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Trial registered on ANZCTR


Registration number
ACTRN12618001853235p
Ethics application status
Not yet submitted
Date submitted
9/11/2018
Date registered
14/11/2018
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Green Shell Mussel Powder on pain and analgesic medication use in people with joint pain:
a pilot study
Scientific title
The effect of Green Shell Mussel Powder on pain and analgesic medication use in people with joint pain:
a pilot study
Secondary ID [1] 296560 0
Nil.
Universal Trial Number (UTN)
Nil.
Trial acronym
Nil.
Linked study record
Nil.

Health condition
Health condition(s) or problem(s) studied:
Chronic joint pain 310346 0
Condition category
Condition code
Musculoskeletal 309075 309075 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GSM powder is a natural health supplement manufactured from sustainably farmed New Zealand Green Shell Mussels (Perna canaliculus). GSM powder is a rich source of naturally occurring bioactive compounds that may have anti-inflammatory, chondroprotective, and/or gastroprotective benefits. Each capsule contains 500 mg of GSM powder. Participants will consume two capsules (1000 mg) each morning with food, as per the manufacturer recommendations for 16 weeks.
Adherence will be monitored in two ways. First, at the end of each week, participants will receive a message via their mobile phone asking "On how many days in the past week have consumed the capsules?" Second, at the end of the intervention participants will be asked to return any unused capsules.
Intervention code [1] 312865 0
Treatment: Other
Comparator / control treatment
The placebo capsules will be identical in their packaging but will contain a sham GSM powder (cornflour). Participants will consume two capsules each morning with food for 16 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 308044 0
The P4 pain rating sale
Timepoint [1] 308044 0
Data will be collected using the P4 at baseline (week 0), once a week during the intervention period (16 weeks), at completion of the intervention (week 16) and at follow-up (week 20).
Primary outcome [2] 308045 0
Analgesic medication use. Participants will complete a short study-specific questionnaire (composite primary outcome measure) indicating the type, amount and dose of analgesic medication they have taken for their joint pain in the past seven (7) days.
Timepoint [2] 308045 0
Data will be collected using the P4 at baseline (week 0), once a week during the intervention period (16 weeks), at completion of the intervention (week 16) and at follow-up (week 20).
Secondary outcome [1] 353810 0
30-second Chair Stand Test
Timepoint [1] 353810 0
Data will be collected at baseline (week 0), on completion of the intervention (week 16) and at follow-up (week 20).
Secondary outcome [2] 353811 0
40-metre Fast-paced Walk Test
Timepoint [2] 353811 0
Data will be collected at baseline (week 0), on completion of the intervention (week 16) and at follow-up (week 20).
Secondary outcome [3] 353812 0
Hip disability and Osteoarthritis Outcome Score
Timepoint [3] 353812 0
Data will be collected at baseline (week 0), on completion of the intervention (week 16) and at follow-up (week 20).
Secondary outcome [4] 353813 0
The Musculoskeletal Health Questionnaire
Timepoint [4] 353813 0
Data will be collected at baseline (week 0), on completion of the intervention (week 16) and at follow-up (week 20).
Secondary outcome [5] 353814 0
Inflammatory Biomarkers. The following cytokines are typically associated with inflammation and will, therefore, be collected using a single blood test (composite secondary outcome measure): C-reactive protein (hs-CRP), tumour necrosis factor alpha (TNF–a), interleukin (IL)-6, IL-2, IL-8, IL-1beta, IL-10 and IL-4.

Once collected the samples will be transported to the AUT Roche lab and analysed in triplicate for red blood cell count, haematocrit and haemoglobin concentration (AcT 5diff, Beckman Coulter, Miami FL, USA), then centrifuged at 4 °C and 3000 rpm for 15 min. Plasma is then extracted and samples are frozen at -20 °C for later analysis. The analysis will include detection and measurement of the following inflammatory biomarkers; C-reactive protein (hs-CRP), tumour necrosis factor alpha (TNF–a), interleukin (IL)-6, IL-2, IL-8, IL-1beta, IL-10 and IL-4.

Samples will be analysed for biomarkers either using a Roche automated clinical analyser or commercially available ELISA kits. Samples will be prepared and inserted into the analyser to be processed automatically. Results will be downloaded in Excel form. For ELISA, analyses will be performed in 96-well plates. Samples will be processed according to manufacturers’ instructions. Electronic automated pipette will be used for sample addition and washing steps to minimise variation. Results will be generated by a multi-functional plate-reader and will be downloaded in Excel format.

