Effect of the Food Supplement LIMICOL on LDL Cholesterol and Muscle Function in Subjects Who Undergo a Program of Physical Training (Double-blind, Randomized, Placebo-controlled Study).
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
- 8
- 主要终点
- LDL-cholesterol levels (g/l) at the end of study
研究概览
简要总结
Cardiovascular disease (CVD), foremost among which ischemic heart disease and stroke, are the leading cause of mortality and morbidity in France. These diseases are multifactorial origin and even if it is not possible to act on risk markers such as age, sex, or heredity, risk factors like high cholesterol, smoking , hypertension, obesity, diabetes and physical inactivity, are the main target of prevention strategies. Dydlipidemias have a role in the formation of CVD in participating in the genesis of atherosclerosis. The cholesterol and LDL-cholesterol in particular is subject to oxidation process in plasma. The molecules of oxidized LDL-cholesterol, small and dense, easily penetrate the arterial endothelial wall and are greeted by macrophages. Following a succession of different processes including inflammation, atherosclerotic plaque is formed. The result is either an arteriopathy when the arterial lumen narrowing, or atherothrombosis in the event of plaque rupture. Given this pathophysiology, reduce blood lipids, including LDL-cholesterol and reducing oxidation and inflammation are interesting strategies in the context of cardiovascular prevention. Several scientific study showed that nutritional supplementation with some plant extracts such as artichokes, garlic, red yeast rice, or the sugar cane policosanol helps to reduce several cardiovascular risk factors including regulate concentrations of circulating lipids.
In this study, we hypothesize that the food supplement LIMICOL contributes to reducing LDL cholesterol in the context of care for patients (dietary measures and physical activity)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •BMI between 25 and 35 kg/m²
- •Subject has a stable weight for at least three months before the start of the study.
- •LDL ≥ 1.50 g/L
- •0.9 g/L ≤ triglycerides ≤ 4.00 g/L
- •Subject able and willing to comply with the protocol and agreeing to give his informed consent in writing;
- •Subject affiliated with a social security scheme
排除标准
- •Subject having a confirmed or suspected food allergy, notably to one of the components of the study product;
- •Subject suffering from a severe chronic condition deemed incompatible with participation in the study by the investigator
- •Subject with glaucoma
- •Subject with uretroprostatic disorder
- •Subjet anxious (score >9 HAD scale)
- •Subject with diabetes
- •Subjet with treatment anticoagulant
结局指标
主要结局
LDL-cholesterol levels (g/l) at the end of study
时间窗: Week 12
Effect of LIMICOL supplementation showed by ANCOVA analysis of LDL cholesterol (g/l), with baseline LDL as covariable
次要结局
- HDL-cholesterol(Week 0; Week 6; Week 12)
- Glycemia(Week 0; Week 12)
- Insulinemia(Week 0; Week 12)
- Albumin(Week 0; Week 12)
- ApoA1(Week 0; Week 12)
- ALT(Week 0; Week 12)
- ALP(Week 0; Week 12)
- GGT(Week 0; Week 12)
- Total cholesterol(Week 0; Week 6; Week 12)
- Triglycerides(Week 0; Week 6; Week 12)
- CoQ10(Week 0; Week 12)
- Myoglobin(Week 0; Week 12)
- LD(Week 0; Week 12)
- Urea(Week 0; Week 12)
- Weight(Week 0; Week 6; Week 12)
- Muscle function on tissue biopsy(Week 0; Week 12)
- LDLox(Week 0; Week 6; Week 12)
- ApoB(Week 0; Week 12)
- CK(Week 0; Week 12)
- AST(Week 0; Week 12)
- usCRP(Week 0; Week 12)
- Creatinin(Week 0; Week 12)
- VO2 MAX(Week 0; Week 6; Week 12)
- Fat mass(Week 0; Week 12)
- Bilirubin(Week 0; Week 12)
- Total Protein(Week 0; Week 12)
- Max Strength(Week 0; Week 6; Week 12)