Gut Microbiota and Bile Acids Mediate the Clinical Benefits of Red Yeast Rice for Primary Prevention of Hypercholesterolemia: A Pilot Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Low Density Lipoprotein-Cholesterol (LDL-C)
研究概览
简要总结
This two-year observational study will be conducted at the outpatient clinic of the Department of Traditional Chinese Medicine of Taoyuan Chang Gung Hospital from February 26, 2024 to December 31, 2025. This study will enroll 35~55 year-old male patients who are expected to take LipoCol Forte Capsules for primary prevention of hypercholesterolemia. The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. This study will evaluate the efficacy, durability and safety of LipoCol Forte capsules in the primary prevention of hypercholesterolemia in patients with different constitutions, as well as whether it can reduce the risk of cardiovascular disease, and its influence on bile acid metabolism and intestinal microbiota.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged 35~55 years old
- •LDL-C≥130mg/dl or patients with diabetes or chronic kidney disease with LDL-C ≥ 100mg/dl
- •expected to receive LipoCol Forte Capsule 600mg bid
排除标准
- •Have received anti-hyperlipidemic drugs or red yeast rice treatment within the past month;
- •Have experienced rhabdomyolysis or abnormal liver function ALT >72 U/L due to taking red yeast rice;
- •Bleeding diseases, such as abnormal platelets, abnormal coagulation factors, or gastrointestinal tract infection within one month
- •Liver insufficiency ALT >72 U/L or renal insufficiency eGFR < 30 mL/min/1.73 m2;
- •Have ever had coronary heart disease, myocardial infarction or cerebrovascular disease;
- •Stressful situations, including hospitalization or surgery within the past or next month, and cancer still being treated;
- •Uncontrolled hypertension (blood pressure ≥160/100 mmHg);
- •Use antibiotics, probiotics or weight-loss drugs for more than 3 consecutive days within 3 months before inclusion in the study;
- •Drug abuse or poor compliance;
- •Use of traditional Chinese medicine in the past month
结局指标
主要结局
Low Density Lipoprotein-Cholesterol (LDL-C)
时间窗: before treatment, and 3, 6, 9, 12 months after treatments
This study will evaluate the efficacy and durability of LipoCol Forte capsules in the primary prevention of hypercholesterolemia.
次要结局
- 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Risk(before treatment, and 3, 6, 9, 12 months after treatments)