Oral administration of 6-methylsulfinylhexyl isothiocyanate extracted from wasabi is safe and improves the fatigue and sleep of healthy volunteers.

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS ACS Applied Bio Materials Pub Date : 2023-08-23 DOI:10.1186/s13030-023-00287-0

Ryota Nakajima, Masanobu Kanou, Masahiko Tokushima, Yoshitaka Iwama, Kei Yamana

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Abstract

Background: This study aimed to conduct a preliminary evaluation of the effects of 6-methylsulfinylhexyl isothiocyanate (6-MSITC) contained in wasabi rhizomes on fatigue and sleep and to examine its safety through overdose study.

Methods: A total of 20 healthy volunteers who were experiencing daily fatigue were given powder containing 6-MSITC (4.8 mg/day of 6-MSITC) extracted from wasabi for 4 weeks. Then, fatigue, sleep, autonomic nervous functioning, stress, and immunity were evaluated. In addition, an overdose safety study of the extract powder (up to 16 mg/day of 6-MSITC for 4 weeks) was performed with 30 healthy volunteers in a double-blind, placebo-controlled method.

Results: The powder containing 6-MSITC did not improve fatigue after a mental task, but fatigue before the mental task, sleep, and mood were improved significantly after 4 weeks intake. No changes were observed in the autonomic nerve function, stress, or immune markers. In the overdose safety study, no changes in the parameters or side effects were observed, and the results showed that high doses of the extract powder containing 6-MSITC is safe.

Conclusion: This study confirmed the possibility that this powder extracted from wasabi that contains 6-MSITC might improve fatigue and sleep. However, because the effectiveness evaluation in this study was a single-arm, open-label study and there was no placebo control group, these points must be considered when interpreting the results. Safety was confirmed in an overdose study of more than three times the amount compared to that in the efficacy evaluation study. In the future, further research should be conducted on its effectiveness for treating fatigue and sleep problems.

Trial registration: UMIN clinical trial registration system, UMIN000049913. Registered 27 December 2022 Retrospectively registered, https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000056818.

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口服从山葵中提取的6-甲基亚砜基己基异硫氰酸酯是安全的，可以改善健康志愿者的疲劳和睡眠。

背景:本研究旨在初步评价山葵根茎中6-甲基亚砜基己基异硫氰酸酯(6-MSITC)对疲劳和睡眠的影响，并通过过量研究验证其安全性。方法:选取20名日常疲劳的健康志愿者，给予从山葵中提取的含有6-MSITC (4.8 mg/d)的粉末，持续4周。然后对疲劳、睡眠、自主神经功能、压力和免疫力进行评估。此外，30名健康志愿者采用双盲、安慰剂对照的方法，对提取物粉末(最多16 mg/天6-MSITC，持续4周)进行了过量安全性研究。结果:6-MSITC粉对脑力任务后疲劳无改善作用，但摄入4周后脑力任务前疲劳、睡眠、情绪均有显著改善。自主神经功能、应激或免疫标志物未见变化。在过量安全性研究中，没有观察到参数的变化和副作用，结果表明高剂量含有6-MSITC的提取物粉是安全的。结论:本研究证实了从山葵中提取的含有6-MSITC的粉末有改善疲劳和睡眠的可能性。然而，由于本研究的有效性评价是单臂、开放标签研究，并且没有安慰剂对照组，因此在解释结果时必须考虑这些要点。与功效评估研究相比，在一项剂量超过三倍的过量研究中，安全性得到了证实。在未来，应进一步研究其治疗疲劳和睡眠问题的有效性。试验注册:UMIN临床试验注册系统，UMIN000049913。注册日期:2022年12月27日追溯注册，https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000056818。

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