scholarly journals 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 ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Maryam Abshirini ◽  
Jane Coad ◽  
Frances M. Wolber ◽  
Pamela von Hurst ◽  
Matthew R. Miller ◽  
...  

Abstract Background 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.

2021 ◽  
Author(s):  
Maryam Abshirini ◽  
Jane Coad ◽  
Frances M. Wolber ◽  
Pamela von Hurst ◽  
Matthew R Miller ◽  
...  

Abstract Background: New Zealand Greenshell™ mussels (GSM; Perna canaliculus) has 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. Method: Fifty overweight or obese (BMI 25-35 kg/m2) postmenopausal women (aged 55-75 years) will be recruited. They will be randomly assigned 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 Analogue 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 prevention of OA. Trial registration: The study was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) with the number ACTRN12620000413921p. Registration date: 27/03/2020. https://www.anzctr.org.au/Trial/Update/Step1_Update.aspx?id=379291


Author(s):  
Sook Yee Lim ◽  
Yoke Mun Chan ◽  
Vasudevan Ramachandran ◽  
Zalilah Mohd Shariff ◽  
Yit Siew Chin ◽  
...  

Background: Evidence is growing that a high-acid diet might accelerate the rate of bone loss, and gene polymorphisms such as Interleukin 6 (IL6) -174G/C and -572G/C are related to bone deterioration. However, no study of the interaction between diet and IL6 polymorphisms has been conducted among Asians. Thus, the objective of this study was to determine whether IL6 gene polymorphisms modified the association between dietary acidity and the rate of bone resorption. Methods: This cross-sectional study recruited 203 postmenopausal women (age ranged from 51 to 85 years old) in community settings. The dietary intakes of the participants were assessed using a validated interviewer-administered semi-quantitative food frequency questionnaire (FFQ), while dietary acid load (DAL) was estimated using net endogenous acid production (NEAP). Agena® MassARRAY genotyping analysis and serum collagen type 1 cross-linked C-telopeptide (CTX1) were used to identify the IL6 genotype and as a bone resorption marker, respectively. The interactions between diet and single-nucleotide polymorphisms (SNPs) were assessed using linear regressions. Results: A total of 203 healthy postmenopausal women aged between 51 and 85 years participated in this study. The mean BMI of the participants was 24.3 kg/m2. In IL6 -174 G/C, all the participants carried the GG genotype, while the C allele was absent. Approximately 40% of the participants had a high dietary acid load. Dietary acid load (B = 0.15, p = 0.031) and the IL6 -572 CC genotype group (B = 0.14, p = 0.044) were positively associated with a higher bone resorption. However, there was no moderating effect of the IL6 genetic polymorphism on the relationship between and acid ash diet and bone resorption markers among the postmenopausal women (p = 0.79). Conclusion: High consumption of an acid ash diet and the IL6 -572 C allele seem to attribute to high bone resorption among postmenopausal women. However, our finding does not support the interaction effect of dietary acidity and IL6 (-174G/C and -572G/C) polymorphisms on the rate of bone resorption. Taken together, these results have given scientific research other candidate genes to focus on which may interact with DAL on bone resorption, to enhance planning for preventing or delaying the onset of osteoporosis among postmenopausal women.


1996 ◽  
Vol 42 (10) ◽  
pp. 1639-1644 ◽  
Author(s):  
M Bonde ◽  
C Fledelius ◽  
P Qvist ◽  
C Christiansen

Abstract We present a coated-tube RIA that is useful for assessment of bone resorption. The assay uses a monoclonal antibody raised against a linear 8-amino-acid sequence (EKAHDGGR) derived from the C-telopeptides of type I collagen. Within-run and total CVs were 4.4% and 5.3-6.2%, respectively, at concentrations of 1-7 mg/L (n = 4-20). Analytical recovery was 98% +/- 8% and dilution 97% +/- 7%. Values obtained in a group of 36 premenopausal women were 227 +/- 89.6 mg/mol creatinine. In a group of 141 postmenopausal women, the values obtained were 429 +/- 225 mg/mol creatinine, a highly significant increase of 89% (P <0.001) over the premenopausal value. In a double-blind placebo-controlled clinical study of these postmenopausal women receiving five different doses of a bisphosphonate, a significant decrease of RIA-measured C-telopeptide values was seen in all bisphosphonate-treated groups, after just 3 months. Values in urine samples from postmenopausal women assayed with the RIA (gamma) and the CrossLaps(TM) ELISA (x) agreed well: slope = 0.98 (95% confidence interval, 0.94-1.01), intercept = 0.34 (0.25-0.43) mg/L, and Sylx = 0.93 mg/L (n = 678). We conclude that this RIA represents a valuable tool for assessing bone resorption.


2013 ◽  
Vol 98 (2) ◽  
pp. 571-580 ◽  
Author(s):  
Kim Brixen ◽  
Roland Chapurlat ◽  
Angela M. Cheung ◽  
Tony M. Keaveny ◽  
Thomas Fuerst ◽  
...  

