HVN1964 Metadata Record - A New Zealand origin, omega-3-rich food for reducing markers of inflammation

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>Inflammation is fundamental in maintaining health, and in many healing processes. However, unresolved inflammation has severe health consequences. Unresolved inflammation plays a key role in several chronic diseases, such as cardiovascular disease (CVD), auto-immune diseases such as rheumatoid arthritis, and diabetes and other metabolic-related diseases. Thus, the ability to regulate inflammatory processes is fundamental to maintaining wellbeing. Based on this, the concept of therapeutically targeting systemic inflammation to improve health outcomes is a growing and promising area of research, targeted to improve the wellbeing of people with chronic health disorders.Supplementation with omega-3 has demonstrable effects on lowering biomarkers of inflammation. This trial builds on existing scientific literature demonstrating a role for omega-3 supplementation in improving inflammation.This is a a randomised, placebo-controlled clinical trial to explore the effects of a novel, omega-3-rich food product on markers of inflammation in people with Achilles tendinopathy. Sixty participants will be recruited from physiotherapy clinics across the Auckland region who are presenting with chronic Achilles tendinopathy. Participants will be randomised into treatment and control groups (30/group), and prior to intervention will have blood samples taken for analysis of circulating inflammatory cytokines to study systemic inflammation, take a self-reported questionnaire of tendinopathy severity and undergo ultrasound with elastography to assess symptoms, structure and function of the Achilles tendon, and take questionnaires related to mood and wellbeing.Participants in each group will then receive a food product, with the treatment group product containing the active omega-3 ingredient derived from algal and NZ Hoki oil, and the placebo group product containing a vegetable-derived oil that contains no omega-3. Participants will consume 9g of the food product a day for 12 weeks, which will equate to ~2.5g omega-3/serve in the treatment group. After 6 weeks, and at the end of the study (12 weeks), all outcome measures will be re-assessed.Overall, this trial has the potential to demonstrate a role for omega-3 rich foods in alleviating systemic inflammation, improving musculoskeletal outcomes and improving wellbeing.

本元数据（metadata）记录及其附件阐述了本研究收集的各类数据，并制定了该数据当前及未来的治理政策。<b>研究描述：</b>炎症在维持健康与诸多修复过程中发挥着基础作用，但持续未消退的炎症会引发严重健康问题。持续未消退的炎症在多种慢性病中扮演关键角色，例如心血管疾病（cardiovascular disease, CVD）、类风湿关节炎（rheumatoid arthritis）等自身免疫疾病（auto-immune diseases），以及糖尿病和其他代谢相关疾病。因此，调控炎症过程是维持机体健康的核心。基于此，通过治疗性靶向调控全身炎症以改善健康结局的研究方向日益受到关注，旨在提升慢性健康障碍患者的健康水平。ω-3脂肪酸（omega-3）补充剂已被证实可显著降低炎症生物标志物水平。本试验基于现有科学文献中关于ω-3补充剂改善炎症状态的研究成果展开。本研究为一项随机安慰剂对照临床试验（randomised, placebo-controlled clinical trial），旨在探究一款新型富含ω-3的食品对跟腱炎（Achilles tendinopathy）患者炎症标志物的影响。研究将从奥克兰地区各物理治疗诊所招募60名慢性跟腱炎患者。受试者将被随机分为治疗组与对照组（每组30人），干预前将采集血样以分析循环炎症细胞因子（circulating inflammatory cytokines），从而评估全身炎症状态；填写跟腱炎严重程度自评问卷；接受超声弹性成像（ultrasound with elastography）检查以评估跟腱的症状、结构与功能；同时完成情绪与健康相关问卷。随后，两组受试者将分别服用对应食品：治疗组产品含有源自藻类和新西兰狭鳕鱼（NZ Hoki）油的活性ω-3成分，对照组产品则采用不含ω-3的植物源性油脂。受试者每日需服用9克该食品，持续12周，其中治疗组每份产品约含2.5克ω-3。在干预6周后及研究结束（12周）时，将对所有结局指标进行重新评估。总体而言，本试验有望证实富含ω-3的食品在缓解全身炎症、改善肌肉骨骼结局及提升健康水平方面的作用。