Pilot Study to Evaluate the Effect of the Consumption of a Combination of Plant Extracts (BSL_EP025) on the Levels of LDL-cholesterol and Oxidized LDL-cholesterol in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- LDL cholesterol
研究概览
简要总结
The objective of the study is to evaluate the ability of a combination of plant extracts (BSL_EP025) to reduce the levels of LDL-cholesterol and oxidized LDL-cholesterol in individuals with LDL-cholesterol levels between 100 and 190 mg/dL.
详细描述
There is a strong relationship between serum cholesterol levels and cardiovascular diseases, especially between coronary artery disease and LDL-cholesterol (LDL).
LDL is the lipoprotein responsible for delivering cholesterol to cells. However, in recent years, special attention has been given to modified LDL, especially oxidized LDL, since it plays a very important role in the initiation and progression of the atheroma plaque.
There are environmental and genetic factors that can influence the type and levels of blood lipoproteins. Among the modulable factors (environmental) it has been observed that some phytochemical compounds found in several plant extracts may reduce cardiovascular risk, due to their antioxidant and anti-inflammatory properties.
The objective of the present study is to evaluate the possible effect of the intake of a combination of plant extracts (BSL_EP025) on the levels of LDL-cholesterol and oxidized LDL-cholesterol in healthy individuals with LDL-cholesterol levels between 100 and 190 mg/dL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men or women between 18 and 65 years of age.
- •Levels of LDL-cholesterol between 100 and 190 mg/dL.
- •Accept freely to participate in the study and sign the informed consent document.
排除标准
- •Be pregnant.
- •Have planned to carry out a dietary intervention or exercise practice with the aim of losing weight in the coming weeks.
- •Suffer from a serious illness.
- •Have diabetes.
- •Having a cerebrovascular disease.
- •Be taking products or drugs to control cholesterol levels or with antioxidant activity.
结局指标
主要结局
LDL cholesterol
时间窗: 8 weeks
Levels of LDL cholesterol in plasma
Oxidized LDL cholesterol
时间窗: 8 weeks
Levels of oxidized LDL cholesterol in plasma
次要结局
- Triglycerides(8 weeks)
- Glucose(8 weeks)
- Beta IL-1(8 weeks)
- IL-6(8 weeks)
- ICAM-1(8 weeks)
- IL-10(8 weeks)
- Total cholesterol(8 weeks)
- HDL cholesterol(8 weeks)
- Blood pressure(8 weeks)
- Body mass index(8 weeks)
- VCAM-1(8 weeks)