Evaluation of NaTto Red Yeast Rice on Regulating Blood Lipid (ENTRY) Study: A Multicenter, Double-Placebo, Double-Blinded, Randomized Controlled Trial in Chinese Adults
- VernacularTitle:Evaluation of NaTto Red Yeast Rice on Regulating Blood Lipid (ENTRY) Study: A Multicenter, Double-Placebo, Double-Blinded, Randomized Controlled Trial in Chinese Adults
- Author:
Shufeng CHEN
1
;
Fangchao LIU
;
Jinyue LI
;
Fengchao LIANG
;
Jianxin LI
;
Jie CAO
;
Donghua LIU
;
Keyong HUANG
;
Hongfan LI
;
Xiangfeng LU
;
Jianfeng HUANG
;
Dongfeng GU
Author Information
- Publication Type:Journal Article
- Keywords: dyslipidemia; efficacy; randomized controlled trial; red yeast rice; simvastatin
- From: Chronic Diseases and Translational Medicine 2025;11(2):122-129
- CountryChina
- Language:English
- Abstract: Background::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.Methods::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.Discussion::This study may provide new evidence for the efficacy of NRYR supplement in combination with statins to regulate lipid levels and optimize lipid management.Trial Registration::Chinese Clinical Trial Registry database: registration nos. ChiCTR2200064214, ChiCTR2200064215.
