GuangzhouMay 29, 2026 /PRNewswire/ — On May 29, the 20th Oriental Congress of Cardiology convened in Shanghai. At the conference, Professor Gu Dongfeng from Fuwai Hospital, Chinese Academy of Medical Sciences, shared findings from a large-scale, multi-center, randomized controlled clinical study involving over a thousand participants on nattokinase and red yeast rice capsules. The clinical trial paper has been published online in JACC: Asia.
Supported by the By-Health Scientific Nutrition Research Fund, the study was conducted over several years by Fuwai Hospital, Chinese Academy of Medical Sciences, Southern University of Science and Technology, and six other medical institutions. Based on clinical trial data from a large Chinese population sample, the study confirmed that By-Health’s nattokinase and red yeast rice capsules effectively regulate blood lipid levels in individuals with mild to moderate dyslipidemia, with a favorable safety profile. This provides a new, safe, and effective nutritional intervention for early prevention and long-term health management of mild to moderate dyslipidemia in China.
Thousand-Person Study Confirms: Nattokinase and Red Yeast Rice Capsules Show Lipid-Regulating Effects in Mild to Moderate Dyslipidemia
According to the “Chinese Guidelines for Lipid Management 2023,” the prevalence of dyslipidemia among Chinese adults is as high as 35.6%. For individuals with mild to moderate dyslipidemia, proactive lipid management is crucial to prevent cardiovascular and cerebrovascular adverse events, given the potential long-term cumulative cardiovascular risks. Lifestyle intervention is a fundamental strategy for preventing and managing dyslipidemia, while statins are the mainstream lipid-lowering approach. However, many people have poor compliance due to concerns about statin side effects, creating a demand in the industry and society for safe, reliable, and long-term nutritional intervention options.
Nattokinase and red yeast rice, as traditional substances with both food and medicinal uses, are rich in nattokinase and natural lovastatin (monacolin K), respectively, and their lipid-lowering potential has attracted significant attention. Previous small-sample clinical studies have suggested their individual lipid-lowering effects, but large-scale, high-quality clinical evidence on the synergistic effects of their combination and co-administration with statins has been lacking.
To address this, Professor Gu Dongfeng’s team from Fuwai Hospital, Chinese Academy of Medical Sciences, collaborated with seven medical institutions, including Southern University of Science and Technology, the First Affiliated Hospital of China Medical University, and Fujian Provincial Hospital affiliated with Fuzhou University, mobilizing hundreds of clinical and research personnel to conduct the study.
The study employed a high-standard clinical trial design: multi-center, double-blind, double-placebo, randomized controlled. From over 10,000 participants across multiple clinical centers, 1,110 eligible patients aged 35-74 with dyslipidemia were selected. They were intervened with By-Health’s nattokinase and red yeast rice capsules and simvastatin (and their placebos) over a three-month lipid-lowering intervention.
Results showed that compared to the control group taking neither nattokinase and red yeast rice nor statins, patients who only took the nattokinase and red yeast rice capsules experienced a significant 13.21% reduction in low-density lipoprotein cholesterol (LDL-C), or “bad cholesterol,” and a 9.26% reduction in total cholesterol. Notably, when combined with simvastatin, the nattokinase and red yeast rice capsules led to an additional 5.05% reduction in “bad cholesterol” after one month compared to statin use alone, although the result did not reach statistical significance at three months. The study also found that the nattokinase and red yeast rice capsules had a good safety profile. Additionally, the research observed significant improvements in other key lipid indicators, including triglycerides, high-density lipoprotein cholesterol, and apolipoprotein B.
Overall study design and key findings
Absolute and relative changes in LDL-C at 1 month and 3 months post-intervention
Collaboration Among Multiple Medical Institutions Pioneers a New Paradigm for Nutritional Clinical Research
It is reported that this thousand-person clinical study covered five provinces and six cities across China, leveraging the strengths of each party to form a cross-regional, multi-center research network. The entire study adhered to international quality control standards for lipid testing, with data uniformly managed by the National Cardiovascular Center’s clinical trial platform. The unblinding process was independently executed by a third party to ensure objective and neutral results.
International peers commented on the study: “Previous clinical evidence on the lipid-regulating effects of the nattokinase and red yeast rice combination has been lacking. This project focuses on the clinical direction of dyslipidemia prevention and treatment, employing a multi-center, double-placebo, double-blind, randomized controlled study design. With rigorous design, substantial workload, and strict quality control, the findings provide evidence on the role of nattokinase and red yeast rice, alone and in combination with statins, in reducing LDL-C levels in patients with mild to moderate dyslipidemia.”