Two studies showed no safety concerns for nattokinase regarding toxicity and genotoxicity.[1] Nattokinase is derived from natto made from fermented soybeans, a Japanese food.
The first was published in Regulatory Toxicology and Pharmacology in 2019. The authors are from Shenyang Pharmaceutical University and Sungen Biotech Company in China.
The study was part of the preclinical evaluation for using nattokinase in cardiovascular diseases. In a previous post, I presented the effects of nattokinase in preventing heart diseases – The Outstanding Vascular Effects and Dose of Nattokinase.
Before we go to the results, if you are going to buy nattokinase capsules (which are over the counter), you will see that most of the pills are dosed in 2,000 FU.
FU stands for Fibrin Units and is used for the enzyme nattokinase. The standard for nattokinase manufacturing is a potency of 2,000 FU per capsule. A typical dose is 2,000 FU or 100 mg once a day.
Going to the study results, the investigation found that the maximum daily tolerant dose of nattokinase in mice is up to 480,000 FU/kg, which is 1,000 times more compared to the recommended daily amount for humans.[1]
According to the US FDA, A 100-fold safety factor is the default in applying animal data to humans. It is intended to account for potential differences in the kinetics and dynamics of a test substance when chemical-specific data or models are unavailable.[3]
The Japan Nattokinase Association recommended dose for nattokinase is 2,000 FU/day.
In the genotoxicity studies, nattokinase showed no mutagenic activity as tested by the Ames test and in vivo micronucleus assay using mice bone marrow.[1]
The Ames test is used to test whether a given chemical can cause mutations in the DNA of the test organism.
A micronucleus test is another toxicological screening for potential carcinogens that act by causing genetic damage (genotoxic). It is recognized as one of the most successful and reliable assays for genotoxic carcinogens.
Lastly, the study showed nattokinase has no potential to cause chromosome aberrations in Chinese hamster mice cells.[1]
The authors conclude,
These results indicate that there is no safety concern for nattokinase in the present preclinical safety studies, supporting the safety of nattokinase as an agent for cardiovascular disease prevention.[1]
The second study was by NSF International, a product testing, inspection, and certification organization headquartered in Ann Arbor, Michigan. The study was published in Food and Chemical Toxicology.[2]
The study involved a rat 90-day oral study up to 1,000 mg/kg-day. No toxicity was found in the animals, even at 1000 mg/kg daily. [2]
Like in the first study, no genotoxicity, chromosomal aberrations, and toxicity were seen using nattokinase in rats.
Their study also showed that healthy humans could tolerate 10 mg/kg per day of nattokinase for four weeks.[2]
In a 70 kg person, that would be 700 mg daily. Seven times more than the current recommended dose of 100 mg daily.
The margin of safety of nattokinase in the study is 140. For example, if a 60 kg person takes 110 mg of nattokinase, that is 1.8 mg/kg. [2]
A margin of safety corresponds to 250 mg/kg (140 x 1.8 mg/kg).[2]
Note: It is frustrating that the two studies used different units, one in FU and the other in milligrams. The other thing is that the second one used NSK-SD, the nattokinase formulation, with the vitamin K2 removed.
Summary
Despite the differences, the two studies show that nattokinase has a high safety margin with no evidence of harming DNA and chromosomes.
The current dose of 2,000 FU/day has a high safety margin.
I posted these studies because the next article concerns using nattokinase for atherosclerosis, which requires 10,800 FU daily.
Addendum: April 14, 2023. Nattokinase may be safe, but some may have a reaction to natto, the fermented soybean that is the source of nattokinase.
Natto may cause migraine with aura and blood pressure rise in some
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- The Outstanding Vascular Effects and Dose of Nattokinase
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References:
- Wu H, Wang H, Xu F, Chen J, Duan L, Zhang F. Acute toxicity and genotoxicity evaluations of Nattokinase, a promising agent for cardiovascular diseases prevention. Regul Toxicol Pharmacol. 2019 Apr;103:205-209. doi: 10.1016/j.yrtph.2019.02.006. Epub 2019 Feb 8. PMID: 30742876. Full text from Sci-Hub here.
- Lampe, B.J., English, J.C., 2016. Toxicological assessment of nattokinase derived from
Bacillus subtilis var. natto. Food Chem. Toxicol.: An International Journal Published
for the British Industrial Biological Research Association 88, 87–99. https://doi.org/
10.1016/j.fct.2015.12.025 - United States Food and Drug Administration, 2000. Guidance for Industry and Other Stakeholders Toxicological Principles for the Safety Assessment of Food Ingredients (Redbook 2000).
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