Chen · Frontiers in cardiovascular medicine 2022 · Non-randomized prospective clinical study · n=1,062

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

Level 3 - non-randomized controlled study

Non-randomized prospective clinical study evaluating dose responses over 12 months without reported placebo control.

PubMed 36072877 · doi:10.3389/fcvm.2022.964977 · record verified 2026-08-26

What was done

Researchers evaluated 1,062 participants over 12 months to assess the efficacy and safety of oral nattokinase at 10,800 FU/day on atherosclerosis progression and hyperlipidemia. The study also evaluated a lower dose (3,600 FU/day) and investigated the influence of lifestyle factors (smoking, alcohol consumption, BMI, regular exercise) and co-administration with vitamin K2 and aspirin.

What was found

Nattokinase at 10,800 FU/day led to significant reductions in carotid artery intima-media thickness and carotid plaque size, with improvement rates between 66.5% and 95.4%, alongside lipid profile improvements. The 3,600 FU/day dose was ineffective. Lipid-lowering was stronger in smokers, drinkers, and higher-BMI participants, with additional benefits from regular exercise and co-administration of vitamin K2 and aspirin. No noticeable adverse effects were recorded.

Why it matters

These findings suggest that antiatherosclerotic and lipid-lowering benefits of nattokinase may require substantially higher daily doses (10,800 FU/day) than the commonly used 2,000 FU/day benchmark.

Limits

The abstract omits exact baseline and post-treatment quantitative measurements (absolute lipid values and intima-media thickness in millimeters), presenting only improvement percentage ranges. Furthermore, the design lacks randomized placebo controls and blinding.

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