Multicentre, Comparative, Double-Blind, Two-Arm Parallel Clinical Trial of the Effects of Treatment With Plantago Ovata Husk on the Lipid Profile of Patients With Hypercholesterolemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- To determine the capacity to reduce by 5% the concentrations of plasma LDL-c by treatment with soluble fibre-Plantago ovata husk- added to a low saturated fat diet in patients with moderate hypercholesterolemia.
研究概览
简要总结
The hypothesis of this study is that soluble fibre may contribute to a reduction of the low density lipoprotein cholesterol (LDL-c), and the combined effect with a statin may achieve an optimisation of the cholesterol-lowering effects in adults with several cardiovascular risk factors.
详细描述
It has been demonstrated that high concentrations of cholesterol and low density lipoprotein cholesterol (LDL, high risk cholesterol) are the major risk factors for heart disease, myocardial infarction and angina pectoris. Moreover, these conditions represent the major cause of death in the Western world.
Of the measures established to reduce blood cholesterol levels, the introduction of consumption of dietary fibre is a novelty. The term dietary fibre defines a variety of substances that are found in plants and are resistant to digestion by human gastrointestinal enzymes.
The studies performed up until now to determine the effects of fibre on blood lipids have demonstrated that consumption of soluble fibre can reduce cholesterol.
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
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Levels of LDL-c between >130 mg/dl and <189 mg/dl
- •Presence at least 1 of the cardiovascular risk factor defined as:
- •age above 45 years in men and 55 years in women
- •high blood pressure
- •HDL-c < 40 mg/dl in men and <46 mg/dl in women
- •family background of early heart disease
- •Patients who have given informed consent
- •Patients who will be capable of following diet guidelines
排除标准
- •Triglycerides >350 mg/dl
- •History of cardiovascular disease
- •treatment with statins prior to the beginning of the trial and who have not dropped out at least 2 months before the beginning of the study
- •Diabetes mellitus
结局指标
主要结局
To determine the capacity to reduce by 5% the concentrations of plasma LDL-c by treatment with soluble fibre-Plantago ovata husk- added to a low saturated fat diet in patients with moderate hypercholesterolemia.
时间窗: 16 weeks
次要结局
- To study the combined cholesterol lowering effect of treatment with Plantago ovata husk and statins to achieve the therapeutic objective(16 weeks)
- To analyse the effect of Plantago ovata husk fibre on blood pressure(16 weeks)
- To evaluate whether the response on plasma lipids is modulated by the polymorphisms of apolipoprotein E, cholesterol ester transfer protein (CETP), apolipoprotein A-V and Fatty acid binding protein 2 (FABP2)(16 weeks)