Chen Shufeng, Liu Fangchao, Li Jinyue, Liang Fengchao, Li Jianxin, Cao Jie, Liu Donghua, Huang Keyong, Li Hongfan, Lu Xiangfeng, Huang Jianfeng, Gu Dongfeng
Department of Epidemiology, Key Laboratory of Cardiovascular Epidemiology, Fuwai Hospital, National Center for Cardiovascular Diseases Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China.
School of Public Health and Emergency Management Southern University of Science and Technology Shenzhen China.
Chronic Dis Transl Med. 2025 Apr 24;11(2):122-129. doi: 10.1002/cdt3.70005. eCollection 2025 Jun.
Statins are the first line of treatment for dyslipidemia, but their side effects often reduce medication compliance. Natto and red yeast rice are natural ingredients with lipid-lowering effects. However, the efficacy of Natto Red Yeast Rice (NRYR) supplement in combination with statins in regulating blood lipid levels has not been fully evaluated.
A multicenter, double-blinded, randomized-controlled trial was conducted among individuals with low-density lipoprotein cholesterol (LDL-C) of 3.4 to 5.0 mmol/L at six sites in China, of those at moderate risk of cardiovascular disease (CVD) are prioritized. Participants are enrolled and randomly assigned into four groups by a combination of NRYR (or its placebo) and Simvastatin (or its placebo) in a ratio of 1:1:1:1. After examination at baseline, all participants underwent intervention for 3 months and two follow-up visits at 1 month and 3 months after the intervention. The primary outcome is the change in LDL-C level at 3 months, and secondary outcomes include changes in levels of other lipid profiles and biomarkers, as well as calculated 10-year CVD risk. A total of 1136 participants were randomly assigned, of whom 1110 received the intervention.
This study may provide new evidence for the efficacy of NRYR supplement in combination with statins to regulate lipid levels and optimize lipid management.
Chinese Clinical Trial Registry database: registration nos. ChiCTR2200064214, ChiCTR2200064215.
他汀类药物是血脂异常的一线治疗药物，但其副作用常常降低药物依从性。纳豆和红曲米是具有降脂作用的天然成分。然而，纳豆红曲米（NRYR）补充剂联合他汀类药物调节血脂水平的疗效尚未得到充分评估。
在中国六个地点对低密度脂蛋白胆固醇（LDL-C）为3.4至5.0 mmol/L、心血管疾病（CVD）中度风险的个体进行了一项多中心、双盲、随机对照试验。优先纳入参与者，并按NRYR（或其安慰剂）和辛伐他汀（或其安慰剂）1:1:1:1的比例随机分为四组。在基线检查后，所有参与者接受3个月的干预，并在干预后1个月和3个月进行两次随访。主要结局是3个月时LDL-C水平的变化，次要结局包括其他血脂谱和生物标志物水平的变化，以及计算得出的10年CVD风险。共有1136名参与者被随机分配，其中1110名接受了干预。
本研究可能为NRYR补充剂联合他汀类药物调节血脂水平和优化血脂管理的疗效提供新证据。
中国临床试验注册数据库：注册号ChiCTR2200064214、ChiCTR2200064215。
