Dyslipidemia
Conditions
Interventions
Group 1:Simvastatin placebo, Natto Read Yeast Rice placebo
Group 2:Simvastatin placebo, Natto Read Yeast Rice capsule
Group 3:Simvastatin tablet, Natto Read Yeast Rice placebo
Group 4:Simvastatin tablet, Natto Read Yeast Rice capsule
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
35 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. 35-74 years old; 2. High LDL-C population: meeting the criteria for marginally elevated LDL-C and dyslipidemia in the 2016 Chinese Guidelines for the Management of Dyslipidemia in Adults, that is, LDL-C level ranges from 3.4 mmol/L to 5.0 mmol/L after fasting for 10 hours, without definite causes or taking lipid-lowering medications; 3. The 10-year ASCVD risk calculated by the China-PAR prediction model derived from Chinese population is 5-10%.
Exclusion criteria
Exclusion criteria: 1. Patients with definitely diagnosed cardiovascular and cerebrovascular diseases (e.g., myocardial infarction, stroke, heart failure, valve heart diseases, arrhythmias), malignant tumors, secondary hyperlipidemia; or severe gastrointestinal diseases or surgery history; or severe liver disease (ALT and/or AST are more than three times the upper limit of normal); or severe kidney disease (stages 4 and 5 chronic kidney disease, or eGFR = 140/90 mmHg when prescribed >= 3 antihypertensive medications at optimal doses); or secondary hypertension; or BMI >= 30kg/m2; 3. Patients with familial hypercholesterolemia; or statin intolerance; or TG >= 5.6 mmol/L; 4. Patients taking aspirin, warfarin or other anticoagulants; or using corticosteroids, antiretroviral or antipsychotic medications; 5. Pregnant or lactating females; 6. Patients participating in other ongoing clinical trials; 7. Other circumstances not suitable for participation considered by researchers, such as planning to become pregnant or losing weight.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low Density Lipoprotein Cholesterol;High Density Lipoprotein Cholesterol;Triglyceride;Total Cholesterol; | — |
Secondary
| Measure | Time frame |
|---|---|
| Systolic Blood Pressure;Diastolic Blood Pressure;Ankle-brachial Index;Blood Glucose;Heart Rate Variability;Carotid Intima-media Thickness;Pulse Wave Velocity;Complete Blood Count;C-Reactive Protein;Arterial Velocity Pulse Index;Arterial Pressure Volume Index; | — |
Countries
China
Contacts
Public ContactDongfeng Gu
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed