Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000261718
Ethics application status
Approved
Date submitted
28/02/2013
Date registered
5/03/2013
Date last updated
9/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical study to assess the efficacy of a green-lipped mussel (GLM) extract in people with knee osteoarthritis.
Scientific title
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.
Secondary ID [1] 281881 0
None
Universal Trial Number (UTN)
U1111-1139-1638
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 288270 0
Gastrointestinal Symptoms 288271 0
Condition category
Condition code
Musculoskeletal 288622 288622 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286444 0
Treatment: Other
Comparator / control treatment
The placebo treatment group will recieve inactive ingredient capsules (500mg x 3 per day) to be taken orally each morning with breakfast for 12 weeks duration.
The capsules will contain microcrystalline cellulose and a shell fish flavour that does not produce a therapeutic effect.
Control group
Placebo

Outcomes
Primary outcome [1] 288775 0
Knee pain, stiffness and physical function as determined by the Western Ontario McMasters Universities Arthritis Index and Lequesne Algofunctional Index questionnaires
Timepoint [1] 288775 0
baseline, 6 weeks and 12 weeks
Primary outcome [2] 288776 0
Faecal Microbial Bacterial Analysis - to determine bacterial genera and species
Timepoint [2] 288776 0
baseline and 12 weeks
Secondary outcome [1] 300950 0
Gastrointestinal Symptom Rating Scale (GSRS) to determine gastrointestinal symptoms
Timepoint [1] 300950 0
baseline, 6 weeks and 12 weeks
Secondary outcome [2] 300951 0
Numeric Pain Intensity Scale - indicates knee pain between 0 (no pain) and 10 (almost extreme pain)
Timepoint [2] 300951 0
baseline, 6 weeks and 12 weeks
Secondary outcome [3] 300952 0
Intermittent and Constant Osteoarthritis Pain (ICOAP) - distinguishes between two distinct types of pain in osteoarthritis. An aching and fairly constant background pain and a less frequent but more intense and often unpredictable pain
Timepoint [3] 300952 0
baseline, 6 weeks and 12 weeks
Secondary outcome [4] 300953 0
SF-12 Health Questionnaire - to assess physical and mental health status
Timepoint [4] 300953 0
baseline, 6 weeks and 12 weeks
Secondary outcome [5] 300954 0
Consumption of paracetamol (as Panadol osteo)
Timepoint [5] 300954 0
6 weeks and 12 weeks
Secondary outcome [6] 300955 0
Blood safety markers - electrolytes, liver function test, full blood count and inflammatory markers C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)
Timepoint [6] 300955 0
baseline and 12 weeks

Eligibility
Key inclusion criteria
Age 40 years and older with clinical evidence of painful knee (osteoarthritis) OA for at least 6 months (with a pain numerical scale of 4 and above at baseline) and radiographic evidence of knee OA as determined as having a kellgren-Lawrence grade 2- or 3-. Not taking any dietary supplements including fish oils, glucosamine, green-lipped mussel, herbal preparations, antibiotics and probiotics 4 weeks before commencing trial.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
knee replacements(s) of affected knee with OA; intra-articular therapies (knee cortisone injection and arthroscopy) within 3 months of starting the trial; pregnancy; use of illicit drugs; alcohol abuse; shell fish allergy; uncontrolled chronic health conditions i.e. diabetes, hypertension, cardiovascular disease; the inability to with-hold from using non-steroidal antiinflammatory drugs (NSAIDs) for the duration of the trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Advertisements for trial participants will be placed in Brisbane newspapers and magazines. Flyers will also be placed in local Brisbane hospitals such as the Princess Alexandra (PA) Hospital and the Mater. The trial will be advertised on the Arthritis QLD website.

Potential participants will be invited to phone or email their interest to the clinical trial co-ordinator who will assess their initial eligibility. If eligible, potential participants will be asked to attend the PA hospital to have an x-ray taken of their affected knee. If an x-ray has been taken in the previous 6 months they will not be required to have another taken, but must be able to bring their x-ray to the hospital. A rheumatologist at the PA hospital will grade the knee x-ray according to the kellgren-lawrence scale. If the grade is -2 or -3 and the participant meets all other eligibility criteria they will be invited to enrol in the study.

