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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteoarthritis

Condition category

Condition code

Musculoskeletal

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]

Prevention

Intervention code [2]

Treatment: Other

Comparator / control treatment

sunflower seed powder

Control group

Placebo

Outcomes

Primary outcome [1]

Change in serum level of C-telopeptide of type II collagen (CTx-II) assessed by enzyme-linked immunosorbent assay (ELISA )

Timepoint [1]

Baseline (week 0), 6 weeks post commencement of taking supplement, 12 weeks post commencement of taking supplement

Primary outcome [2]

Change in serum level of type II procollagen (CP-II) assessed by enzyme-linked immunosorbent assay (ELISA )

Timepoint [2]

Baseline (week 0), 6 weeks post commencement of taking supplement, 12 weeks post commencement of taking supplement

Primary outcome [3]

Change in serum level of cartilage oligomeric matrix protein (COMP) assessed by enzyme-linked immunosorbent assay (ELISA )

Timepoint [3]

Baseline (week 0), 6 weeks post commencement of taking supplement, 12 weeks post commencement of taking supplement

Secondary outcome [1]

Change in plasma level of inflammatory marker C-reactive protein (hs-CRP) assessed by electrochemiluminescence immunoassay (ECLIA)

Timepoint [1]

Baseline (week 0), and 12 weeks post commencement of taking supplement

Secondary outcome [2]

Change in plasma level of C-telopeptide of type I collagen (CTx-I) assessed by Roche Elecsys .

Timepoint [2]

Baseline (week 0), and 12 weeks post commencement of taking supplement

Secondary outcome [3]

Change in level of serum soluble transferrin receptor assessed by enzyme-linked immunosorbent assay (ELISA)

Timepoint [3]

Baseline (week 0), and 12 weeks post commencement of taking supplement

Secondary outcome [4]

Change in body composition (fat/lean mass ratio) measured by full-body Dual-energy X-ray absorptiometry (DXA) scans

Timepoint [4]

Baseline (week 0), and 12 weeks post commencement of taking supplement

Secondary outcome [5]

Change in knee pain and function measured by Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire

Timepoint [5]

Baseline (week 0), and 12 weeks post commencement of taking supplement

Secondary outcome [6]

Joint pain measured by 100 mm visual analogue scale (VAS)

Timepoint [6]

Baseline (week 0), and 12 weeks post commencement of taking supplement

Secondary outcome [7]

Change in plasma lipid and polar metabolites profiles measured by metabolomics analysis using liquid chromatography–mass spectrometry (LC–MS)

Timepoint [7]

Baseline (week 0), and 12 weeks post commencement of taking supplement

Secondary outcome [8]

Change in gene expression of IL-10 assessed by the real-time polymerase chain reaction (PCR) using the white blood cell

Timepoint [8]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [9]

plasma level of 25 (OH) vitamin D3 measured by isotope-dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)

Timepoint [9]

Measured at the baseline (week 0) only

Secondary outcome [10]

plasma level of parathyroid hormone (PTH) assessed by electrochemiluminescence immunoassay using the plasma

Timepoint [10]

Measured at the baseline (week 0) only

Secondary outcome [11]

Change in gene expression IL-1ß, assessed by the real-time polymerase chain reaction (PCR) using the white blood cells

Timepoint [11]

Baseline (week 0), and 12 weeks post commencement of taking supplement

Secondary outcome [12]

Change in the urinary level of creatinine assessed by routine laboratory methods (Primary outcome)

Timepoint [12]

Baseline (week 0), 6 weeks post commencement of taking the supplement, 12 weeks post commencement of taking the supplement (Primary timepoint)

Secondary outcome [13]

Change in the urinary level of creatinine assessed by routine laboratory methods
(primary outcome)

Timepoint [13]

Baseline (week 0), 6 weeks post commencement of taking supplement, 12 weeks post commencement of taking supplement (primary timepoint)

Secondary outcome [14]

Change in plasma level of IL-1ß will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay

Timepoint [14]

Baseline (week 0) and 12 weeks post commencement of taking supplement

Secondary outcome [15]

Change in plasma level of IFN-a2 will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay

Timepoint [15]

Baseline (week 0), and 12 weeks post commencement of taking supplement

Secondary outcome [16]

Change in plasma level of IFN-gamma will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay

Timepoint [16]

Baseline (week 0), and 12 weeks post commencement of taking supplement

Secondary outcome [17]

Change in plasma level of TNF-a will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay

Timepoint [17]

Baseline (week 0), and 12 weeks post commencement of taking the supplement

Secondary outcome [18]

Change in plasma level of MCP-1 will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay

Timepoint [18]

Baseline (week 0) and 12 weeks post commencement of taking supplement

Secondary outcome [19]

