Randomized Clinical Trial, Controlled Against Placebo, Performed to Evaluate the Effect of a Phytosterol-based Product (2.5 g/Day), After 3 Weeks of Intake, on the Lipid Profile, Also in Relation to the Quality of the Diet, in Subjects With Moderate Hypercholesterolemia and Low / Moderate Global Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Fasting lipid profile
研究概览
简要总结
DESCO is a randomized clinical trial, controlled against placebo, performed to evaluate the effect of a phytosterol-based product (2.5 g/day), after 3 weeks of intake, on the lipid profile, also in relation to the quality of the diet, in subjects with moderate hypercholesterolemia and low / moderate global cardiovascular risk.
详细描述
This is a randomized, placebo-controlled, double-blind, monocentric cross over clinical study conducted in Italy.
The objective of this study is to evaluate the fasting lipid profile of adults with moderate hypercholesterolemia and a low/very low cardiovascular risk, after 3 weeks of supplementation with 2.5 g/day of plant sterols, vs placebo, and to assess the relationship between the effects of the supplementation and the diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Total cholesterol plasma levels between 200 and 240 mg/dL and/or LDL cholesterol levels between 130 and 160 mg/dL
- •Triglyceride plasma levels <200 mg / dL
- •Cardiovascular risk at 10 years (according to the SCORE algorithm) <5%.
- •Signature of the informed consent form
排除标准
- •Subjects in secondary prevention for cardiovascular diseases or with a global cardiovascular risk (according to the SCORE algorithm) > 5% at 10 years
- •Triglyceride plasma levels >200 mg / dL
- •Decompensated diabetes
- •Alcoholism
- •Food allergy
- •Recent intake of functional foods or supplements for cholesterol control
- •Intake of lipid-lowering drugs or drugs affecting lipid metabolism in the last 2 months
- •Alterations in thyroid, hepatic or renal function (transaminases greater than 3 times the maximum values; glomerular filtration rate <30ml / min), muscle diseases, even if subclinical
- •Obesity (BMI> 30)
- •Any medical or surgical condition that could make the patient's adherence to the study protocol complex or inconstant.
结局指标
主要结局
Fasting lipid profile
时间窗: 3 weeks
Evaluation of the effects of the intake of phytosterols on fasting lipid profile, including the following parameters: total and LDL cholesterol, triglycerides, HDL cholesterol, plasma levels of apolipoproteinB-100.
次要结局
- Weight(3 weeks)
- BMI(3 weeks)
- Blood pressure(3 weeks)
- Mediterranean index of the diet assessed by validated FFQ(3 weeks)
- Abdominal circumference(3 weeks)
研究者
Claudio Borghi
Professor
University of Bologna