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)

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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620001112954

Acronym

ROAM (Researching Osteoarthritis and Greenshell Mussels)

Enrollment

160

Registered

2020-10-27

Start date

2020-11-09

Completion date

2021-03-01

Last updated

2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

60 Years to 74 Years

Healthy volunteers

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

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

Outcome results