Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bioksan
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Systematic Coronary Risk Evaluation (SCORE)
研究概览
简要总结
This clinical trial seeks to verify the efficacy of a red rice yeast dietary supplement in the decrease of cardiovascular risk, by assessing variables related with cardiovascular risk as levels of cholesterol, triglycerides and transaminases among other, in two groups of participants that will be taking either the dietary supplement or a placebo during a six months period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •Body Mass Index (BMI) between 18.5 y 29.
- •LDL-c levels between 100mg/dL and 160mg/dL
- •10 year estimated cardiovascular risk assessed by the ASCVD less than 20%
- •Accepts to participate and sings Informed Consent.
排除标准
- •Patients with history of cardiovascular diseases.
- •Patients with secondary hyperlipidemia caused by diabetes mellitus, or kidney, liver or thyroid diseases.
- •Patients with muscle diseases
- •Patients undergoing pharmacological treatment with any of the following: lipid lowering agents, antifungal, macrolides, or hormone replacement therapy in progress or during the last 2 months.
- •Patients with proven intolerance with the components present in the dietary supplement.
- •Patients with any other concomitant disease that to the researcher's criteria are not susceptible to participate in the study.
- •Woman that are pregnant, in breastfeeding period or with a possibility of starting a pregnancy.
结局指标
主要结局
Systematic Coronary Risk Evaluation (SCORE)
时间窗: Changes in the score from the baseline, at 3 and 6 months.
This scale estimates the 10 year risk of fatal CVD. The risk is estimated with a High \& Low cardiovascular Risk Charts based on gender, age, total cholesterol, systolic blood pressure and smoking status, with relative risk chart, qualifiers and instructions. High risk or low risk table depends on whether the person lives in a high or low risk country. There possible scores goes from 0 to 47 in the high risk table, and 0 to 26 in the low risk table. Where lower values represent lower risk and higher values higher risk.
Arteriosclerotic Cardiovascular Disease Algorithm (ASCVD)
时间窗: Changes in the score from the baseline, at 3 and 6 months.
Calculates 10-year risk of heart disease or stroke using the ASCVD algorithm published in 2013 American College of Cardiology/American Heart Association (ACC/AHA) Guidelines on de Assessment of Cardiovascular Risk.
Registre Gironi del Cor (REGICOR)
时间窗: Changes in the score from the baseline, at 3 and 6 months.
The scale measures the probability of having cardiovascular disease in 10 years. The probability is estimated with age, sex, smoking status, diabetic or not, total Cholesterol (mg/dl), HDL cholesterol (mg/dl), systolic blood pressure (mmHg) and diastolic blood pressure (mmHg). Possible risk values are divided in 5 categories: low \<5%, moderate 6-9%, medium 10-19%, high 20-38%, very high \>39%
次要结局
- Morisky-Green scale(At the 6 month visit)
- Recount of returned product(At the 6 month visit)
- Changes in LDL cholesterol levels in blood(Changes in the cholesterol levels from the baseline, at 3 and 6 months.)
- Changes in HDL cholesterol levels in blood(Changes in the cholesterol levels from the baseline, at 3 and 6 months.)
- Changes in triglycerides levels in blood(Changes in the triglyceride levels from the baseline, at 3 and 6 months.)
- Changes in lipoprotein levels in blood(Changes in the lipoprotein levels from the baseline, at 3 and 6 months.)
- Levels of glycosylated hemoglobin in blood(Changes in the lipoprotein levels from the baseline, at 3 and 6 months.)
- Alanine Transaminase (ALT) levels(Changes in the lipoprotein levels from the baseline, at 3 and 6 months.)
- Adverse Events(Through study completion, an average of 9 months)
- Therapeutic adherence(At the 6 month visit)