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.

本元数据记录及其附加文件阐述了本研究收集的数据类型，并制定了该数据当前及未来的治理政策。<b>描述：</b>炎症是维持健康及多种愈合过程的基础。然而，未解决的炎症会带来严重的健康后果。未解决的炎症在多种慢性疾病中起关键作用，例如心血管疾病（CVD）、类风湿关节炎等自身免疫性疾病，以及糖尿病和其他代谢相关疾病。因此，调节炎症过程的能力是维持健康状况的基础。基于此，以治疗性靶向全身炎症来改善健康结局的理念是一个不断发展且前景广阔的研究领域，旨在改善慢性健康障碍患者的健康状况。补充Omega-3对降低炎症生物标志物具有可验证的效果。本试验基于现有科学文献，这些文献表明Omega-3补充剂在改善炎症方面的作用。这是一项随机、安慰剂对照临床试验，旨在探索新型高Omega-3食品对跟腱病患者炎症标志物的影响。将从奥克兰地区各物理治疗诊所招募60名慢性跟腱病患者。参与者将被随机分为治疗组和对照组（每组30人），干预前将采集血样分析循环炎症细胞因子以研究全身炎症，完成跟腱病严重程度自评问卷，并接受弹性成像超声检查以评估跟腱的症状、结构和功能，同时完成情绪与健康状况相关问卷。每组参与者将获得一种食品，治疗组食品含有源自藻类油和新西兰蓝鳕鱼（Hoki）油的活性Omega-3成分，安慰剂组食品含有不含Omega-3的植物源油。参与者将连续12周每天食用9克该食品，治疗组每份食品约含2.5克Omega-3。6周后及研究结束时（12周），将重新评估所有结局指标。总体而言，本试验有望证明高Omega-3食品在缓解全身炎症、改善肌肉骨骼结局及提升健康状况方面的作用。