Change in plasma level of IL-6 will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay

Timepoint [19]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [20]

Change in plasma level of IL-8 assays will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay

Timepoint [20]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [21]

Change in plasma level of IL-10 assays will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay

Timepoint [21]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [22]

Change in plasma level of IL-12p70 assays will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay

Timepoint [22]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [23]

Change in plasma level of IL-17A, will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay

Timepoint [23]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [24]

Change in plasma level of IL-18 assays will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay

Timepoint [24]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [25]

Change in plasma level of IL-23 assays will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay

Timepoint [25]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [26]

Change in plasma level of IL-33 will be prepared using BioLegend LEGENDplex™ Multi-Analyte Flow Assay

Timepoint [26]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [27]

Change in level of serum Alanine transaminase (ALT) measured by Assay kit

Timepoint [27]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [28]

Change in serum level of Aspartate transaminase (AST) measured by Assay kit

Timepoint [28]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [29]

Change in level of serum gamma-glutamyl transferase (GGT) measured by Assay kit

Timepoint [29]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [30]

Change in level of serum Alkaline phosphatase (ALP)) measured by Assay kit

Timepoint [30]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [31]

Change in level of serum albumin measured by Assay kit

Timepoint [31]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [32]

Change in level of serum creatinine measured by Assay kit

Timepoint [32]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [33]

Change in level of serum glucose measured by Assay kit

Timepoint [33]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [34]

Change in level of serum Low-density lipoprotein cholesterol, (LDL-c)
measured by Assay kit

Timepoint [34]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [35]

Change in level of serum high-density lipoprotein cholesterol (HDL-c)
measured by Assay kit

Timepoint [35]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [36]

Change in level of serum triglycerides measured by Assay kit

Timepoint [36]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [37]

Change in gene expression of IL-6, assessed by the real-time polymerase chain reaction (PCR) using the white blood cell

Timepoint [37]

Baseline (week 0), 12 weeks post commencement of taking supplement

Secondary outcome [38]

Change in gene expression of TNF-a assessed by the real-time polymerase chain reaction (PCR) using the white blood cell

Timepoint [38]

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

Sex

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

1/05/2020

Actual

Date of last participant enrolment

Anticipated

1/09/2020

Actual

Date of last data collection

Anticipated

28/02/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Palmerston North

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

The High-Value Nutrition (HVN)

Address [1]

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]

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]

Other Collaborative groups

Name [1]

Cawthron Institute

Address [1]

98 Halifax Street East, The Wood, Nelson 7010, New Zealand

Country [1]

New Zealand

Secondary sponsor category [2]

Commercial sector/Industry

Name [2]

Sanford Ltd

Address [2]

22 Jellicoe Street, Auckland CBD, Auckland 1010,New Zealand

Country [2]

New Zealand

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Massey University Human Ethics Committee: Southern A

Ethics committee address [1]

 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]

New Zealand

Date submitted for ethics approval [1]

27/01/2020

Approval date [1]

Ethics approval number [1]

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

Miss Maryam Abshirini

Address

School of Health Sciences, College
of Health, Massey University, Private Bag 11222,
Palmerston North 4442, New Zealand

Country

New Zealand

Phone

+64225952199

Fax

[email protected]

Contact person for public queries

Name

Maryam Abshirini

Address

School of Health Sciences, College
of Health, Massey University, Private Bag 11222,
Palmerston North 4442, New Zealand

Country

New Zealand

Phone

+64225952199

Fax

[email protected]

Contact person for scientific queries

Name

Marlena Kruger

Address

School of Health Sciences, College
of Health, Massey University, Private Bag 11222,
Palmerston North 4442, New Zealand

Country

New Zealand

Phone

+6469517571

Fax

[email protected]

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 [email protected]

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4791	Study results article	Yes		effect of green shell mussel intervention on bioma... [More Details]	379291-(Uploaded-28-10-2023-12-32-16)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effect of GreenshellTM mussel on osteoarthritis biomarkers and inflammation in healthy postmenopausal women: a study protocol for a randomized double-blind placebo-controlled trial.	2021	https://dx.doi.org/10.1186/s13063-021-05473-5
Embase	Effects of GreenshellTM mussel intervention on biomarkers of cartilage metabolism, inflammatory markers and joint symptoms in overweight/obese postmenopausal women: A randomized, double-blind, and placebo-controlled trial.	2022	https://dx.doi.org/10.3389/fmed.2022.1063336
Embase	Effect of green-lipped mussel (Perna canaliculus) supplementation on faecal microbiota, body composition and iron status markers in overweight and obese postmenopausal women: a randomised, double-blind, placebo-controlled trial.	2023	https://dx.doi.org/10.1017/jns.2023.41

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically