Nattokinase atherothrombotic prevention study: A randomized controlled trial.
Level 2 - randomized trial
Double-blind randomized controlled trial
PubMed 33843667 · doi:10.3233/CH-211147
What was done
A double-blind randomized controlled trial evaluated oral nattokinase (2,000 fibrinolytic units daily) versus matching placebo in 265 individuals without clinical cardiovascular disease (median age 65.3 years). The primary outcome was the rate of change in subclinical atherosclerosis assessed every 6 months for a median of 3 years via serial carotid ultrasound measuring carotid artery intima-media thickness (CIMT) and carotid arterial stiffness (CAS). Secondary outcomes measured at least every 6 months included blood pressure, metabolic factors, blood rheology, coagulation and fibrinolysis markers, inflammatory markers, and monocyte/macrophage activation markers.
What was found
The abstract reports no numerical values, point estimates, or p-values. It states that after a median of 3 years of treatment, the annualized rate of change in CIMT and CAS did not significantly differ between nattokinase and placebo. Furthermore, nattokinase had no significant effect on blood pressure or any measured laboratory parameters.
Why it matters
This 3-year trial provides rigorous randomized evidence that standard-dose nattokinase supplementation does not reduce subclinical atherosclerosis progression or improve cardiovascular risk markers in healthy individuals.
Limits
The abstract provides no numerical data, confidence intervals, or variance measures. The study was restricted to healthy individuals at low risk for cardiovascular disease, so results cannot be extrapolated to populations with established cardiovascular disease, and only a single dose was tested.
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