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KMID : 1039620170070020264
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Korean Journal of Family Practice
2017 Volume.7 No. 2 p.264 ~ p.270
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Efficacy and Safety of Ultra Nattokinase as a Fibrinolytic Agent: A Randomized, Double-Blind, Placebo-Controlled Study
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Kim Min-Hee
Kwon Kyung-Min
Kim Kyung-Soo
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Abstract
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Background: Natto is a traditional Japanese food prepared by fermentation of beans by Bacillus subtilis (natto bacteria). Recent studies have revealed that nattokinase from natto has fibrinolytic functions with a good safety profile. This study was designed to evaluate the safety and efficacy of Ultra Nattokinase to determine its suitability for application to Korean people.
Methods: Forty-three healthy participants aged 20-60 years were enrolled into the study after informed consent was obtained. Ultra Nattokinase (200 mg) and maltodextrin (200 mg) were used as the investigation product and placebo, respectively, and were orally administered at a dose of one tablet 3 times a day, after meals for 9 weeks. The following parameters were evaluated: fibrinogen, activated partial thromboplastin time (aPTT), fibrin degradation product (FDP), prothrombin time (PT), plasminogen activator inhibitor-1 (PAT-1), and bleeding time (BT). The direct and residual effects at different time points were measured to evaluate the efficacy, and the side effects including its occurrence and severity were evaluated to determine the safety of Ultra Nattokinase. For statistical analysis, the intent-to-treat (ITT) group was selected and unpaired t-test was used for one-tailed test at a 5% significance level.
Results: In the ITT group, the direct effect of nattokinase on FDP was statistically significant (P=0.0292). Nattokinase was not associated with any serious side effect.
Conclusion: Ultra Nattokinase can be safely used to Korean people according to our study. Further, it can be used as an adjuvant therapy or a health food for those at risk of vascular disease.
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KEYWORD
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Ultra Nattokinase, Fibrin Degradation Product, Fibrinolysis, Safety
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