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Trial registered on ANZCTR


Registration number
ACTRN12620000413921p
Ethics application status
Submitted, not yet approved
Date submitted
25/02/2020
Date registered
27/03/2020
Date last updated
27/03/2020
Date data sharing statement initially provided
27/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of green-shell mussel on joint health in elderly women
Scientific title
The Effect of Green Shell Mussel powder Versus Control On Cartilage Biomarker Responses And Inflammation In Elderly Women
Secondary ID [1] 300574 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 316304 0
Condition category
Condition code
Musculoskeletal 314572 314572 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 capsules daily, each containing 0.5 gram of flash-dried powder from whole green shell mussel meat (a total of 3 grams per day) for 12 weeks to be taken orally with meals
Subject diaries will be dispensed to each subject at randomization for subjects to record their capsule intake on each day empty containers will be collected. At the week 6 and 12, the subject will return their unused capsule to researcher to assess the rate of the compliance. At week 6, and 12 consumptions record diaries will be cross-checked with subject
Intervention code [1] 316879 0
Prevention
Intervention code [2] 317026 0
Treatment: Other
Comparator / control treatment
sunflower seed powder
Control group
Placebo

Outcomes
Primary outcome [1] 322902 0
Change in serum level of C-telopeptide of type II collagen (CTx-II) assessed by enzyme-linked immunosorbent assay (ELISA )
Timepoint [1] 322902 0
Baseline (week 0), 6 weeks post commencement of taking supplement, 12 weeks post commencement of taking supplement
Primary outcome [2] 322903 0
Change in serum level of type II procollagen (CP-II) assessed by enzyme-linked immunosorbent assay (ELISA )
Timepoint [2] 322903 0
Baseline (week 0), 6 weeks post commencement of taking supplement, 12 weeks post commencement of taking supplement
Primary outcome [3] 322904 0
Change in serum level of cartilage oligomeric matrix protein (COMP) assessed by enzyme-linked immunosorbent assay (ELISA )
Timepoint [3] 322904 0
Baseline (week 0), 6 weeks post commencement of taking supplement, 12 weeks post commencement of taking supplement
Secondary outcome [1] 380200 0
Change in plasma level of inflammatory marker C-reactive protein (hs-CRP) assessed by electrochemiluminescence immunoassay (ECLIA)
Timepoint [1] 380200 0
Baseline (week 0), and 12 weeks post commencement of taking supplement
Secondary outcome [2] 380202 0
Change in plasma level of C-telopeptide of type I collagen (CTx-I) assessed by Roche Elecsys .
Timepoint [2] 380202 0
Baseline (week 0), and 12 weeks post commencement of taking supplement
Secondary outcome [3] 380203 0
Change in level of serum soluble transferrin receptor assessed by enzyme-linked immunosorbent assay (ELISA)
Timepoint [3] 380203 0
Baseline (week 0), and 12 weeks post commencement of taking supplement
Secondary outcome [4] 380204 0
Change in body composition (fat/lean mass ratio) measured by full-body Dual-energy X-ray absorptiometry (DXA) scans
Timepoint [4] 380204 0
Baseline (week 0), and 12 weeks post commencement of taking supplement
Secondary outcome [5] 380205 0
Change in knee pain and function measured by Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Timepoint [5] 380205 0
Baseline (week 0), and 12 weeks post commencement of taking supplement
Secondary outcome [6] 380206 0
Joint pain measured by 100 mm visual analogue scale (VAS)
Timepoint [6] 380206 0
Baseline (week 0), and 12 weeks post commencement of taking supplement
Secondary outcome [7] 380207 0
Change in plasma lipid and polar metabolites profiles measured by metabolomics analysis using liquid chromatography–mass spectrometry (LC–MS)
Timepoint [7] 380207 0
Baseline (week 0), and 12 weeks post commencement of taking supplement
Secondary outcome [8] 380210 0
Change in gene expression of IL-10 assessed by the real-time polymerase chain reaction (PCR) using the white blood cell
Timepoint [8] 380210 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [9] 380211 0
plasma level of 25 (OH) vitamin D3 measured by isotope-dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)
Timepoint [9] 380211 0
Measured at the baseline (week 0) only
Secondary outcome [10] 380212 0
plasma level of parathyroid hormone (PTH) assessed by electrochemiluminescence immunoassay using the plasma
Timepoint [10] 380212 0
Measured at the baseline (week 0) only
Secondary outcome [11] 380213 0
Change in gene expression IL-1ß, assessed by the real-time polymerase chain reaction (PCR) using the white blood cells
Timepoint [11] 380213 0
Baseline (week 0), and 12 weeks post commencement of taking supplement
Secondary outcome [12] 380813 0
Change in the urinary level of creatinine assessed by routine laboratory methods (Primary outcome)
Timepoint [12] 380813 0
Baseline (week 0), 6 weeks post commencement of taking the supplement, 12 weeks post commencement of taking the supplement (Primary timepoint)
Secondary outcome [13] 380814 0
Change in the urinary level of creatinine assessed by routine laboratory methods
(primary outcome)
Timepoint [13] 380814 0
Baseline (week 0), 6 weeks post commencement of taking supplement, 12 weeks post commencement of taking supplement (primary timepoint)
Secondary outcome [14] 380815 0
Change in plasma level of IL-1ß will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay
Timepoint [14] 380815 0
Baseline (week 0) and 12 weeks post commencement of taking supplement
Secondary outcome [15] 380816 0
Change in plasma level of IFN-a2 will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay
Timepoint [15] 380816 0
Baseline (week 0), and 12 weeks post commencement of taking supplement
Secondary outcome [16] 380817 0
Change in plasma level of IFN-gamma will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay
Timepoint [16] 380817 0
Baseline (week 0), and 12 weeks post commencement of taking supplement
Secondary outcome [17] 380818 0
Change in plasma level of TNF-a will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay
Timepoint [17] 380818 0
Baseline (week 0), and 12 weeks post commencement of taking the supplement
Secondary outcome [18] 380819 0
Change in plasma level of MCP-1 will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay
Timepoint [18] 380819 0
Baseline (week 0) and 12 weeks post commencement of taking supplement
Secondary outcome [19] 380820 0
Change in plasma level of IL-6 will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay
Timepoint [19] 380820 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [20] 380821 0
Change in plasma level of IL-8 assays will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay
Timepoint [20] 380821 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [21] 380822 0
Change in plasma level of IL-10 assays will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay
Timepoint [21] 380822 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [22] 380823 0
Change in plasma level of IL-12p70 assays will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay
Timepoint [22] 380823 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [23] 380824 0
Change in plasma level of IL-17A, will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay
Timepoint [23] 380824 0

Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [24] 380825 0
Change in plasma level of IL-18 assays will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay
Timepoint [24] 380825 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [25] 380826 0
Change in plasma level of IL-23 assays will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay
Timepoint [25] 380826 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [26] 380827 0
Change in plasma level of IL-33 will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay
Timepoint [26] 380827 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [27] 380829 0
Change in level of serum Alanine transaminase (ALT) measured by Assay kit
Timepoint [27] 380829 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [28] 380830 0
Change in serum level of Aspartate transaminase (AST) measured by Assay kit
Timepoint [28] 380830 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [29] 380831 0
Change in level of serum gamma-glutamyl transferase (GGT) measured by Assay kit
Timepoint [29] 380831 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [30] 380832 0
Change in level of serum Alkaline phosphatase (ALP)) measured by Assay kit
Timepoint [30] 380832 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [31] 380833 0
Change in level of serum albumin measured by Assay kit
Timepoint [31] 380833 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [32] 380834 0
Change in level of serum creatinine measured by Assay kit
Timepoint [32] 380834 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [33] 380835 0
Change in level of serum glucose measured by Assay kit
Timepoint [33] 380835 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [34] 380836 0
Change in level of serum Low-density lipoprotein cholesterol, (LDL-c)
measured by Assay kit
Timepoint [34] 380836 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [35] 380837 0
Change in level of serum high-density lipoprotein cholesterol (HDL-c)
measured by Assay kit
Timepoint [35] 380837 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [36] 380838 0
Change in level of serum triglycerides measured by Assay kit
Timepoint [36] 380838 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [37] 380839 0
Change in gene expression of IL-6, assessed by the real-time polymerase chain reaction (PCR) using the white blood cell
Timepoint [37] 380839 0
Baseline (week 0), 12 weeks post commencement of taking supplement
Secondary outcome [38] 380840 0
Change in gene expression of TNF-a assessed by the real-time polymerase chain reaction (PCR) using the white blood cell
Timepoint [38] 380840 0
Baseline (week 0), 12 weeks post commencement of taking supplement

