代谢综合征患者补充麦角硫因（ErgMS）：一项随机、双盲、安慰剂对照试验研究方案
Ergothioneine supplementation in people with metabolic syndrome (ErgMS): protocol for a randomised, double-blind, placebo-controlled pilot study.
作者信息
Tian Xiaoying, Cioccoloni Giorgia, Sier Joanna H, Naseem Khalid M, Thorne James L, Moore J Bernadette
机构信息
School of Food Science & Nutrition, University of Leeds, Leeds, LS2 9JT, UK.
Leeds Institute of Cardiovascular & Metabolic Medicine, University of Leeds, Leeds, LS2 9JT, UK.
出版信息
Pilot Feasibility Stud. 2021 Oct 29;7(1):193. doi: 10.1186/s40814-021-00929-6.
BACKGROUND
Ergothioneine is a naturally occurring metabolite of histidine found in many foods and in high amounts in mushrooms. In vivo, ergothioneine acts as an antioxidant and is widely distributed in most mammalian tissues. While ergothioneine is sold as a dietary supplement for its antioxidant and anti-inflammatory properties, to date there are no published intervention trials examining its health benefits in humans. The aim of this work was to develop a study protocol for a pilot interventional trial that will establish the primary and secondary outcomes, and the power required, for a definitive randomised controlled trial to test the hypothesis that ergothioneine supplementation is beneficial for people with metabolic syndrome.
METHODS
We have designed the ErgMS study as a single-centre, randomised, double-blind, placebo-controlled, 3-arm parallel, pilot intervention trial, which aims to supplement participants with either placebo, 5 or 30 mg/day ergothioneine for 12 weeks. Measurements of metabolic syndrome risk factors, serum markers of oxidative stress (lipid peroxidation), inflammation, blood platelet function and liver function will take place at baseline, and after 6 weeks and 12 weeks of supplementation. In addition, we will examine if there are any changes in the serum metabolome in response to ergothioneine supplementation. Linear regression and two-way ANOVA will be utilised to analyse the association between ergothioneine and measured variables.
DISCUSSION
The ErgMS study will be the first study to address the question does ergothioneine supplementation have health benefits for people with metabolic syndrome. Study results will provide preliminary data as to which dose may improve inflammatory markers in adults with metabolic syndrome and will inform dose and primary outcome selection for a definitive randomised controlled trial.
TRIAL REGISTRATION
ISRCTN, ISRCTN25890011 Registered February 10, 2021.
背景
麦角硫因是组氨酸的一种天然代谢产物，存在于许多食物中，在蘑菇中的含量很高。在体内，麦角硫因作为一种抗氧化剂，广泛分布于大多数哺乳动物组织中。虽然麦角硫因因其抗氧化和抗炎特性作为膳食补充剂出售，但迄今为止，尚无已发表的干预试验研究其对人类健康的益处。这项工作的目的是制定一项初步干预试验的研究方案，该试验将确定主要和次要结果以及所需的样本量，以便进行一项确定性随机对照试验，以检验补充麦角硫因对代谢综合征患者有益的假设。
方法
我们将ErgMS研究设计为一项单中心、随机、双盲、安慰剂对照、三臂平行的初步干预试验，旨在为参与者补充安慰剂、5毫克/天或30毫克/天的麦角硫因，为期12周。将在基线时以及补充6周和12周后测量代谢综合征风险因素、氧化应激（脂质过氧化）、炎症、血小板功能和肝功能的血清标志物。此外，我们将研究补充麦角硫因后血清代谢组是否有任何变化。将利用线性回归和双向方差分析来分析麦角硫因与测量变量之间的关联。
讨论
ErgMS研究将是第一项解决补充麦角硫因对代谢综合征患者是否有益这一问题的研究。研究结果将提供关于哪种剂量可能改善代谢综合征成年人炎症标志物的初步数据，并为确定性随机对照试验的剂量和主要结果选择提供信息。
试验注册
ISRCTN，ISRCTN25890011。于2021年2月10日注册。
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