Randomized Controlled Clinical Trial for Assessing Tolerability and Effectiveness of Formula Coleosoma 29 in Patients With Dyslipidemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change from baseline values of non-HDL cholesterol (mg/dl) after 12 weeks of coleosoma treatment vs placebo
研究概览
简要总结
The overall objective of the study is to assess the efficacy of Coleosoma formulation (fermented red rice, berberine and chitosan) in reducing non-HDL cholesterol in dyslipidemic patients.
详细描述
The incidence of cardiovascular diseases related to atherosclerosis is the leading cause of death in industrialized countries and in many developing countries. It becomes, therefore, essential to implement preventive strategies with lifestyle changes in order to prevent / control the risk factors related to cardiovascular disease.
Dyslipidemia is characterized by qualitative and quantitative alterations of plasma lipids and lipoproteins. In subjects where it is not yet indicated a statin therapy, the guidelines recommend a lifestyle (diet and exercise) act to control cardiovascular risk factors.
The formulation Coleosoma is a supplement composed of fermented red rice, berberine and chitosan. Aim of the study is to evaluate the effectiveness of coleosoma formulation in reducing non-HDL cholesterol (Non-HDL-C), which provides a measure of the cholesterol content in all atherogenic particles.
This is a single-center, randomized (3:1) and controlled double-blind phase II study that involve dyslipidemic patients with non-HDL cholesterol levels ≥ 160 mg / dl.
The study included a maximum of 4 visits for all subjects enrolled. All eligible patients at V0 (screening) undergo baseline assessments (V1) and have been allocated according to the procedure of randomization to one of the study arms. Follow-up (FU) visits for all subjects was at 4 (V2) and at 12 weeks (V3) after randomization.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-HDL cholesterol ≥ 160 mg/dl;
- •providing their written Informed Consent;
- •capable of understanding the nature, purpose and study procedures
排除标准
- •diabetes (ADA criteria)
- •reduced renal (GFR<60 mL/min/1.73m2) or hepatic (transaminase levels >2.5 folds the upper reference limit) function;
- •present or past history of alcohol or drug abuse
- •cerebro-vascular and neoplastic diseases in the 5 years prior to study visit
- •use of drugs or food supplements interfering with cholesterol levels
- •pregnancy or breastfeeding;
- •monogenic dyslipidemia;
- •participation in other clinical trials in the previous 30 days;
- •uncompensated hypothyroidism
结局指标
主要结局
Change from baseline values of non-HDL cholesterol (mg/dl) after 12 weeks of coleosoma treatment vs placebo
时间窗: 12 weeks
Difference in the non-HDL cholesterol value compared to baseline in the 2 arms.
次要结局
- change from baseline values of non-HDL cholesterol (mg/dl) at 4 weeks of coleosoma treatment vs placebo(4 weeks)
- change from baseline values of Free Plasma Glucose (mg/dl) at 12 weeks of coleosoma treatment vs placebo(12 weeks)
- change from baseline values of Body Mass Index (Kg/m2) at 12 weeks of coleosoma treatment vs placebo(12 weeks)
- Change from baseline values of LDL Cholesterol, triglycerides and HDL cholesterol at 12 weeks of coleosoma treatment vs placebo(12 weeks)
- Change from baseline values of insulin (pmol/l) at 12 weeks of coleosoma treatment vs placebo(12 weeks)
- Change from baseline values of HbA1C (%) at 12 weeks of coleosoma treatment vs placebo(12 weeks)
- Change from baseline values of hormone profile (glucagon, active GLP-1 and GIP) at 12 weeks of coleosoma treatment vs placebo(12 weeks)
- change from baseline values of waist circumference (cm) at 12 weeks of coleosoma treatment vs placebo(12 weeks)
- Change from baseline values of ApoB/Apo A1 ratio at 12 weeks of coleosoma treatment vs placebo(12 weeks)
- Change from baseline values of inflammatory cytokines (IL-1, IL6, IL-10, hsPCR, TNFalpha ) at 12 weeks of coleosoma treatment vs placebo(12 weeks)
- Change from baseline values of Endothelial Progenitor Cells (EPC) number at 12 weeks of coleosoma treatment vs placebo(12 weeks)
研究者
Alessandra Dei Cas
Research Assistant, MD, PhD
Azienda Ospedaliero-Universitaria di Parma