Week 4 and Week 8
Secondary outcome [7] 387036 0
IL-8 Inflammatory markers as measured by blood test
Timepoint [7] 387036 0
Baseline, Week 4 and Week 8
Secondary outcome [8] 387037 0
IL-10 Inflammatory markers as measured by blood test
Timepoint [8] 387037 0
Baseline, Week 4 and Week 8
Secondary outcome [9] 387038 0
hs-CRP Inflammatory markers as measured by blood test
Timepoint [9] 387038 0
Baseline, Week 4 and Week 8
Secondary outcome [10] 387039 0
AST safety markers as measured by blood test
Timepoint [10] 387039 0
Baseline, Week 4 and Week 8
Secondary outcome [11] 387040 0
ALT safety markers as measured by blood test
Timepoint [11] 387040 0
Baseline, Week 4 and Week 8
Secondary outcome [12] 387041 0
GGT safety markers as measured by blood test
Timepoint [12] 387041 0
Baseline, Week 4 and Week 8
Secondary outcome [13] 387042 0
Bilirubin safety markers as measured by blood test
Timepoint [13] 387042 0
Baseline, Week 4 and Week 8
Secondary outcome [14] 387043 0
Albumin safety markers as measured by blood test
Timepoint [14] 387043 0
Baseline, Week 4 and Week 8
Secondary outcome [15] 388036 0
Anthropometry - Weight as measured by digital scales
Timepoint [15] 388036 0
Baseline, Week 4 and Week 8
Secondary outcome [16] 388037 0
Anthropometry - waist circumference as measured with measuring tape
Timepoint [16] 388037 0
Baseline, Week 4 and Week 8
Secondary outcome [17] 388038 0
Anthropometry - hip circumference as measured by measuring tape
Timepoint [17] 388038 0
Baseline, Week 4 and Week 8
Secondary outcome [18] 388043 0
Anthropometry - BMI calculated using measurements from height and weight (measured using stadiometer and digital scales)
Timepoint [18] 388043 0
Baseline, Week 4 and Week 8
Secondary outcome [19] 388044 0
Quality of life (Depression, anxiety and stress) as measured by DASS questionnaire
Timepoint [19] 388044 0
Baseline, Week 4 and Week 8

Eligibility
Key inclusion criteria
• Males and females aged over 45 years old inclusive
• Diagnosed with osteoarthritis
• Reporting joint pain (not associated with acute injury, long-standing disease or prescription medication use)
• Otherwise healthy, BMI 18.5-34.9 kg/m2
• Able to provide informed consent
• Agree not to change current diet and exercise program
• Access to internet
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland function malignancy)*
• Malignancy (current) or treatment (chemotherapy and radiotherapy) for malignancy within the previous 2 years
• Clinically significant acute or chronic inflammation, or connective tissue disease including, but not limited to rheumatoid arthritis, bursitis or gout.
• Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy
• Receiving treatment or taking supplements for joint pain/health such as glucosamine and omega-3 containing products#.
• Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse
• Chronic past and/or current alcohol use (>14 alcoholic drinks week)
• Allergic to seafood or any of the ingredients in the active or placebo formula
• Known pregnant or lactating woman
• Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
• Participants who have participated in any other related clinical study during the past 1 month
• History of infection in the month prior to the study

*An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

#Potential participants that are taking supplements that would result in their exclusion must wait a 4-week washout period prior to commencing the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Phase 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/11/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 306765 0
Commercial sector/Industry
Name [1] 306765 0
Waitaki Biosciences
Country [1] 306765 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
RDC Global Pty Ltd
3B/76 Doggett Street, Newstead, QLD 4006
Country
Australia
Secondary sponsor category [1] 307317 0
Commercial sector/Industry
Name [1] 307317 0
Waitaki Biosciences
Address [1] 307317 0
3 Desi Place
Hillsborough 8022, Christchurch, NZ
Country [1] 307317 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306930 0
University of Queensland Human Research Ethic Committee A
Ethics committee address [1] 306930 0
Ethics committee country [1] 306930 0
Australia
Date submitted for ethics approval [1] 306930 0
Approval date [1] 306930 0
09/04/2020
Ethics approval number [1] 306930 0

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

Contacts
Principal investigator
Name 105486 0
Dr David Briskey
Address 105486 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 105486 0
Australia
Phone 105486 0
+61 421 784 077
Fax 105486 0
Email 105486 0
[email protected]
Contact person for public queries
Name 105487 0
Amanda Rao
Address 105487 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 105487 0
Australia
Phone 105487 0
+61 414 488 559
Fax 105487 0
Email 105487 0
[email protected]
Contact person for scientific queries
Name 105488 0
Amanda Rao
Address 105488 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 105488 0
Australia
Phone 105488 0
+61 414 488 559
Fax 105488 0
Email 105488 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
No IPD will be shared


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.