Effective management of atherosclerosis progress and hyperlipidemia with nattokinase: A clinical study with 1,062 participants

Nattokinase (NK), known as a potent fibrinolytic and antithrombotic agent, has been shown to have antiatherosclerotic and lipid-lowering effects. However, data on human clinical studies are limited. In this clinical study involving 1,062 participants, our objective was to examine the efficacy of NK...

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Main Authors: Hongjie Chen, Jiepeng Chen, Fuping Zhang, Yuanhui Li, Ronghua Wang, Qiang Zheng, Xu Zhang, Jun Zeng, Feng Xu, Yiguang Lin
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-08-01
Series:Frontiers in Cardiovascular Medicine
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fcvm.2022.964977/full
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author Hongjie Chen
Jiepeng Chen
Fuping Zhang
Yuanhui Li
Ronghua Wang
Qiang Zheng
Xu Zhang
Jun Zeng
Feng Xu
Yiguang Lin
Yiguang Lin
Yiguang Lin
author_facet Hongjie Chen
Jiepeng Chen
Fuping Zhang
Yuanhui Li
Ronghua Wang
Qiang Zheng
Xu Zhang
Jun Zeng
Feng Xu
Yiguang Lin
Yiguang Lin
Yiguang Lin
author_sort Hongjie Chen
collection DOAJ
description Nattokinase (NK), known as a potent fibrinolytic and antithrombotic agent, has been shown to have antiatherosclerotic and lipid-lowering effects. However, data on human clinical studies are limited. In this clinical study involving 1,062 participants, our objective was to examine the efficacy of NK in atherosclerosis and hyperlipidemia and safety at the dose of 10,800 FU/day after 12 months of oral administration. Various factors, including lower doses that influence NK pharmacological actions, were also investigated. We found that NK at a dose of 10,800 FU/day effectively managed the progression of atherosclerosis and hyperlipidemia with a significant improvement in the lipid profile. A significant reduction in the thickness of the carotid artery intima-media and the size of the carotid plaque was observed. The improvement rates ranged from 66.5 to 95.4%. NK was found to be ineffective in lowering lipids and suppressing atherosclerosis progression at a dose of 3,600 FU/day. The lipid-lowering effect of NK was more prominent in subjects who smoked, drank alcohol, and subjects with higher BMI. Regular exercise further improved the effects of NK. Co-administration of vitamin K2 and aspirin with NK produced a synergetic effect. No noticeable adverse effects associated with the use of NK were recorded. In conclusion, our data demonstrate that atherosclerosis progression and hyperlipidemia can be effectively managed with NK at a dose of 10,800 FU/day. The lower dose of 3,600 FU per day is ineffective. The dose of 10,800 FU/day is safe and well tolerated. Some lifestyle factors and the coadministration of vitamin K2 and aspirin lead to improved outcomes in the use of NK. Our findings provide clinical evidence on the effective dose of NK in the management of cardiovascular disease and challenge the recommended dose of 2,000 FU per day.
