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富含 HEA 的菌丝体的安全性评估:一项随机临床试验。

Safety Assessment of HEA-Enriched Mycelium: A Randomized Clinical Trial.

作者信息

Tsai You-Shan, Hsu Jui-Hsia, Lin David Pei-Cheng, Chang Han-Hsin, Chang Wen-Jui, Chen Yen-Lien, Chen Chin-Chu

机构信息

Biotech Research Institute, Grape King Bio Ltd, Taoyuan City, Taiwan.

Department of Medical Laboratory Science and Biotechnology, Chung Shan Medical University, Taichung City, Taiwan.

出版信息

J Am Coll Nutr. 2021 Feb;40(2):127-132. doi: 10.1080/07315724.2020.1743211. Epub 2020 Jul 23.

DOI:10.1080/07315724.2020.1743211
PMID:32702252
Abstract

, a medicinal fungus, is assessed as having many functions: anti-cancer, anti-fatigue, anti-aging, immune-boosting, renal and liver protection. Since the industrial production of mycelium consistently manufactures bioactive compounds superior to wild fruiting bodies, there is a need to confirm the toxicity of liquid fermented mycelium. Studies showed the toxicity evaluation of mycelium in animal models, but safety reports in clinical studies are scarce. As such, a safety assessment of oral N6-(2-hydroxyethyl) adenosine (HEA-enriched) mycelium in humans is provided here. After 49 participants ingested granules of 1.05 g of freeze-dried mycelium once a day for 3 months, their blood samples were collected at the beginning and end of the experiment for analysis. There were no significant differences between the initial and final measurements in renal and liver function. Also, there was no influence on blood electrolytes as well as blood lipid levels. In clinical observation, there were also no side effects or adverse feelings mentioned by participants. These results suggested that HEA-enriched mycelium produced by liquid fermentation is safe and can be developed as a functional health food.

摘要

作为一种药用真菌,被评估具有多种功能:抗癌、抗疲劳、抗衰老、增强免疫力、保护肾脏和肝脏。由于菌丝体的工业化生产持续制造出优于野生子实体的生物活性化合物,因此有必要确认液体发酵菌丝体的毒性。研究显示了在动物模型中对菌丝体的毒性评估,但临床研究中的安全性报告却很稀少。因此,本文提供了对人类口服N6-(2-羟乙基)腺苷(富含HEA)菌丝体的安全性评估。49名参与者每天服用一次1.05克冻干菌丝体颗粒,持续3个月,在实验开始和结束时采集他们的血液样本进行分析。肾功能和肝功能的初始测量值与最终测量值之间没有显著差异。对血液电解质以及血脂水平也没有影响。在临床观察中,参与者也未提及任何副作用或不适感受。这些结果表明,液体发酵生产的富含HEA的菌丝体是安全的,可以开发为功能性健康食品。

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