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.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000658910

Enrollment

Registered

2011-06-28

Start date

2011-06-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

- 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 criteria

- Concurrent use of any other investigational product(s); - Active substance abuse (alcohol or drug dependency); - Breastfeeding or pregnancy, - Allergies to Shellfish (Mollusks and Crustaceans)

Outcome results