JACC. Asia · 2026
Natto Red Yeast Rice Supplement Regulates Lipid Profiles: A Multicenter, Double-Placebo, Double-Blinded, Randomized Controlled Trial.
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Liu Fangchao, Chen Shufeng, Liang Fengchao, Li Jianxin, Huang Keyong, Sun Yingxian, Wang Qing, Wu Shouling, Ma Mingfeng, Yu Ling, Lin Jinchun, Lu Xiangfeng, Huang Jianfeng, Gu Dongfeng
Аннотация
BACKGROUND: Natto Red Yeast Rice (NRYR) is a dietary supplement used to lower blood lipid. However, evidence on its effects on regulating lipid levels is limited.
OBJECTIVES: The aim of this study was to assess whether NRYR can lower low-density lipoprotein cholesterol (LDL-C) levels and regulate other lipids, both alone and in addition to simvastatin.
METHODS: We enrolled 1,110 participants who were randomized into 4 groups to receive a 3-month intervention of placebo, NRYR (1,950 mg/d), simvastatin (20 mg/d), or NRYR (1,950 mg/d) plus simvastatin (20 mg/d). The primary outcome was the change in LDL-C levels after 3 months, which were evaluated using linear mixed models. The primary analyses were conducted according to the modified intention-to-treat principle. Safety outcomes were also recorded.
RESULTS: Significant reductions in LDL-C levels were observed in the NRYR, simvastatin, and combination group. The differences in the absolute/percent change in LDL-C levels from baseline to 3 months were -21.02 mg/dL (95% CI: -27.98 to -14.06 mg/dL)/-13.21% (95% CI: -17.88% to -8.54%), -25.80 mg/dL (95% CI: -32.64 to -18.97 mg/dL)/-17.08% (95% CI: -21.67% to -12.50%), and -32.74 mg/dL (95% CI: -39.74 to -25.73 mg/dL)/-21.22% (95% CI: -25.92% to -16.52%), respectively, compared with placebo (all P < 0.001). Compared with simvastatin alone, adding NRYR demonstrated a significant decrease in LDL-C levels with a net absolute/percent change of -7.95 mg/dL (95% CI: -13.79 to -2.11 mg/dL; P = 0.008)/-5.05% (95% CI: -8.87% to -1.24%; P = 0.009) at 1 month, but the effect was not significant at 3 months. Adverse event rates were similar across the 4 groups.
CONCLUSIONS: NRYR alone lowered LDL-C levels, and its combination with simvastatin was associated with numerically but not significantly lower LDL-C levels than using simvastatin alone. (ChiCTR2200064214, ChiCTR2200064215).
OBJECTIVES: The aim of this study was to assess whether NRYR can lower low-density lipoprotein cholesterol (LDL-C) levels and regulate other lipids, both alone and in addition to simvastatin.
METHODS: We enrolled 1,110 participants who were randomized into 4 groups to receive a 3-month intervention of placebo, NRYR (1,950 mg/d), simvastatin (20 mg/d), or NRYR (1,950 mg/d) plus simvastatin (20 mg/d). The primary outcome was the change in LDL-C levels after 3 months, which were evaluated using linear mixed models. The primary analyses were conducted according to the modified intention-to-treat principle. Safety outcomes were also recorded.
RESULTS: Significant reductions in LDL-C levels were observed in the NRYR, simvastatin, and combination group. The differences in the absolute/percent change in LDL-C levels from baseline to 3 months were -21.02 mg/dL (95% CI: -27.98 to -14.06 mg/dL)/-13.21% (95% CI: -17.88% to -8.54%), -25.80 mg/dL (95% CI: -32.64 to -18.97 mg/dL)/-17.08% (95% CI: -21.67% to -12.50%), and -32.74 mg/dL (95% CI: -39.74 to -25.73 mg/dL)/-21.22% (95% CI: -25.92% to -16.52%), respectively, compared with placebo (all P < 0.001). Compared with simvastatin alone, adding NRYR demonstrated a significant decrease in LDL-C levels with a net absolute/percent change of -7.95 mg/dL (95% CI: -13.79 to -2.11 mg/dL; P = 0.008)/-5.05% (95% CI: -8.87% to -1.24%; P = 0.009) at 1 month, but the effect was not significant at 3 months. Adverse event rates were similar across the 4 groups.
CONCLUSIONS: NRYR alone lowered LDL-C levels, and its combination with simvastatin was associated with numerically but not significantly lower LDL-C levels than using simvastatin alone. (ChiCTR2200064214, ChiCTR2200064215).