Abstract Context: Odanacatib, a cathepsin K inhibitor, increases spine and hip areal bone mineral density (BMD) in postmenopausal women with low BMD and cortical thickness in ovariectomized monkeys. Objective: The objective of the study was to examine the impact of odanacatib on the trabecular and cortical bone compartments and estimated strength at the hip and spine. Design: This was a randomized, double-blind, 2-year trial. Setting: The study was conducted at a private or institutional practice. Participants: Participants included 214 postmenopausal women with low areal BMD. Intervention: The intervention included odanacatib 50 mg or placebo weekly. Main Outcome Measures: Changes in areal BMD by dual-energy x-ray absorptiometry (primary end point, 1 year areal BMD change at lumbar spine), bone turnover markers, volumetric BMD by quantitative computed tomography (QCT), and bone strength estimated by finite element analysis were measured. Results: Year 1 lumbar spine areal BMD percent change from baseline was 3.5% greater with odanacatib than placebo (P < .001). Bone-resorption marker C-telopeptide of type 1 collagen was significantly lower with odanacatib vs placebo at 6 months and 2 years (P < .001). Bone-formation marker procollagen I N-terminal peptide initially decreased with odanacatib but by 2 years did not differ from placebo. After 6 months, odanacatib-treated women had greater increases in trabecular volumetric BMD and estimated compressive strength at the spine and integral and trabecular volumetric BMD and estimated strength at the hip (P < .001). At the cortical envelope of the femoral neck, bone mineral content, thickness, volume, and cross-sectional area also increased from baseline with odanacatib vs placebo (P < .001 at 24 months). Adverse experiences were similar between groups. Conclusions: Over 2 years, odanacatib decreased bone resorption, maintained bone formation, increased areal and volumetric BMD, and increased estimated bone strength at both the hip and spine.


2015 ◽  
Vol 21 (12) ◽  
pp. 1380-1386 ◽  
Author(s):  
Naina Sinha Gregory ◽  
Rekha Kumar ◽  
Emily M. Stein ◽  
Ellen Alexander ◽  
Paul Christos ◽  
...  

2005 ◽  
Vol 32 (6) ◽  
pp. 738-745 ◽  
Author(s):  
Julie A. Pasco ◽  
Margaret J. Henry ◽  
Geoffrey C. Nicholson ◽  
Hans G. Schneider ◽  
Mark A. Kotowicz

2020 ◽  
Vol 32 (4) ◽  
pp. 705-712
Author(s):  
G. Gayathri ◽  
AJ Hemamalini

Background: Indigenous plant based dietary supplement that is accessible and safer may help to combat the more proclaimed calcium deficiency among Indian population and improve bone strength. Aim & Objective: To formulate an indigenous calcium rich food supplement and study its impact on markers of bone resorption and formation. Settings and Design: Sixty subjects (80% power, α = 0.05) including 30 perimenopausal and postmenopausal women each were randomly assigned to control and experimental groups. Methods and Material: Experimental postmenopausal and perimenopausal women received 1200mg and 800mg per day of calcium respectively from a plant based supplement comprising Sesamum indicum, Eleusine coracana, Glycine max Vigna mungo and Sesbania grandiflora as a midmorning and evening snack. Measures like serum calcium, betacrosslaps (bone resorption marker), total P1NP (bone formation marker) were assessed at baseline, 3rd and 6th month. Results: Fifty-seven subjects were analysed with no adverse events were reported. Results showed that after supplementation betacrosslaps reduced from 0.32±0.130 ng/ml to 0.25±0.130 ng/ml and 1.11±0.290 ng/ml to 0.42±0.263 ng/ml in perimenopausal and postmenopausal subjects significant at (P=0.008) and (P=0.012) respectively. Conclusions: Adequate dietary calcium intake using locally available foods is recommended as a strategic option in reducing risk of osteoporosis.


2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1748-1748
Author(s):  
Roberto Burini ◽  
Loraine Gollino ◽  
Rafael Lima ◽  
Hugo Kano ◽  
Adriana Mendes ◽  
...  

Abstract Objectives To evaluate the additional effect of whey protein supplementation (WPS) to the physical-exercise training on bone resorption in postmenopausal women. Methods In a prospective, controlled study, 38 postmenopausal women aged 50 to 70 years, were randomized into two groups: with WPS (n = 19) and without WPS (n = 19, control) intervention. The study included amenorrheic women (above 12 months) with normal bone mineral density (T-score ≥ −1.0 SD) not taken bone-related medicines, and practitioners of a physical exercise protocol involving combined walking/jogging and academy/resistance exercises performed under professional supervising, three times a week. Together, there was a weekly dietary counseling along with a daily supplementation of either 25 g of protein (WPS) or placebo. Food intake (24-hour recall), anthropometric, general biochemistry, plasma hormones and bone resorption marker: serum C-terminal cross-linked N-telopeptides of type-I collagen (s-CTX) assessments were undertaken at baseline and after 20-wk intervention. Statistical analysis of the data (P < 0.05) was performed by using a time-repeated measures (ANOVA) followed by the Tukey multiple comparison test adjusted for group x moment interaction, or by gamma distribution (asymmetric variables). Results The groups were anthropometric and biochemical homogeneous, at baseline and after the intervention. Both groups increased similarly the intake of energy and lipids. However, only WPS significantly increased the intake of protein, calcium, phosphates and magnesium, as well as leucine, isoleucine and valine. From a similar baseline plasma values of s-CTX, calcium, phosphorus, alkaline phosphatase and parathormone, only s-CTX responded significantly to the intervention, being reduced in both groups (-34% and −15.2%), statistically significant in the control(non-WPS) group (P = 0.016). Conclusions The reduced plasma marker of bone resorption marker was observed in post-menopause women submitted to a 20-wk lifestyle-modification protocol with physical exercises, independently to the whey protein supplementation. Clinical trial (REBEC): RBR-7KD97. Funding Sources Brazilian foundations CNPq and CAPES.


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