Lipid Profile and Vascular Remodelling in Young Dyslipidemic Subjects Treated With Nutraceuticals Derived From Red Yeast Rice.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline in cholesterol levels at one year
研究概览
简要总结
Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular prevention in a setting of controlled dietary habits. The nutraceutical combination used in this study consists of a single pill containing 333 mg of RYR, equivalent to 10 mg of Monacolin K, and 30 mg of Coenzyme Q10 (CoQ10).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Total Cholesterol > 150 mg/dl and < 250 mg/dl;
- •Triglycerides > 150 mg/dl and < 500 mg/dl;
- •Fasting glucose < 126 mg/dl;
- •Stable antihypertensive treatment (at least for 6 months) in presence of hypertension.
排除标准
- •Total Cholesterol > 250 mg/dl
- •Triglycerides > 500 mg/dl
- •Previous statin therapy (last 6 months);
- •Treatment with hypoglycemic agents and/or fasting glucose > 126 mg/dl;
- •Chronic gastrointestinal disorders;
- •Chronic kidney disease (eGFR < 60 ml/min/1.73 m2);
- •Concomitant treatment with drugs potentially interfering with glucose and lipid metabolism; - History of cardiovascular diseases;
- •Proven intolerance to any component of the nutraceutical product;
- •Pregnancy or breastfeeding.
结局指标
主要结局
Change from baseline in cholesterol levels at one year
时间窗: Baseline and one year
Total Cholesterol will be measured in the blood sample from each patient and expressed as mg/dl
Change from baseline in carotid intima media thickening at one year
时间窗: Baseline and one year
Carotid ultrasound examination is performed at baseline and after one year to measure intima-media thickness (IMT). IMT is defined as the distance in mm between the lumen-intima and the media-adventitia interfaces, it is measured at end diastole in the far wall of the right and left sides of the common carotid artery, the bulb and the internal carotid artery. Carotid IMT measurements are expressed as cumulative mean of mean-IMT (m-IMT) recorded in each vascular segment .
次要结局
未报告次要终点
研究者
Marcello Rattazzi
Associate Professor
University of Padova