The Effect of Nattokinase-Monascus Supplements on Dyslipidemia: A Four-Month Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 37836525 · doi:10.3390/nu15194239
What was done
A randomized, double-blind, placebo-controlled trial evaluated the effects of nattokinase-monascus supplements (NMSs) on cardiovascular biomarkers and carotid intima-media thickness (CIMT) in 113 patients with dyslipidemia. Participants were randomly assigned to receive either NMSs (n = 55) or placebo (n = 58) for 120 days. Outcomes included serum lipids (total cholesterol, LDL-C, HDL-C, non-HDL-C, triglycerides), LDL-C/HDL-C ratio, CIMT, coagulation markers, safety labs (liver and renal function), and adverse events.
What was found
After 120 days, the NMS group demonstrated significant mean absolute changes compared with placebo in total cholesterol (-0.52 mmol/L, 95% CI: -0.51 to -0.54), LDL-C (-0.43 mmol/L, 95% CI: -0.45 to -0.41), non-HDL-C (-0.52 mmol/L, 95% CI: -0.52 to -0.52), and the LDL-C to HDL-C ratio (-0.29, 95% CI: -0.30 to -0.28). No significant differences were observed for triglycerides, HDL-C, or CIMT. No significant differences were found in coagulation, liver, or renal function tests, and no intervention-related adverse events were reported.
Why it matters
This study provides evidence that four months of combined nattokinase and monascus supplementation can modestly improve atherogenic lipid fractions in dyslipidemia without apparent adverse effects on liver, renal, or coagulation function.
Limits
The trial had a modest sample size (n = 113) and a 120-day follow-up period, which is too brief to evaluate hard clinical cardiovascular endpoints or long-term structural changes in CIMT. Specific supplement dosages and monacolin K content were not reported in the abstract.
Cited by
- context Supplementing with nattokinase can reduce LDL cholesterol levels.