口服从芥末中提取的6-甲基亚磺酰基己基异硫氰酸酯是安全的，并且能改善健康志愿者的疲劳和睡眠状况。
Oral administration of 6-methylsulfinylhexyl isothiocyanate extracted from wasabi is safe and improves the fatigue and sleep of healthy volunteers.
作者信息
Nakajima Ryota, Kanou Masanobu, Tokushima Masahiko, Iwama Yoshitaka, Yamana Kei
机构信息
Nutraceutical Group, Division of New Business in Healthcare Business, Teijin Ltd., 2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo, 100-8585, Japan.
NOMON Co., Ltd, Tokyo, Japan.
出版信息
Biopsychosoc Med. 2023 Aug 23;17(1):30. doi: 10.1186/s13030-023-00287-0.
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.
背景
本研究旨在对山葵根茎中含有的6-甲基亚磺酰基己基异硫氰酸酯（6-MSITC）对疲劳和睡眠的影响进行初步评估，并通过过量研究考察其安全性。
方法
共有20名日常感到疲劳的健康志愿者服用了从山葵中提取的含有6-MSITC的粉末（6-MSITC剂量为4.8毫克/天），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，采用双盲、安慰剂对照方法，对30名健康志愿者进行了提取物粉末的过量安全性研究（6-MSITC剂量高达16毫克/天，持续4周）。
结果
含有6-MSITC的粉末在脑力任务后并未改善疲劳，但在摄入4周后，脑力任务前的疲劳、睡眠和情绪均有显著改善。自主神经功能、压力或免疫指标未见变化。在过量安全性研究中，未观察到参数变化或副作用，结果表明高剂量的含6-MSITC提取物粉末是安全的。
结论
本研究证实了从山葵中提取的含有6-MSITC的这种粉末可能改善疲劳和睡眠的可能性。然而，由于本研究中的有效性评估是单臂、开放标签研究，且没有安慰剂对照组，在解释结果时必须考虑这些因素。在过量研究中确认的安全剂量是功效评估研究中剂量的三倍以上。未来，应进一步研究其对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。2022年12月27日追溯注册，https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000056818。
Zotero 插件