A randomised trial comparing the effect of green-lipped mussel and glucosamine in treating osteoarthritis of the knee and assessing if this correlates to the nutraceuticals improving gut integrity
A Phase-I Randomised, Comparison Pilot Trial Evaluating the Efficacy of Nutraceutical Compounds in patients with Osteoarthritis of the Knee – Therapeutic Outcome Measures Correlated to Gastrointestinal Integrity.
The University of Queensland
40 participants
Jun 1, 2011
Interventional
Conditions
Summary
The purpose of the trial is to compare the efficacy of a green-lipped mussel (GLM) extract to a glucosamine sulphate preparation in patients with osteoarthritis (OA) of the knee(s) and to determine if gastrointestinal dysfunction (particularly altered gut flora) plays a role in the therapuetic outcomes. Gastrointestinal dysfunction is reported in OA patients and preliminary data has shown GLM significantly improves gut function. This comparative trial will investigate the gut flora in patients before and after supplementation to see if the nutaceuticals are therapeutically affecting gut flora and function as a mechanism of action of decreasing inflammation and improving pain and stiffness indices in OA patients.
Eligibility
Inclusion Criteria2
- Not taking any form of herbal/multivitamin, fish oil, probiotic, glucosamine or GLM therapy within the past 2 weeks prior to the study enrolment
- Confirmed osteoarthritis of the knee(s) by appointed Rheumatologist
Exclusion Criteria4
- Concurrent use of any other investigational product(s);
- Active substance abuse (alcohol or drug dependency);
- Breastfeeding or pregnancy,
- Allergies to Shellfish (Mollusks and Crustaceans)
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Interventions
Green-Lipped Mussel extract 3000mg/day 3 capsules taken orally twice per day over 12 weeks
Locations(1)
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ACTRN12611000658910