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. Description: 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.

本元数据记录及其所附文件对作为本研究一部分收集的数据类型作出声明，并制定了该数据现在及未来治理的政策。描述如下：旨在评估每日摄入26周闪蒸全壳贻贝肉粉（每日3克）对老年（60-74岁）健康成人早期骨关节炎迹象或症状的联合保护作用。此目标将通过监测软骨降解和合成标志物的变化来实现，包括II型前胶原（CP-II）、II型胶原蛋白C端延伸肽（CTX-II）和软骨寡聚基质蛋白（COMP）；炎症标志物的变化，包括细胞因子IL-1α、IL-1β、IL-18和TNF-α；患者报告结果指标（PROMs）的变化，包括膝关节损伤和骨关节炎评分（KOOS）、间歇性和持续性疼痛测量（ICOAP）以及疼痛视觉模拟评分（VAS）；最后，通过OARSI身体功能评估测试测量的表现结果指标的变化，包括30秒坐立测试、爬楼梯测试和40米快速行走测试。次要目标是研究饮食的炎症潜力、炎症和软骨生物标志物、PROMs以及具有早期骨关节炎迹象和症状者的表现结果指标之间的关联。