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. Description: 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属文件阐明了本研究中收集的各类数据范畴，并制定了当前及未来该数据的管理政策。

炎症是维持机体健康与诸多修复过程的核心基础。但若炎症未能得到有效缓解，则会引发严重的健康问题。未被控制的炎症在多种慢性疾病中发挥关键作用，例如心血管疾病（CVD）、类风湿关节炎等自身免疫性疾病，以及糖尿病与其他代谢相关疾病。因此，调控炎症反应的能力是维持机体健康状态的核心要素。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正日益受到关注，且极具应用前景，旨在提升慢性疾病患者的健康水平。

Omega-3补充剂已被证实可显著降低炎症生物标志物水平。本临床试验基于现有科学研究成果——即Omega-3补充剂在改善炎症状态中的作用——展开。

本研究为一项随机、安慰剂对照临床试验，旨在探究一款新型富含Omega-3的食品对跟腱炎（Achilles tendinopathy）患者炎症标志物的影响。本研究将从奥克兰地区各物理治疗诊所招募60名慢性跟腱炎患者作为受试者。受试者将被随机分为治疗组与对照组（每组30人）。干预开始前，所有受试者需完成以下流程：采集血液样本以分析循环炎症因子，以此探究全身炎症状态；填写跟腱炎严重程度自评问卷；接受超声弹性成像检查以评估跟腱的症状、结构与功能；同时填写情绪与健康相关问卷。

随后两组受试者将分别服用指定食品：治疗组食品含有源自藻类与NZ Hoki油的活性Omega-3成分，对照组食品则采用不含Omega-3的植物源性油脂。受试者需每日服用9克该食品，持续12周；其中治疗组每份食品的Omega-3含量约为2.5克。

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。

综上，本临床试验有望证实富含Omega-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。