Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001112954p
Ethics application status
Submitted, not yet approved
Date submitted
8/08/2020
Date registered
27/10/2020
Date last updated
27/10/2020
Date data sharing statement initially provided
27/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Researching the role of Greenshell mussels and selected lifestyle and nutritional factors in participants with early signs and symptoms of knee osteoarthritis (The ROAM Study)
Scientific title
Investigating the effects of Greenshell mussel intake on blood biomarkers of cartilage synthesis, cartilage degradation and inflammation and patient reported outcome and performance measures of pain and functionality in participants with early signs and symptoms of knee osteoarthritis.
Secondary ID [1] 301975 0
None
Universal Trial Number (UTN)
Trial acronym
ROAM (Researching Osteoarthritis and Greenshell Mussels)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 318536 0
Inflammation 318537 0
Condition category
Condition code
Musculoskeletal 316543 316543 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume 3g/day of whole meat greenshell mussel powder in the form of 6 oral capsules 3 times per day (2 with each meal) for 6 months. Participants will complete a compliance dairy and return any unused capsules at the end of the trial to monitor adherence. Polar lipid fatty acid extraction from the blood will also be used to monitor adherence.
Intervention code [1] 318264 0
Treatment: Other
Comparator / control treatment
Participants will consume 3g/day of sunflower seed protein as a placebo in the form of 6 oral capsules 3 times per day (2 with each meal) for 6 months.
Control group
Placebo

Outcomes
Primary outcome [1] 324672 0
Cartilage synthesis biomarker type II procollagen (CP­II) assessed by ELISA assay of participant blood serum.
Timepoint [1] 324672 0
Measured at baseline (0 weeks) and end (26 weeks)
Primary outcome [2] 324673 0
Cartilage degradation biomarkers including c-­telopeptide of type II collagen (CTX­II) and cartilage oligomeric matrix protein (COMP) assessed by ELISA assay of participant blood serum.
Timepoint [2] 324673 0
Measured at baseline (0 weeks ) and end (26 weeks)
Primary outcome [3] 324674 0
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [3] 324674 0
Measured at baseline (0 weeks) and end (26 weeks)
Secondary outcome [1] 385378 0
Measure of Intermittent and Constant Pain (ICOAP). This will be a primary outcome measure.
Timepoint [1] 385378 0
Measured at baseline (0 weeks) and end (26 weeks)
Secondary outcome [2] 385379 0
Visual Analog Scale for Pain (VAS). This will be a primary outcome measure.
Timepoint [2] 385379 0
Measured at baseline (0 weeks) and end (26 weeks)
Secondary outcome [3] 386598 0
Composite assessment of physical function including 30 second chair stand test, stair climb test and 40m fast paced walk test. This will be a primary outcome measure.
Timepoint [3] 386598 0
Measured at baseline (0 weeks) and end (26 weeks)
Secondary outcome [4] 386601 0
Inflammatory potential of the diet measured using the dietary inflammatory index (DII)
Timepoint [4] 386601 0
Measured at baseline (0 weeks) and end (26 weeks)
Secondary outcome [5] 386602 0
Inflammatory markers including cytokines IL-1a, IL-1ß, IL-18 and TNF-a assessed by laboratory analysis of participants blood serum.
Timepoint [5] 386602 0
Measured at baseline (0 weeks) and end (26 weeks)

Eligibility
Key inclusion criteria
Healthy women and men aged 60-74years showing early signs and symptoms of OA assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS). KOOS score <94
Minimum age
60 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Not be allergic to mussels or seafood
• Have no history of trauma to knee or hip joints
• Not have a formal diagnosis of osteoarthritis or rheumatoid arthritis by a clinician
• Not be taking joint health supplements or vitamin, mineral or omega­3 supplements or be willing to stop for 4 weeks before the study commences
• Not regularly taking anti-inflammatory drugs (any anti-inflammatory medications should be noted in the compliance diary)
• Must be proficient in English

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation was applied to CTX-II/creatinine, COMP and KOOS data as primary outcome variables. For CTX-II/creatinine a sample size of 60 is required to detect a 20% difference between two treatment groups and a power of 95%. For COMP a sample size of 17 is required to detect a 20% difference from baseline and a power of 95%. For KOOS a sample size of 47 is required to detect a clinically significant difference and a power of 90%. A sample size of 80 per group, i.e. 160 participants in total has been decided to allow for those that discontinue.
Data will be analysed using repeated measures analysis on SPSS.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/11/2020
Actual
Date of last participant enrolment
Anticipated
1/03/2021
Actual
Date of last data collection
Anticipated
1/10/2021
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 22817 0
New Zealand
State/province [1] 22817 0
Auckland

Funding & Sponsors
Funding source category [1] 306398 0
Government body
Name [1] 306398 0
National Science Challenge, High Value Nutrition
Country [1] 306398 0
New Zealand
Funding source category [2] 306400 0
Commercial sector/Industry
Name [2] 306400 0
Sanford Limited
Country [2] 306400 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University, Manawatu, Tennent Drive, Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 306905 0
None
Name [1] 306905 0
Address [1] 306905 0
Country [1] 306905 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306600 0
Health and Disability Ethics Committee
Ethics committee address [1] 306600 0
Health and Disability Ethics Committee
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 306600 0
New Zealand
Date submitted for ethics approval [1] 306600 0
17/09/2020
Approval date [1] 306600 0
Ethics approval number [1] 306600 0

Summary
Brief summary
To evaluate the joint­-sparing effects of 26 weeks of daily intake of flash­dried powder from whole GSM meat (3 gram per day), in older (60-74yrs) healthy adults with early signs or symptoms of osteoarthritis. This will be achieved by monitoring changes in cartilage markers of degradation and synthesis: including type II procollagen (CP­II), C­telopeptide of type II collagen (CTX­II) and cartilage oligomeric matrix protein (COMP); changes in inflammatory markers: including cytokines IL-1a, IL-1ß, IL-18 and TNF-a; changes in patient reported outcome measures (PROMs): including the Knee Injury and Osteoarthritis Score (KOOS), Measure of Intermittent and Constant Pain (ICOAP) and Visual Analog Scale for Pain (VAS) and lastly changes in performance outcome measures measured by the OARSI physical function assessment tests: 30 second chair stand test, stair climb test and 40m fast paced walk test.

The secondary objective is to look at the association between the inflammatory potential of the diet, inflammatory and cartilage biomarkers, PROMS and performance outcome measures for those with early signs and symptoms of OA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104418 0
A/Prof Pamela von Hurst
Address 104418 0
School of Human Nutrition, Level 1, SNW Building, Massey University East Precinct, Albany Campus, Albany Expressway, Albany, Auckland 0632
Country 104418 0
New Zealand
Phone 104418 0
+64 9 213 6859
Fax 104418 0
Email 104418 0
P.R.vonHurst@massey.ac.nz
Contact person for public queries
Name 104419 0
Cassie Slade
Address 104419 0
School of Human Nutrition, Level 1, SNW Building, Massey University East Precinct, Albany Campus, Albany Expressway, Albany, Auckland 0632
Country 104419 0
New Zealand
Phone 104419 0
+64 9 213 6859
Fax 104419 0
Email 104419 0
c.slade2@massey.ac.nz
Contact person for scientific queries
Name 104420 0
Cassie Slade
Address 104420 0
School of Human Nutrition, Level 1, SNW Building, Massey University East Precinct, Albany Campus, Albany Expressway, Albany, Auckland 0632
Country 104420 0
New Zealand
Phone 104420 0
+64 9 213 6859
Fax 104420 0
Email 104420 0
c.slade2@massey.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


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.