GUANGZHOUMay 30, 2026 /PRNewswire/ — Recently, supported by the By-Health Scientific Nutrition Research Fund, Fuwai Hospital of the Chinese Academy of Medical Sciences, Southern University of Science and Technology, in collaboration with six other medical professional institutions, completed a thousand-person multicenter clinical study on nattokinase red yeast rice capsules over six years. The study, which used By-Health’s nattokinase red yeast rice capsules as the intervention, is the first thousand-person, multicenter, randomized, double-blind clinical trial on lipid-lowering with nattokinase red yeast rice in the dietary supplement field. The results were published in the international cardiovascular journal Journal of the American College of Cardiology: Asia.
The study confirmed for the first time in a large-scale Chinese population that nattokinase red yeast rice capsules effectively regulate blood lipids and exhibit a synergistic effect when combined with statin drugs, offering a safe and effective non-pharmacological intervention option for individuals with mild to moderate dyslipidemia.
Thousand-Person Clinical Evidence: By-Health Nattokinase Red Yeast Rice Capsules Show Significant Lipid-Lowering Effects
Clinical evidence shows that compared to a control group not taking either nattokinase red yeast rice or statins, subjects who only took nattokinase 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, with a good safety profile. More notably, when nattokinase red yeast rice capsules were used in combination with simvastatin, subjects saw an additional 5.05% reduction in “bad cholesterol” levels after one month compared to statin use alone. The study also found that nattokinase red yeast rice had a favorable safety profile. Additionally, the research observed significant improvements in other key lipid indicators, including triglycerides, high-density lipoprotein cholesterol, and apolipoprotein B.
These findings address a pressing real-world need in lipid management. According to the 2023 Chinese Guidelines for Lipid Management, the prevalence of dyslipidemia among Chinese adults is as high as 35.6%. For individuals with mild to moderate dyslipidemia, given the potential long-term cardiovascular risks, proactive lipid management is crucial to prevent adverse cardiovascular and cerebrovascular events. While statins are the mainstream lipid-lowering therapy, many people have poor compliance due to concerns about side effects. Exploring safe, reliable, and long-term nutritional intervention options has become a focus of the industry and a societal need.
Nattokinase red yeast rice, as a natural substance with both food and medicinal properties, is rich in nattokinase and lovastatin (monacolin K). The lovastatin in nattokinase red yeast rice can reduce the production of “bad cholesterol” at its source by inhibiting the activity of a key rate-limiting enzyme in cholesterol synthesis, thereby exerting a lipid-lowering effect.
Although previous clinical studies have confirmed the individual lipid-lowering effects of nattokinase and red yeast rice, the study scales were generally limited. This clinical study, based on a Chinese population, provides more compelling, large-scale, high-quality clinical evidence, confirming that nattokinase red yeast rice capsules can effectively regulate blood lipid levels in individuals with mild to moderate dyslipidemia. Furthermore, this thousand-person study also validated the synergistic effect of combining nattokinase red yeast rice with statin drugs.
Strong Collaboration Among Multiple Medical Institutions Creates a New Paradigm for Nutritional Clinical Research
Behind this high-standard study lies deep synergy in scientific research efforts and an active exploration of industry-academia-research collaboration. Supported by the By-Health Scientific Nutrition Research Fund, Fuwai Hospital of the Chinese Academy of Medical Sciences and Southern University of Science and Technology, together with six other medical professional institutions including the First Affiliated Hospital of China Medical University and Fujian Provincial Hospital affiliated with Fuzhou University, organized over 500 clinical and scientific researchers to conduct the study over six years.
The study employed a high-standard clinical trial design featuring multicenter, double-blind, double-placebo, randomized controlled methodology. From over 10,000 individuals across multiple clinical centers nationwide, 1,110 subjects aged 35-74 with dyslipidemia were selected. By-Health nattokinase red yeast rice capsules and simvastatin, along with their placebos, were used as interventions for a three-month lipid-lowering regimen.
This thousand-person clinical study covered five provinces and six cities across China, leveraging the technical strengths of each party to form a cross-regional, multicenter, large-sample research network. The entire study adhered to internationally stringent quality control standards for blood lipid testing. Data were uniformly managed by the Clinical Trial Platform of the National Center for Cardiovascular Diseases, and the unblinding process was independently executed by a third party to ensure objective and neutral results.
Industry experts stated that the study’s rigorous design and strict quality control elevate clinical research in the nutrition field to a new level. It not only fills the gap in large-scale evidence for nattokinase red yeast rice but also contributes Chinese population data for updating lipid management guidelines. Moreover, it provides crucial evidence to support personalized interventions for individuals with varying degrees of dyslipidemia and the scientific, standardized application of nattokinase red yeast rice.
As a leading global dietary supplement company, By-Health is committed to pooling scientific research efforts to deepen basic and applied research related to dietary supplements. In the future, By-Health will adhere to its scientific nutrition strategy, continue to delve into the cardiovascular health field, and advance cutting-edge explorations such as clinical research on raw materials and products, and lipidomics analysis. The goal is to provide the public with more precise health solutions and contribute to the construction of China’s primary cardiovascular disease prevention system.