What Is Nattokinase? Other Names: BSP, Extrait de Natto, Fermented Soybeans

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What is Nattokinase?

Nattokinase (NK) is a potent enzyme derived from the traditional Japanese food natto, which is fermented soybeans. This enzyme has garnered significant attention due to its various health benefits, particularly its fibrinolytic (blood clot-dissolving) activity. Produced by the bacterium Bacillus subtilis during the fermentation process, nattokinase has been extensively studied for its potential applications in treating cardiovascular diseases, hypertension, and other health conditions. Other names include: BSP, Extrait de Natto, Fermented Soybeans, Haricots de Soja Fermentés, Natto de Soja, Natto Extract, Nattokinasa, NK, Soy Natto, Subtilisin NAT.

Production and Characteristics

Nattokinase is an extracellular enzyme produced by Bacillus subtilis natto. It is classified as a serine protease with the enzyme commission number EC 3.4.21.62. The enzyme is known for its stability in the gastrointestinal tract, making it suitable for oral administration1. The production of nattokinase involves microbial fermentation, and the enzyme can be purified using various chromatographic techniques2. The molecular weight of nattokinase is approximately 27,728 Daltons, and it consists of 275 amino acid residues2.

Biological Activity and Therapeutic Applications

Nattokinase exhibits strong fibrinolytic activity, which makes it a valuable agent for thrombolytic therapy. It has been shown to digest fibrin, a protein involved in blood clot formation, and several synthetic substrates2. This enzyme has been studied for its potential in treating cardiovascular diseases, including deep vein thrombosis, phlebitis, and venous insufficiency7. Additionally, nattokinase has demonstrated antihypertensive, anti-atherosclerotic, lipid-lowering, antiplatelet, and neuroprotective effects9.

Safety and Toxicological Assessment

The safety of nattokinase has been evaluated in various studies. It has been found to be non-mutagenic and non-clastogenic in vitro, with no adverse effects observed in subchronic toxicity studies conducted in rodents4. Human trials have also shown that nattokinase is well-tolerated, with no significant adverse effects reported4 7. These findings suggest that nattokinase is a safe dietary supplement for human consumption.

Challenges and Future Prospects

Despite its promising therapeutic potential, the production and preservation of nattokinase present several challenges. Issues such as unstable yield and enzyme activity loss during production need to be addressed. Potential solutions include the heterologous expression of the nattokinase gene, optimization of microbial fermentation strategies, and innovative purification methods3. Additionally, encapsulation and immobilization techniques can enhance the stability and protection of nattokinase, ensuring its sustainability across various applications3.

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Adverse Effects of Nattokinase

General Safety and Toxicity

Nattokinase was found to be non-mutagenic and non-clastogenic in vitro, and no adverse effects were observed in 28-day and 90-day subchronic toxicity studies in rats at high doses2.

Human studies also indicated that consumption of nattokinase at 10 mg/kg-day for 4 weeks was well tolerated with no significant adverse effects2.

Hemorrhagic Risk

Nattokinase caused pulmonary hemorrhage at very high doses (300 mg/kg) in animal studies, indicating a potential risk of bleeding at high concentrations3.

Compared to tissue-type plasminogen activator (t-PA), nattokinase had a relatively lower hemorrhagic risk, with a standard safety margin (SSM) of 4.0, which was improved to 8.0 with dexamethasone co-treatment3.

Effects on Hemostatic Factors

Nattokinase supplementation was associated with prolonged collagen-epinephrine closure time (C-EPI CT), prothrombin time (PT), and activated partial thromboplastin time (aPTT) in hypercholesterolemic subjects, indicating an effect on blood clotting parameters4.

No Significant Adverse Events in Clinical Trials

Clinical trials reported no notable adverse events due to nattokinase intake, suggesting it is generally safe for human consumption at recommended doses1.

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How has Nattokinase Improved Patient Outcomes?

Cardiovascular Health and Blood Pressure

Nattokinase has been shown to reduce both systolic and diastolic blood pressure in hypertensive patients, with more significant effects observed in males4. It also lowers von Willebrand factor, a cardiovascular risk marker4.

NK effectively manages atherosclerosis and hyperlipidemia, significantly improving lipid profiles and reducing carotid artery plaque size at higher doses (10,800 FU/day)6.

Thrombolytic and Fibrinolytic Activity

Nattokinase improves clinical symptoms in patients with vascular diseases such as deep vein thrombosis and venous insufficiency without adverse reactions1.

It prolongs clotting times (C-EPI CT, PT, aPTT) in hypercholesterolemic subjects, indicating enhanced fibrinolytic activity2.

NK reduces infarction volume and improves cerebral blood flow in ischemic stroke models by inhibiting platelet aggregation and thrombus formation5.

Cancer Treatment

Intratumoral injection of nattokinase degrades extracellular matrix components, reduces tumor stiffness, and enhances the efficacy of chemotherapy, radiotherapy, and CAR-T cell therapy in solid tumors3.

Neuroprotection and Cognitive Recovery

Nattokinase promotes neurogenesis and cognitive recovery post-stroke by increasing circulating irisin levels, which supports brain regeneration9.

Safety and Delivery

NK is safe and well-tolerated at higher doses, with no significant adverse effects reported1 6.

Encapsulation techniques improve the stability and bioavailability of nattokinase, enhancing its thrombolytic effects and targeting capabilities8.

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Nattokinase Mechanisms of Action

Direct Thrombolytic Activity

Nattokinase directly dissolves fibrin, the primary protein involved in blood clot formation, by breaking down fibrin networks1 4 8.

Stimulation of t-PA Production

NK stimulates the production of tissue plasminogen activator (t-PA), which is crucial for converting plasminogen to plasmin, an enzyme that degrades fibrin clots1.

Inhibition of Platelet Aggregation

NK inhibits platelet aggregation, which is a critical step in the formation of blood clots, thereby reducing the risk of thrombosis1 5.

Reduction of Oxidative Stress

NK reduces oxidative damage by decreasing levels of reactive oxygen species (ROS) such as superoxide anion (O2-) and hydroxyl radical (·OH), which are known to contribute to thrombosis1 7.

Hydrolysis of Thrombin

NK hydrolyzes thrombin, a key enzyme in the coagulation cascade, thereby disrupting the cycle of inflammation, oxidative stress, and thrombosis7.

Antihypertensive Effects

NK exhibits antihypertensive effects by reducing plasma fibrinogen levels and potentially influencing the renin-angiotensin system, although its fragments may act through different mechanisms6.

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