RecruitingPhase 1ACTRN12611000658910

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.


Sponsor

The University of Queensland

Enrollment

40 participants

Start Date

Jun 1, 2011

Study Type

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

Sex: Both males and femalesMin Age: 40 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two natural supplements for knee osteoarthritis — green-lipped mussel extract and glucosamine sulphate — to find out which one works better for pain and stiffness. Researchers also want to explore whether these supplements help by improving the health of the gut (digestive system), since some evidence suggests gut problems may play a role in osteoarthritis. Stool samples will be collected to measure gut bacteria before and after the supplement. You may be eligible if: - You are between 40 and 80 years of age - You have confirmed osteoarthritis of the knee(s), diagnosed by a rheumatologist - You have not taken herbal supplements, fish oil, probiotics, glucosamine, or green-lipped mussel products in the past 2 weeks You may NOT be eligible if: - You are currently taking any other investigational product - You have active substance abuse (alcohol or drug dependency) - You are pregnant or breastfeeding - You have an allergy to shellfish (mollusks or crustaceans) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Green-Lipped Mussel extract 3000mg/day 3 capsules taken orally twice per day over 12 weeks

Green-Lipped Mussel extract 3000mg/day 3 capsules taken orally twice per day over 12 weeks


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12611000658910


Related Trials