HVN 1912 Metadata Record - Researching the role of Greenshell mussels and selected lifestyle and nutritional factors in participants with early signs and symptoms of knee osteoarthritis (The ROAM Study)

This metadata record and it's attached files make statements about the kinds of data collected as part of this research, and set out policies for governance of that data, now and in the future. <b>Description: </b>To evaluate the joint­-sparing effects of 26 weeks of daily intake of flash­dried powder from whole Greenshell mussel meat (3 gram per day), in older (60-74yrs) healthy adults with early signs or symptoms of osteoarthritis. This will be achieved by monitoring changes in cartilage markers of degradation and synthesis: including type II procollagen (CP­II), C­-telopeptide of type II collagen (CTX­II) and cartilage oligomeric matrix protein (COMP); changes in inflammatory markers: including cytokines IL-1a, IL-1ß, IL-18 and TNF-a; changes in patient reported outcome measures (PROMs): including the Knee Injury and Osteoarthritis Score (KOOS), Measure of Intermittent and Constant Pain (ICOAP) and Visual Analog Scale for Pain (VAS) and lastly changes in performance outcome measures measured by the OARSI physical function assessment tests: 30 second chair stand test, stair climb test and 40m fast paced walk test.The secondary objective is to look at the association between the inflammatory potential of the diet, inflammatory and cartilage biomarkers, PROMS and performance outcome measures for those with early signs and symptoms of osteoarthritis.

本元数据记录及其附属文件阐明了本研究采集的数据类型，并制定了该数据当前及未来的管理政策。**描述：** 本研究旨在评估每日摄入全绿唇贻贝肉（whole Greenshell mussel meat）闪干粉末（每日3克）、持续26周对60至74岁患有骨关节炎（osteoarthritis）早期症状与体征的健康老年人群的关节保护效应。本研究将通过监测以下指标变化达成该评估目标：软骨降解与合成标志物，包括Ⅱ型前胶原（type II procollagen, CP-II）、Ⅱ型胶原C端肽（C-telopeptide of type II collagen, CTX-II）及软骨寡聚基质蛋白（cartilage oligomeric matrix protein, COMP）；炎症标志物，包括细胞因子（cytokines）IL-1α、IL-1β、IL-18及TNF-α；患者报告结局量表（patient reported outcome measures, PROMs），包括膝关节损伤与骨关节炎评分（Knee Injury and Osteoarthritis Score, KOOS）、间歇性与持续性疼痛量表（Measure of Intermittent and Constant Pain, ICOAP）及疼痛视觉模拟评分（Visual Analog Scale for Pain, VAS）；最后通过国际骨关节炎研究学会（Osteoarthritis Research Society International, OARSI）制定的体能评估测试采集体能结局指标变化，具体包括30秒坐站试验、爬梯试验及40米快走试验。本研究的次要目标为，探究骨关节炎早期症状与体征人群的饮食炎症潜力、炎症与软骨生物标志物、患者报告结局量表及体能结局指标之间的关联。