RecruitingPhase 2ACTRN12613000261718

A clinical study to assess the efficacy of a green-lipped mussel (GLM) extract in people with knee osteoarthritis.

A phase IIa double-blind, randomised, placebo-controlled study investigating the efficacy and safety of GlycOmega PLUS supplementation in the treatment of osteoarthritis of the knee.


Sponsor

Aroma New Zealand Limited

Enrollment

110 participants

Start Date

Feb 28, 2013

Study Type

Interventional

Conditions

Summary

We have clinically investigated GlycOmega Plus in two previous clinical trials (with no placebo arm) in participants with knee OA. Both trials demonstrated significant improvement in knee pain, stiffness and physical function at a dose of 3000mg per day for 8-12 weeks. This current trial aims to determine the clinical effectiveness of GlycOmega Plus in treating OA knee pain, stiffness and physical function at a dose of 1500mg for 12 weeks in a randomised placebo controlled design. Further we aim to assess faecal bacterial profiles to determine if participants with OA demonstrate altered bacterial growth and whether influencing bacterial growth with the supplementaion of GlycOmega Plus can be correlated to improve knee OA symptoms.


Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

Osteoarthritis of the knee causes pain, stiffness, and difficulty walking. This trial is testing a natural supplement made from green-lipped mussels (GlycOmega Plus) to see if it can reduce knee pain and improve movement and function. Previous studies without a placebo group showed promising results, and this study uses a proper placebo comparison to confirm whether the supplement truly works. Researchers will also look at gut bacteria to see if the supplement changes the bacterial balance in a way that reduces inflammation. You may be eligible if: - You are 40 to 85 years of age - You have had painful knee osteoarthritis for at least 6 months with a pain score of 4 or above - An x-ray has confirmed you have knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) - You have not taken fish oils, glucosamine, green-lipped mussel, herbal supplements, antibiotics, or probiotics in the last 4 weeks You may NOT be eligible if: - You have had a knee replacement in the affected knee - You have had a cortisone injection or knee surgery in the past 3 months - You are pregnant - You have uncontrolled diabetes, high blood pressure, or cardiovascular disease - You have a shellfish allergy - You are unable to stop taking anti-inflammatory drugs (NSAIDs) for the duration of the trial Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The active treatment group will recieve green-lipped mussel extract capsules (500mg x 3 per day) to be taken orally each morning with breakfast for 12 weeks duration. The capsules will contain whole

The active treatment group will recieve green-lipped mussel extract capsules (500mg x 3 per day) to be taken orally each morning with breakfast for 12 weeks duration. The capsules will contain whole green-lipped mussel meat that has been freeze dried and converted to a powder for encapsulation.


Locations(1)

QLD, Australia

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