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spelling doaj.art-b316ca36d630474d930757fa45a8924b2022-12-22T04:38:00ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-08-01910.3389/fcvm.2022.964977964977Effective management of atherosclerosis progress and hyperlipidemia with nattokinase: A clinical study with 1,062 participantsHongjie Chen0Jiepeng Chen1Fuping Zhang2Yuanhui Li3Ronghua Wang4Qiang Zheng5Xu Zhang6Jun Zeng7Feng Xu8Yiguang Lin9Yiguang Lin10Yiguang Lin11Department of Traditional Chinese Medicine, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, ChinaSungen Bioscience Co. Ltd., Shantou, ChinaDepartment of Pharmacy, Shenyang Red Cross Hospital, Shenyang, ChinaGuangzhou Center, Sinopharm Group Pharmaceutical Co., Ltd., Guangzhou, ChinaSungen Bioscience Co. Ltd., Shantou, ChinaSungen Bioscience Co. Ltd., Shantou, ChinaSungen Bioscience Co. Ltd., Shantou, ChinaSungen Bioscience Co. Ltd., Shantou, ChinaAntithrombotic & Thrombolytic Innovative Drug Research Center, Shenyang Pharmaceutical University, Shenyang, ChinaDepartment of Traditional Chinese Medicine, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, ChinaThe Central Laboratory, First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, ChinaSchool of Life Sciences, University of Technology Sydney, Sydney, NSW, AustraliaNattokinase (NK), known as a potent fibrinolytic and antithrombotic agent, has been shown to have antiatherosclerotic and lipid-lowering effects. However, data on human clinical studies are limited. In this clinical study involving 1,062 participants, our objective was to examine the efficacy of NK in atherosclerosis and hyperlipidemia and safety at the dose of 10,800 FU/day after 12 months of oral administration. Various factors, including lower doses that influence NK pharmacological actions, were also investigated. We found that NK at a dose of 10,800 FU/day effectively managed the progression of atherosclerosis and hyperlipidemia with a significant improvement in the lipid profile. A significant reduction in the thickness of the carotid artery intima-media and the size of the carotid plaque was observed. The improvement rates ranged from 66.5 to 95.4%. NK was found to be ineffective in lowering lipids and suppressing atherosclerosis progression at a dose of 3,600 FU/day. The lipid-lowering effect of NK was more prominent in subjects who smoked, drank alcohol, and subjects with higher BMI. Regular exercise further improved the effects of NK. Co-administration of vitamin K2 and aspirin with NK produced a synergetic effect. No noticeable adverse effects associated with the use of NK were recorded. In conclusion, our data demonstrate that atherosclerosis progression and hyperlipidemia can be effectively managed with NK at a dose of 10,800 FU/day. The lower dose of 3,600 FU per day is ineffective. The dose of 10,800 FU/day is safe and well tolerated. Some lifestyle factors and the coadministration of vitamin K2 and aspirin lead to improved outcomes in the use of NK. Our findings provide clinical evidence on the effective dose of NK in the management of cardiovascular disease and challenge the recommended dose of 2,000 FU per day.https://www.frontiersin.org/articles/10.3389/fcvm.2022.964977/fullnattokinaseatherosclerosishyperlipidaemiaanti-atherogenic druglipid lowering effectretrospective study
spellingShingle Hongjie Chen
Jiepeng Chen
Fuping Zhang
Yuanhui Li
Ronghua Wang
Qiang Zheng
Xu Zhang
Jun Zeng
Feng Xu
Yiguang Lin
Yiguang Lin
Yiguang Lin
Effective management of atherosclerosis progress and hyperlipidemia with nattokinase: A clinical study with 1,062 participants
Frontiers in Cardiovascular Medicine
nattokinase
atherosclerosis
hyperlipidaemia
anti-atherogenic drug
lipid lowering effect
retrospective study
title Effective management of atherosclerosis progress and hyperlipidemia with nattokinase: A clinical study with 1,062 participants
title_full Effective management of atherosclerosis progress and hyperlipidemia with nattokinase: A clinical study with 1,062 participants
title_fullStr Effective management of atherosclerosis progress and hyperlipidemia with nattokinase: A clinical study with 1,062 participants
title_full_unstemmed Effective management of atherosclerosis progress and hyperlipidemia with nattokinase: A clinical study with 1,062 participants
title_short Effective management of atherosclerosis progress and hyperlipidemia with nattokinase: A clinical study with 1,062 participants
title_sort effective management of atherosclerosis progress and hyperlipidemia with nattokinase a clinical study with 1 062 participants
topic nattokinase
atherosclerosis
hyperlipidaemia
anti-atherogenic drug
lipid lowering effect
retrospective study
url https://www.frontiersin.org/articles/10.3389/fcvm.2022.964977/full
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