Eligibility
Key inclusion criteria
Healthy postmenopausal women who are at least five years menopausal (based on the natural cessation of menstruation)
Aged 55 to 75 years
Having body mass index (BMI) 25-35 kg/m2
With no major illness

Minimum age
55 Years
Maximum age
75 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Formal diagnosis of osteoarthritis or rheumatoid arthritis
-Formal diagnosis of chronic liver or renal function disease (based on medical history or abnormal liver function and kidney function test at screening)
-Formal diagnosis of diabetes mellitus (based on medical history or HbA1c level at screening)
-Having atherosclerosis and cardiac function impairment or bleeding disorder or taking anticoagulants and antiplatelets e.g. warfarin ,aspirin
-A history of allergy to Mussels or seafood.
-History of injury or trauma to joint
-Taking supplements for joint health e.g. Green Lipped mussel, Glucosamine, chondroitin, or Collagen and unwilling to stop these 4 weeks before beginning of the trial.
-Using vitamins or mineral or omega-3 supplements regularly and unwilling to stop these 4 weeks before beginning of the trial.
-Currently consuming more than two units of alcohol per day or currently smoking cigarettes.
Currently taking hormone replacement therapy or less than 6 months prior beginning the trial
Continuously taking (everyday) anti-inflammatory drugs; glucocorticoids, and NSAID drugs e,g aspirin, ibuprofen, naproxen, diclofenac, Celebrex.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomized based on a double-blind randomization schedule in which both researchers and participants will be unware of treatment group allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be stratified based on the age and BMI and, each stratum will be randomized by simple randomisation using a randomisation table created by computer software.
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
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The sample size calculation applies to CTx-II/creatinine, CTx-II/ CP II ratio, and COMP as the primary outcome variables. For CTX-II/ creatinine as well as CTx-II/ CPII a sample size of 24 is required to detect a 20% difference from baseline and a power of 80%. 25 subjects will be recruited for each group. For COMP as well as CP-II a sample size of 7 is required to detect a 20% difference from baseline.
Statistical analysis will be performed using IBM statistics software version 25 (Armonk, NY, USA). Participant characteristics will be presented as mean and standard deviation (mean, SD). Data will be analyzed by one-way ANOVA or Student’s t-test for variable with normal distribution and Kruskal-Wallis and Mann-Whitney U test for variable without normal distribution. Tukey’s t-test will be used to test whether difference from baseline for each treatment was different from zero, indicating that the mean changed over time.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22361 0
New Zealand
State/province [1] 22361 0
Palmerston North

