Abstract
BackgroundNew 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.MethodFifty 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.DiscussionThis 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 registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000413921p. Registration on 27 March 2020.
Highlights
New Zealand GreenshellTM mussels (GSM; Perna canaliculus) have recently been shown to decrease cartilage degradation in a rat model of induced metabolic osteoarthritis (MetOA)
Sample size The sample size calculation applies to CTX-II/creatinine, CTX-II/procollagen II C-propeptide (PIICP) referred as (CPII) C-propeptide (PIICP) also referred as (CPII) ratio, and cartilage oligomeric matrix protein (COMP) as the primary outcome variables
To the best of our knowledge, this is the first randomized controlled trial that will determine the effect of whole meat GSM powder on cartilage metabolism, bone resorption, and inflammation biomarkers in overweight and obese postmenopausal women who at high risk of developing OA
Summary
New Zealand GreenshellTM mussels (GSM; Perna canaliculus) have recently been shown to decrease cartilage degradation in a rat model of induced metabolic osteoarthritis (MetOA). 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. It is estimated to affect 33.6% of the elderly over 65 years of age [1, 2]. Estrogen depletion is an important risk factor for OA, possibly due to the presence of estrogen receptors (ERs) in joint tissues [5]
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