Artichoke and Bergamot Phytosome: a Randomized Double Blind Clinical Trial in Bergamot Poor-responders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes of lipid parameters
研究概览
简要总结
According to WHO data, about 50% of deaths each year are caused by cardiovascular disease. One of the strategies for prevention of cardiovascular diseases, in addition to a correct lifestyle, is to implement therapies that reduce the level of cholesterol in the blood and at the same time control the glycemic levels, which are closely related in the maintenance of metabolic homeostasis. The aim of this clinical study is to confirm the potential broader activity as hypocholesterolemic agent in bergamot poor-responders subjects with mild hypercholesterolemia. The study was a 8-week randomized double-blind placebo-controlled trial. Participants were randomized to either the supplement based on dry extract from artichoke leaf and bergamot phospholipid (31) or placebo arm (29).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mild hypercholesterolemia (220 - 280 mg/dl)
- •subjects were not taking any medication likely to affect lipid metabolism (such as statins)
- •subjects were bergamot poor-responders
排除标准
- •liver, renal and thyroid diseases
- •history of cardiovascular disease (CVD)
结局指标
主要结局
Changes of lipid parameters
时间窗: Baseline / 30 days / 60 days
Total cholesterol, LDL cholesterol, HDL cholesterol (mg/dl)
次要结局
- Changes of lipid parameters(Baseline / 30 days / 60 days)
- Changes of body composition(Baseline / 30 days / 60 days)
- Changes of safety parameters(Baseline / 30 days / 60 days)
- Changes of metabolic parameters(Baseline / 30 days / 60 days)
- Changes of anthropometric measurements(Baseline / 30 days / 60 days)