Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000658910
Ethics application status
Approved
Date submitted
28/06/2011
Date registered
28/06/2011
Date last updated
9/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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.
Secondary ID [1] 262358 0
The University of Queensland HREC 2009000148
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 268060 0
Irritable Bowel Symptoms 268061 0
Condition category
Condition code
Alternative and Complementary Medicine 268205 268205 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Green-Lipped Mussel extract 3000mg/day

3 capsules taken orally twice per day over 12 weeks
Intervention code [1] 266751 0
Treatment: Drugs
Comparator / control treatment
Glucosamine sulphate 3000mg/day

3 capsules taken orally twice per day over 12 weeks
Control group
Active

Outcomes
Primary outcome [1] 268944 0
Faecal Microbial Analysis
Timepoint [1] 268944 0
At baseline before supplementation and at week 12 after commencement of supplements
Primary outcome [2] 268945 0
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) which measures knee pain, knee stiffness and impaired physical function due to knee osteoarthritis.
Timepoint [2] 268945 0
baseline and at week 6 and week 12 after commencement of supplements
Primary outcome [3] 268946 0
Gastrointestinal Symptom Rating Score (GSRS)
Timepoint [3] 268946 0
Baseline, week 6 and week 12
Secondary outcome [1] 276669 0
Lequesne Index questionnaire which measures knee pain, walking distance and daily living in patients with osteoarthritis of the knee.
Timepoint [1] 276669 0
baseline and at week 6 and week 12 after commencement of supplements
Secondary outcome [2] 276670 0
SF-12 short form Health Questionnaire
Timepoint [2] 276670 0
baseline and at week 6 and week 12 after commencement of supplements
Secondary outcome [3] 276891 0
Daily pain score on 5 point likert scale
Timepoint [3] 276891 0
daily for 12 weeks starting from first day of supplementation

Eligibility
Key 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
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised random number generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4166 0
4102

Funding & Sponsors
Funding source category [1] 267324 0
Self funded/Unfunded
Name [1] 267324 0
The Centre for Integrative Clinical and Molecular Medicine, The University of Queensland
Country [1] 267324 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Research and Innovation Division
Cumbrae-Stewart Building (72)
St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 266392 0
Commercial sector/Industry
Name [1] 266392 0
Aroma NZ
Address [1] 266392 0
12 Senior Place
Bromley
Christchurch 8062
Country [1] 266392 0
New Zealand
Other collaborator category [1] 252080 0
Other Collaborative groups
Name [1] 252080 0
Bioscreen Medical
Address [1] 252080 0
Bio21 Molecular Science & Biotechnology Institute
Building 404, Room G6
2Park Drive, University of Melbourne,
Parkville, Victoria, 3010
Country [1] 252080 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269310 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 269310 0
The University of Queensland
Research & Research Training Division
Cumbrae-Stewart Building (72)
St Lucia 4072
Ethics committee country [1] 269310 0
Australia
Date submitted for ethics approval [1] 269310 0
01/02/2011
Approval date [1] 269310 0
22/02/2011
Ethics approval number [1] 269310 0
2009000148

Summary
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.
Trial website
Trial related presentations / publications
Coulson S, Vecchio P, Masci P, Vitetta L. Green–Lipped Muscle Extract and GIT Function in Patients Diagnosed with OA of the Knee. AIMA International Integrative Conference 2009, Abstract Presentation.

Coulson S, Vecchio P, Masci O, Vitetta L. A randomized phase-I/pilot comparison trial evaluating the efficacy of nutraceutical compounds in patients with osteoarthritis of the knee – therapeutic outcome measures correlated to gastrointestinal integrity. International conference on the science of nutrition in medicine and healthcare 2011; Scientific stream and accepted abstracts, pg 80.
Public notes

Contacts
Principal investigator
Name 32730 0
Address 32730 0
Country 32730 0
Phone 32730 0
Fax 32730 0
Email 32730 0
Contact person for public queries
Name 15977 0
Samantha Coulson
Address 15977 0
The Princess Alexandra Hospital
The Centres for health research
Lvl 2, R wing
Ipswich Rd
Woolloongabba 4102
QLD
Country 15977 0
Australia
Phone 15977 0
+61 07 3176 5273
Fax 15977 0
+61 07 3176 6858
Email 15977 0
[email protected]
Contact person for scientific queries
Name 6905 0
samantha coulson
Address 6905 0
The Princess Alexandra Hospital
The Centres for health research
Lvl 2, R wing
Ipswich Rd
Woolloongabba 4102
QLD
Country 6905 0
Australia
Phone 6905 0
+61 07 3176 5273
Fax 6905 0
+61 07 3176 6858
Email 6905 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.