Funding & Sponsors
Funding source category [1] 304988 0
Other Collaborative groups
Name [1] 304988 0
The High-Value Nutrition (HVN)
Address [1] 304988 0
The High-Value Nutrition Ko Nga Kai Whai Painga operations team is based at The Liggins Institute at the University of Auckland, Building 505, 85 Park Rd, Grafton, Auckland.
Country [1] 304988 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
National Science Challenge, High Value Nutrition (HVN) “Musseling up: high-value Greenshell Mussel Foods”,
Address
The High-Value Nutrition Ko Nga Kai Whai Painga operations team are based at The Liggins Institute at the University of Auckland, Building 505, 85 Park Rd, Grafton, Auckland
Country
New Zealand
Secondary sponsor category [1] 305349 0
Other Collaborative groups
Name [1] 305349 0
Cawthron Institute
Address [1] 305349 0
98 Halifax Street East, The Wood, Nelson 7010, New Zealand
Country [1] 305349 0
New Zealand
Secondary sponsor category [2] 305415 0
Commercial sector/Industry
Name [2] 305415 0
Sanford Ltd
Address [2] 305415 0
22 Jellicoe Street, Auckland CBD, Auckland 1010,New Zealand
Country [2] 305415 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305393 0
Massey University Human Ethics Committee: Southern A
Ethics committee address [1] 305393 0
Dr Negar Partow, Chair, Massey University Human Ethics Committee: Southern A,
Telephone 04 801 5799 x 63363 or email:
humanethicsoutha@massey.ac.nz
Ethics committee country [1] 305393 0
New Zealand
Date submitted for ethics approval [1] 305393 0
27/01/2020
Approval date [1] 305393 0
Ethics approval number [1] 305393 0

Summary
Brief summary
Osteoarthritis (OA) is the most common type of joint disease, contributing to progressive pain and disability in the elderly. In New Zealand, OA is affecting 10.2% of the adult population and the incidence escalating with age, and obesity causing the large health-related quality of life loss in NZ. The prevalence of OA is generally higher in women compared to men, as the incidence tend to consistently increase, particularly following menopause, likely due to losing the protective effect of estrogen on joint tissue.
There is no cure for OA and the conventional treatment only used for symptom management. Oil extract from the Greenshell mussel (GSM), a native New Zealand shellfish, has been effective to reduce OA symptoms. A recent animal study showed flash-dried powder from whole GSM meat has preventive effects against the early-stage of metabolic-associated OA. In this study adding GSM powder into the diet of rats actively developing diet-induced OA reduced the cartilage degradation marker. Results from this preliminary study support the potential for an intervention study feeding human subjects with the whole meat GSM powder in order to attenuate the development of OA in a high-risk population.
Therefore, this study aims to evaluate the effects of flash-dried whole meat GSM powder (3 g/day) or identical placebo for 12 weeks on cartilage and bone biomarkers, inflammation, body composition, health parameters, knee function and joint pain in healthy overweight/obese postmenopausal women. Data will be collected using questionnaires to assess the demographic detail, dietary intake, knee function, and pain. Blood (20 ml) and spot urine samples will be collected at the beginning, week 6 and week 12 to measure the biomarkers of cartilage, bone, and inflammation. Dual-energy X-ray absorptiometry (DXA) will be used at the beginning and week 12 for body composition (fat/lean ratio) measurement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100222 0
Miss Maryam Abshirini
Address 100222 0
School of Health Sciences, College
of Health, Massey University, Private Bag 11222,
Palmerston North 4442, New Zealand
Country 100222 0
New Zealand
Phone 100222 0
+64225952199
Fax 100222 0
Email 100222 0
Maryam.Abshirini.1@uni.massey.ac.nz
Contact person for public queries
Name 100223 0
Miss Maryam Abshirini
Address 100223 0
School of Health Sciences, College
of Health, Massey University, Private Bag 11222,
Palmerston North 4442, New Zealand
Country 100223 0
New Zealand
Phone 100223 0
+64225952199
Fax 100223 0
Email 100223 0
Maryam.Abshirini.1@uni.massey.ac.nz
Contact person for scientific queries
Name 100224 0
Prof Marlena Kruger
Address 100224 0
School of Health Sciences, College
of Health, Massey University, Private Bag 11222,
Palmerston North 4442, New Zealand
Country 100224 0
New Zealand
Phone 100224 0
+6469517571
Fax 100224 0
Email 100224 0
M.C.Kruger@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal, for IPD meta-analysis
How or where can data be obtained?
access subject to approvals by Principal Investigator Maryam.Abshirini.1@uni.massey.ac.nz
What supporting documents are/will be available?
No other documents available
Summary results
No Results