Randomized, Double-blind Study to Evaluate the Effects of XXS on Oxidative Stress in Patients With Mild or Moderate Hyperlipidemia and on Lipoprotein Kinetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Quantification of Malondialdehyde (MDA)
研究概览
简要总结
Given preliminary data in animal (proprietary data) have shown that XXS (a mixture of natural polyphenolic extracts of edible plants) has a significant and favourable effect on oxidative stress notably with a decrease in certain markers of oxidative stress and on plasma lipid parameters, the investigator proposes to study the effect of 6 months of treatment with XXS in a controlled study against placebo in a population of persons presenting a lipid profile at the upper limit of normal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons who have provided written consent
- •Persons aged over 18 years
- •Presenting LDL levels between 1.30 and 1.90 g/l and/or triglyceride levels between 1.5 and 3 g/l
排除标准
- •Persons without national health insurance cover
- •Pregnant or breastfeeding women
- •Adults under guardianship
- •Patients with diabetes (Insulin-Dependent Diabetes (IDD) or Non-Insulin-Dependent Diabetes NIDD)
- •Patients with coronary artery disease
- •Patients with atherosclerosis
- •HDL>0.80 g/l
- •receiving treatment with lipid-lowering agents (statins, fibrates, ezetimibe or Ω3)
- •Consuming vitamin supplements (A, C, E…)
- •Consuming oligoelements or minerals (Se, Zn, Ca…)
- •Renal insufficiency (creatinine clearance < 30 ml/min calculated according to the Modification of the Diet in Renal Disease (MDRD))
研究组 & 干预措施
XXS
干预措施: XXS (Dietary Supplement)
Placebo
干预措施: non-XXS (Dietary Supplement)
结局指标
主要结局
Quantification of Malondialdehyde (MDA)
时间窗: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
Quantification of oxidized Low Density Lipoprotein (LDL)
时间窗: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
次要结局
- Measure of overall free-radical defences in the blood by KRL Kyrial Internationaltest(Change from baseline at 1 month, 3 months, 6 months after treatment with XXS)