Effect of GreenshellTM mussel on osteoarthritis biomarkers and inflammation in healthy postmenopausal women: a study protocol for a randomized double-blind placebo-controlled trial

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dc.citation.issue1
dc.citation.volume22
dc.contributor.authorAbshirini M
dc.contributor.authorCoad J
dc.contributor.authorWolber FM
dc.contributor.authorvon Hurst P
dc.contributor.authorMiller MR
dc.contributor.authorTian HS
dc.contributor.authorKruger MC
dc.coverage.spatialEngland
dc.date.accessioned2023-07-16T21:29:27Z
dc.date.accessioned2023-09-04T01:40:42Z
dc.date.available2021-07-28
dc.date.available2023-07-16T21:29:27Z
dc.date.available2023-09-04T01:40:42Z
dc.date.issued2021-12
dc.date.updated2023-07-11T22:46:31Z
dc.description2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.en
dc.description.abstractBACKGROUND: New Zealand Greenshell™ mussels (GSM; Perna canaliculus) have recently been shown to decrease cartilage degradation in a rat model of induced metabolic osteoarthritis (MetOA). However, this effect has not been investigated in human subjects. This study aims to determine the effect of GSM powder on biomarkers of cartilage metabolism, bone resorption, and inflammation in New Zealand healthy overweight/obese postmenopausal women who are at early stage or at high risk of OA. METHOD: Fifty overweight or obese (BMI 25-35 kg/m2) postmenopausal women (aged 55-75 years) will be recruited by advertisement. Participants will be randomized based on a double-blind randomization schedule and stratified randomization based on BMI and age distribution. The participant will be assigned with a 1:1 allocation ratio to receive 3 g/d whole meat GSM powder or placebo (sunflower seed protein) for 12 weeks. Data on socio-demographics, physical activity, and dietary intake will be collected for each subject. Cartilage turnover biomarkers [(C-telopeptide of type II collagen (CTX-II), C-propeptide of type II procollagen (CPII), Cartilage oligomeric matrix protein (COMP)], and bone resorption marker (CTX-I) will be measured in blood and urine samples. Inflammatory status (hs-CRP and cytokine panel) will be assessed and iron status will be measured. Body composition including fat mass (FM), lean mass (LM), and fat percentage will be measured using dual-energy X-ray absorptiometry (DXA). Joint pain and knee function will be assessed using a 100-mm visual analog scale (VAS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, respectively. DISCUSSION: This trial will be the first to explore the effects of whole meat GSM powder on cartilage turnover, bone resorption, and inflammation biomarkers in overweight/obese postmenopausal women. The results from this trial will provide evidence on the efficacy of GSM in the prevention of OA. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000413921p . Registration on 27 March 2020.
dc.description.confidentialfalse
dc.edition.editionDecember 2021
dc.format.extent498-
dc.identifierARTN 498
dc.identifier10.1186/s13063-021-05473-5
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/34321048
dc.identifier.citationAbshirini M, Coad J, Wolber FM, von Hurst P, Miller MR, Tian HS, Kruger MC. (2021). Effect of GreenshellTM mussel on osteoarthritis biomarkers and inflammation in healthy postmenopausal women: a study protocol for a randomized double-blind placebo-controlled trial.. Trials. 22. 1. (pp. 498-).
dc.identifier.doi10.1186/s13063-021-05473-5
dc.identifier.eissn1745-6215
dc.identifier.elements-typejournal-article
dc.identifier.harvestedMassey_Dark
dc.identifier.issn1745-6215
dc.identifier.urihttp://hdl.handle.net/10179/19869
dc.languageeng
dc.publisherBioMed Central Ltd
dc.publisher.urihttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05473-5
dc.relation.isPartOfTrials
dc.rights(c) The author/s CC BY 4.0en
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en
dc.subjectBiomarker
dc.subjectGreen-lipped mussel
dc.subjectGreenshell mussel
dc.subjectInflammation
dc.subjectOsteoarthritis
dc.subjectAnimals
dc.subjectAustralia
dc.subjectBiomarkers
dc.subjectBivalvia
dc.subjectDouble-Blind Method
dc.subjectHumans
dc.subjectInflammation
dc.subjectNew Zealand
dc.subjectOsteoarthritis, Knee
dc.subjectPostmenopause
dc.subjectRandomized Controlled Trials as Topic
dc.subjectRats
dc.titleEffect of GreenshellTM mussel on osteoarthritis biomarkers and inflammation in healthy postmenopausal women: a study protocol for a randomized double-blind placebo-controlled trial
dc.typeJournal article
pubs.elements-id447902
pubs.organisational-groupOther
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