The Effect of Bergamot on Plasma Lipids, Lipoproteins and Carotid Intima-media Thickness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change from baseline in plasma lipids
研究概览
简要总结
Bergamot-derived products have shown significant effects on plasma lipids. We aim in the present study to evaluate the effect of bergamot on several cardio-metabolic risk markers.
详细描述
The research hypothesis is to assess whether bergamot reduces plasma lipids (total cholesterol, triglycerides, low-density lipoprotein (LDL)-cholesterol and high-density lipoprotein (HDL)-cholesterol), atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis in patients with dyslipidemia.
The primary objective is to assess whether bergamot reduces plasma lipids and atherogenic lipoproteins in patients with dyslipidemia.
Primary endpoint: Reduction in plasma lipids and atherogenic lipoproteins. The secondary objective is to assess whether bergamot reduces carotid intima-media thickness (IMT) and liver steatosis in patients with dyslipidemia.
Secondary endpoint: Reduction in IMT and and liver steatosis.
Clinical diagnostic tools will include the measurement of:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elevated LDL-cholesterolemia
排除标准
- •severe hepatic or renal diseases
结局指标
主要结局
Change from baseline in plasma lipids
时间窗: baseline and 6 months
We will measure at baseline and after 6 months the following plasma lipids concentrations: total cholesterol, triglycerides, LDL-cholesterol and HDL-cholesterol.
次要结局
- Change from baseline in atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis(baseline and 6 months)
研究者
Manfredi Rizzo
Assistant Professor
University of Palermo