Combined nattokinase with red yeast rice but not nattokinase alone has potent effects on blood lipids in human subjects with hyperlipidemia.
Level 2 - randomized trial
Randomized, double-blind, placebo-controlled clinical trial
What was done
A randomized, double-blind, placebo-controlled parallel trial evaluated lipid changes in 47 patients with hyperlipidemia over six months. Participants were randomized to three groups taking two capsules twice daily: nattokinase alone (50 mg/capsule), nattokinase combined with red yeast rice extract (300 mg extract/capsule), or placebo. Blood lipids were measured over the 6-month period.
What was found
The combined nattokinase and red yeast rice formula produced significant lipid improvements starting at month one and sustained through month six: triglycerides decreased by 15%, total cholesterol decreased by 25%, LDL-C decreased by 41%, the total cholesterol/HDL-C ratio decreased by 29.5%, and HDL-C increased by 7.5%. After adjusting for baseline levels, the combination group differed significantly from placebo for total cholesterol, LDL-C, and total cholesterol/HDL-C ratio (p < 0.0001). Nattokinase alone showed no effects until month six and did not differ significantly from placebo.
Why it matters
This trial suggests that lipid-lowering effects from combination supplements containing nattokinase and red yeast rice are driven by the red yeast rice component rather than nattokinase itself.
Limits
The total sample size was small (n = 47 across three arms, roughly 15–16 subjects per group). The study lacked a red yeast rice monotherapy arm, precluding assessment of whether nattokinase provides any additive or synergistic benefit over red yeast rice alone. The abstract does not report the monacolin content of the extract, clinical cardiovascular endpoints, or adverse event rates.
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