Effect of a Nutraceutical Combination on Endothelial Injury and C-reactive Protein in Patients With Low-grade Systemic Inflammation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Change from Baseline in LDL cholesterol at 3 months
研究概览
简要总结
The investigators tested if a nutraceutical combination with red yeast rice, berberine and policosanol (NC) can significantly modify inflammation, lipid profile and markers of endothelial injury (endothelial microparticles) in subjects with elevated levels of high-sensitivity C-reactive protein (hsCRP).
详细描述
Will be included in the study 100 subjects with suboptimal LDL cholesterol levels (LDL 100-160 mg / dL) and hsCRP levels> 2 mg / L, divided into two groups of equal numbers, matched by by sex and age, randomized to receive a nutraceutical combination containing red yeast 200 mg, berberine 500 mg and policosanol 10 mg (NC) in combination with a low-cholesterol diet (<200 mg / day) or a low-cholesterol diet only (Standard of Care - SOC).
All subjects at the time of inclusion in the study protocol will be prescribed the SOC for a period of 30 days (Lipid Stabilization Period: LSP); After 30 days LSP it will be performed randomization in the two intervention arms: NC + SOC or SOC.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LDL cholesterol <160 mg/dl (4,14 mmol/l);
- •hsCRP >2 mg/L;
排除标准
- •triglycerides >500 mg/dL (5.6 mmol/L);
- •current or previous treatment with lipid-lowering drugs or with other drugs supposed to modify vascular damage and/or repair (antiplatelet, anti-hypertensive and antioxidant drugs);
- •current or previous treatment with hormone replacement therapy for menopause vasomotor symptoms;
- •evidence of liver dysfunction or alanine-aminotransferase (ALT) levels twice above the upper normal limit;
- •creatin-kinase (CK) levels thrice above the upper normal limit
- •history or clinical evidence of previous or current cardiovascular disease;
- •presence of strong cardiovascular risk factors such as: serum creatinine levels >2 mg/dL, diabetes mellitus, uncontrolled systemic arterial hypertension (systolic blood pressure >190 mg/dL or diastolic blood pressure >100 mg/dL); history of cancer in the former 5 years before recruitment; not adequately treated hypothyroidism (TSH levels >1,5 times the upper normal limit);
- •history of malignancy in the previous 5 years before screening;
- •not adequately treated hypothyroidism (TSH levels >1,5 times the upper normal limit);
- •previous or current alcohol or drugs abuse;
- •history or clinical evidence of chronic inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory bowel disease;
- •current or previous use of immunosuppressant agents or long term glucocorticoids
- •history or clinical evidence of any severe concomitant disease which may compromise subject's safety or its possibility to carry out the study.
结局指标
主要结局
Change from Baseline in LDL cholesterol at 3 months
时间窗: 3 months after treatment randomization
次要结局
- Change from Baseline in C-reactive protein at 3 months(3 months after treatment randomization)
- Change from Baseline in Circulating endothelial microparticles at 3 months(3 months after treatment randomization)
研究者
Matteo Pirro
M.D., PhD
University Of Perugia