The investigator who will assess participant eligibility will be blinded to participant treatment group allocation. Futhermore, a block randomisation allocation sequence will be generated and held by a researcher not associated or involved with the clinical trial. As recruitment progresses, participants will be allocated to a treatment group that will be provided to the study investigator on a per-participant basis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study statistician not associated with the recruitment phase will generate a block randomisation for a two treatment regime.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In the first instance, independent group t tests will be used to test for differences in changes in scores between the two groups with an intention-to-treat analysis. More robust statistical methologies will be employed if significant differences are found.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/02/2013
Actual
28/02/2013
Date of last participant enrolment
Anticipated
31/01/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 6269 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 286667 0
Commercial sector/Industry
Name [1] 286667 0
Aroma New Zealand Limited
Country [1] 286667 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Aroma New Zealand Limited
Address
12 Senior Place
Bromely, Christchurch 8062
Country
New Zealand
Secondary sponsor category [1] 285449 0
None
Name [1] 285449 0
Address [1] 285449 0
Country [1] 285449 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288742 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 288742 0
Cumbrae-Stewart Building
Research road
Brisbane, QLD 4072
Ethics committee country [1] 288742 0
Australia
Date submitted for ethics approval [1] 288742 0
Approval date [1] 288742 0
25/10/2012
Ethics approval number [1] 288742 0
2012001043
Ethics committee name [2] 288743 0
Metro South Hospital and Health Service Human Research Ethics Committee
Ethics committee address [2] 288743 0
Ipswich Road,
Woolloongabba, QLD 4102
Ethics committee country [2] 288743 0
Australia
Date submitted for ethics approval [2] 288743 0
Approval date [2] 288743 0
25/10/2012
Ethics approval number [2] 288743 0
HREC/12/QPAH/537

Summary
Brief 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.
Trial website
Trial related presentations / publications
1. Coulson et al. Properties of Green-Lipped Mussel extract (Perna canaliculus) and Glucosamine Sulphate in patients with knee Osteoarthritis: therapeutic efficacy and effects on gastrointestinal microbiota profiles. Inflammopharmacology 2013;21(1):79-90.
2. Coulson S, et al. Green-Lipped Mussel (Perna canaliculus) extract efficacy in knee osteoarthritis and improvement in gastrointestinal dysfunction: a pilot study. Inflammopharmacology 2012;20(2):71-6.
3. Coulson S, et al. Gastroinestinal function in musculoskeletal disease - microbiota profiles. In: Australian Rheumatology Association Annual Conference. Gold Coast Australia, 28th Oct 2012.
4. Coulson S,et al. Gastrointestinal function in musculoskeletal disease - microbiota profiles. In: Nutrition Society of Australia, Gut Health Conference. Brisbane, Australia, 23rd Oct 2012.
5. Coulson S, et al. Gastrointestinal microbiota profiles in patients with osteoarthritis - implications for the therapeutic activity of green-lipped mussel (perna canaliculus) and glucosamine. In: 18th International Integrative Medicine Conference. Melbourne, Australia, 31st Aug - 2nd Sep, 2012.
6. Coulson S, et al. Metabolic potential of gastrointestinal microbiota profiles in patients with osteoarthritis - implications for the therapeutic activity of glucosamine and green-lipped mussel. In: The Science of Nutrition in Medicine, 2nd International Conference. Melbourne, Australia, 4-6th May, 2012.
7. Coulson S, et al. Investigating gastrointestinal function and microbiota profiles in patients with osteoarthritis - a role for glucosamine and green-lipped mussel. In: World Congress on Debates and Consensus in Bone, Muscle and Joint Diseases. Barcelona, Spain, 19 - 22 Jan 2012; Pg A22.
8. Coulson S, et al. A randomised phase 1 comparison trial evaluating the efficac of nutraceutical compounds in patients with osteoarthritis of the knee - therapeutic outcome measures correlated to gastrointestinal integrity. In: The Science of Nutrition in Medicine and Healthcare, 1st International Conference. Sydney, Australia, 13-15 May 2011; Pg80.
9. Coulson S, et al. Greem-lipped mussel extract and gastrointestinal function in patients diagnosed with osteoarthritis of the knee. In: 15th International Holistic Health Conference. Melbourne, Australia, 9-11 Oct 2009.
Public notes

Contacts
Principal investigator
Name 37558 0
A/Prof Luis Vitetta
Address 37558 0
Centre for Integrative Clinical and Molecular Medicine
Translational Research Institute (TRI)
Level 5
37 Kent Street
Woolloongabba, 4102
QLD.
Country 37558 0
Australia
Phone 37558 0
+61 07 3443 7922
Fax 37558 0
Email 37558 0
l.vitetta@uq.edu.au
Contact person for public queries
Name 37559 0
Dr Samantha Coulson
Address 37559 0
Centre for Integrative Clinical and Molecular Medicine
Translational Research Institute (TRI)
Level 5
37 Kent street
Woolloongabba, 4102
QLD
Country 37559 0
Australia
Phone 37559 0
+61 047 3443 7922
Fax 37559 0
Email 37559 0
s.coulson@uq.edu.au
Contact person for scientific queries
Name 37560 0
Dr Samantha Coulson
Address 37560 0
Centre for Integrative Clinical and Molecular Medicine
TRI
Level 5
37 Kent street
Woolloongabba, 4102
QLD
Country 37560 0
Australia
Phone 37560 0
+61 07 3443 7922
Fax 37560 0
Email 37560 0
s.coulson@uq.edu.au

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