Tay Audrey, Jiang Yannan, Signal Nada, O'Brien Daniel, Chen Jinsong, Murphy Rinki, Lu Jun
Faculty of Medical and Health Sciences, School of Medicine, University of Auckland, Auckland, New Zealand.
Auckland Diabetes Centre, Auckland District Health Board, Auckland, New Zealand.
Front Nutr. 2022 Sep 21;9:1000510. doi: 10.3389/fnut.2022.1000510. eCollection 2022.
Pharmaceutical drugs are beneficial to inflammatory conditions but with side effects, which led to the search for alternative therapies. , the New Zealand green-lipped mussel, have shown promise in placebo-controlled trials for inflammatory conditions. Fucoidan, an extract from seaweed , has been found to have beneficial effects on joint pain and insulin resistance. However, green-lipped mussel and fucoidan have never been combined.
A parallel, two-arm, double-blind, randomized, placebo-controlled trial will be conducted in New Zealand to determine whether a food product supplemented with green-lipped mussel and fucoidan improves joint pain and/or insulin resistance. Those who are ethnically Chinese, are aged over 30 years, have prediabetes and hip or knee joint pain will be eligible to participate. They will be randomized at 1:1 ratio to consume either dark chocolate supplemented with 1000 mg mussel powder and 1000 mg fucoidan or dark chocolate with no active substances daily for 100 days. The primary endpoints are change in insulin resistance and patient-reported joint pain. Secondary endpoints include anthropometry, fasting glucose and insulin, HbA1c, inflammatory markers, satiety, quality of life, physical function, pain intensity, and analgesic medication use. A sample size of 150 (75 per arm) will provide 90% power at an overall significance level of 5% (two-sided) to detect a standardized effect size of 0.625 on either of the two co-primary outcomes allowing for 10% loss.
The study was approved by the Health and Disability Ethics Committee (number: 20/STH/153). Results will be made available to participants, funders, and other researchers.
This trial will provide data on the potential utility of a mussel-fucoidan supplement in reducing joint pain and/or insulin resistance, to inform the development of a supplemented food product suitable for the Chinese market.
https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12621000413820, ANZCTR Registration: ACTRN12621000413820, on 15 April 2021.
药物对炎症性疾病有益，但存在副作用，这促使人们寻找替代疗法。新西兰绿唇贻贝在炎症性疾病的安慰剂对照试验中显示出前景。岩藻依聚糖，一种从海藻中提取的物质，已被发现对关节疼痛和胰岛素抵抗有有益作用。然而，绿唇贻贝和岩藻依聚糖从未被联合使用过。
将在新西兰进行一项平行、双臂、双盲、随机、安慰剂对照试验，以确定一种添加了绿唇贻贝和岩藻依聚糖的食品是否能改善关节疼痛和/或胰岛素抵抗。符合条件的参与者需为华裔，年龄超过30岁，患有糖尿病前期且有髋关节或膝关节疼痛。他们将按1:1的比例随机分组，每天食用添加1000毫克贻贝粉和1000毫克岩藻依聚糖的黑巧克力或不含活性物质的黑巧克力，持续100天。主要终点是胰岛素抵抗的变化和患者报告的关节疼痛。次要终点包括人体测量学指标、空腹血糖和胰岛素、糖化血红蛋白、炎症标志物、饱腹感、生活质量、身体功能、疼痛强度和镇痛药使用情况。样本量为150例（每组75例）将在总体显著性水平为5%（双侧）时提供90%的检验效能，以检测两个共同主要结局中任一结局的标准化效应大小为0.625，同时考虑10%的失访率。
该研究已获得健康与残疾伦理委员会批准（编号：20/STH/153）。研究结果将提供给参与者、资助者和其他研究人员。
本试验将提供关于贻贝-岩藻依聚糖补充剂在减轻关节疼痛和/或胰岛素抵抗方面潜在效用的数据，为开发适合中国市场的补充食品提供参考。
