Combined Effects of Bioactive Compounds (ARMOLIPID PLUS ®) on Lipid Profile and Clinical Criteria of Metabolic Syndrome in Patients With Serum Elevated LDL-C
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- investigate whether the addition of Armolipid Plus ® decreases by 20% LDL-C levels compared to baseline in patients with initial levels of LDL-C ≥ 130 mg / dL.
研究概览
简要总结
The aim of this study is to demonstrate whether, along with dietary recommendations, Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III (ATP III)
详细描述
Recently reported that the combination of extract of red yeast rice policosanol composed, berberine, folic acid and coenzyme Q10 (Armolipid Plus ®, Rottapharm) produced a significant improvement in lipid profile in patients with moderately elevated cholesterol levels of low density lipoprotein (LDL-C) plasma.
Taking into account the potential effect of Armolipid Plus ® on the lipid profile, it is important to investigate the effectiveness in the field of cardiovascular prevention to define its position in prevention programs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients > 18 years old
- •LDL-c plasma levels ≥130 mg/dL and ≤ 189 mg/dL
- •Patients not requiring lipid-lowering drug treatment according to ATPIII guidelines,that do not have cardiovascular disease, stroke or intermittent claudication, diabetes mellitus, renal or Patients who have demonstrated effects or contraindications to lipid-lowering drug therapy (in this case, treatment should be discontinued 1 month before baseline.
- •Signed and dated informed consent before any study specific procedure.
排除标准
- •Patients on drug therapy to reduce LDL-C, for example, statins, bile acid sequestrants, nicotinic acid, fibrates or similar (up to 1 month before baseline).
- •History of cardiovascular disease, stroke or intermittent claudication.
- •Diabetes mellitus (at least 2 blood fasting glucose greater than 126 mg / dL).
- •Having taken any functional food with sterols, stanols or similar or any nutraceutical with lipid-lowering effects during the previous 7 days.
- •Plasma levels of triglycerides > 350 mg/dl
- •Diagnosis of familial hypercholesterolemia
结局指标
主要结局
investigate whether the addition of Armolipid Plus ® decreases by 20% LDL-C levels compared to baseline in patients with initial levels of LDL-C ≥ 130 mg / dL.
时间窗: twelve weeks
次要结局
- Cardiovascular risk (according to the Framingham tables).(twelve weeks)
- Criteria for Metabolic Syndrome(twelve weeks)
- Levels of triglycerides and cholesterol high density lipoprotein (HDL-C).(twelve weeks)