Timepoint [5] 353814 0
Data will be collected at baseline (week 0), on completion of the intervention (week 16) and at follow-up (week 20).

Eligibility
Key inclusion criteria
• Have a three-month self-reported history of hip and/or knee joint pain
• Report experiencing pain on more than 15 days in the past month
• Live in the greater Auckland area
• Own a smartphone, tablet or computer with access to the internet
• Have sufficient English or Mandarin language to complete the assessment measures and participate in an interview.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Are, suspect they are, or intend to become pregnant during the course of the study
• Breastfeeding
• Have asthma, gout, liver disease, kidney disease or another medical condition which in the opinion of the researchers would influence the results of the study.
• Have a known, or suspected seafood allergy
• Are taking medication to thin the blood (i.e. aspirin or warfarin)
• Have had, or are planning to have joint replacement surgery in the six months after enrolling in the study
• Are already taking a GSM supplement
• Have a fear of needles or of giving blood.

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 managed using a web-based protocol, with random number codes. The participant group allocation will be sent to the sponsor who will provide the RO with individually coded, GSM power capsules and sham GSM power capsules. The codes will indicate who receives which capsules, but only the sponsor will know the group allocation. Group allocation will only be released to the researchers after the completion of the data analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a web-based random number code generator.
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
Sample size was selected because it was deemed appropriated to test the methods and processes for a full-powered randomised controlled trial.

All outcome measures will be descriptively analysed (number, mean, standard deviation, minimum and maximum). Mean differences between pre- and post-intervention data will be calculated, along with their 95% confidence intervals. As this is a pilot study designed to assess the feasibility of the study protocol and inform subsequent power calculations and is not powered to determine clinical efficacy there will be no interferential statistical assessment.

Recruitment
Recruitment status
Not yet recruiting
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] 21010 0
New Zealand
State/province [1] 21010 0
Auckland

Funding & Sponsors
Funding source category [1] 301139 0
Commercial sector/Industry
Name [1] 301139 0
Beyond Capital
Address [1] 301139 0
PO BOX 128268 Remuera, Auckland, 1541
Country [1] 301139 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Auckland University of Technology
Private Bag 92006
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 300761 0
None
Name [1] 300761 0
Nil
Address [1] 300761 0
Nil
Country [1] 300761 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301888 0
Health and Disability Ethics Committee (New Zealand)
Ethics committee address [1] 301888 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 301888 0
New Zealand
Date submitted for ethics approval [1] 301888 0
16/11/2018
Approval date [1] 301888 0
Ethics approval number [1] 301888 0

Summary
Brief summary
This study aims to explore the effect of green shell mussel (GSM: Perna canaliculus – Mytilidae) extract on pain levels and analgesic medication used of people with chronic hip and or knee joint pain. Participants will be blinded to group allocation (intervention group, control group) and will consume two capsules of either the GSM powder or the placebo (corn flour) daily for a period of 16 weeks. We hypothesise that the intervention group (receiving the GSM extract) will report lower pain levels and analgesic use, than the control group.

Trial website
Nil.
Trial related presentations / publications
Nil.
Public notes
NIl.

Contacts
Principal investigator
Name 88446 0
Dr Daniel O'Brien
Address 88446 0
Auckland University of Technology
Private Bag 92006
Auckland 1142
New Zealand
Country 88446 0
New Zealand
Phone 88446 0
+64 21815717
Fax 88446 0
Email 88446 0
dobrien@aut.ac.nz
Contact person for public queries
Name 88447 0
Dr Daniel O'Brien
Address 88447 0
Auckland University of Technology
Private Bag 92006
Auckland 1142
New Zealand
Country 88447 0
New Zealand
Phone 88447 0
+64 21815717
Fax 88447 0
Email 88447 0
dobrien@aut.ac.nz
Contact person for scientific queries
Name 88448 0
Dr Daniel O'Brien
Address 88448 0
Auckland University of Technology
Private Bag 92006
Auckland 1142
New Zealand
Country 88448 0
New Zealand
Phone 88448 0
+64 21815717
Fax 88448 0
Email 88448 0
dobrien@aut.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Currently we do not plan to share the data to maintain participant privacy.
What supporting documents are/will be available?
No other documents available
Summary results
No Results