1. Introduction
−0.51, stomach pain, CIMT.Hyperlipidemia, stroke, −0.52, drooling, TG, coronary artery disease, single-strain
DYSLIPIDEMIA, ADVERSE EVENTS, STROKE, MOUTH ULCERS, VASCULAR DISORDERS, CORONARY ARTERY DISEASE, DYSLIPIDEMIA
These authors contributed equally to this work.Dyslipidemia, a condition implying high cardiovascular risks, has been widely studied on its potential nutrition interventions, including functional foods. This study aims to examine the effect of nattokinase monascus supplements (NMSs) on cardiovascular biomarkers and carotid intima-media thickness (CIMT) in patients with dyslipidemia. A total of 113 eligible subjects were randomly assigned to receive either NMSs or a placebo (55 and 58, respectively). After a 120-day intervention, there were significant mean absolute changes in total cholesterol (TC), low-density cholesterol (LDL-C), non-high-density cholesterol (non-HDL-C), and low-density cholesterol to high-density cholesterol ratio (LDL-C to HDL-C ratio), with values of −0.52 (95% CI: −0.51 to −0.54) mmol/L, −0.43 (95% CI: −0.45 to −0.41) mmol/L, −0.52 (95% CI: −0.52 to −0.52) mmol/L, and −0.29 (95% CI: −0.30 to −0.28) mmol/L, respectively, between the two groups. However, no significant differences were found in triglycerides (TGs), high-density cholesterol (HDL-C), and CIMT. Furthermore, the results for lipids and CIMT remained essentially unchanged after adjusting for various confounding factors using the analysis of covariance model. There were no significant differences in coagulation, liver function, renal function, or other indicators. No intervention-related adverse events, such as mouth ulcers, drooling, and stomach pain, were reported. The study results demonstrate that NMSs can ameliorate lipid levels (TC, LDL-C, non-HDL-C, and the LDL-C to HDL-C ratio) without the occurrence of adverse events. However, it did not significantly affect serum TG, HDL-C, and CIMT.Hyperlipidemia is a significant contributor to the development of atherosclerosis-associated vascular disorders, including coronary artery disease and stroke [Natto, a fermented soybean product from China, has been used for many years with rare safety disputes [Although several studies on single-strain fermentation have been widely studied [Therefore, we conducted a randomized, double-blind, placebo-controlled trial to examine the effect and safety of NMSs on patients with dyslipidemia.