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.
研究组 & 干预措施
Standard of Care + Placebo
low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + once daily placebo
干预措施: Placebo (Other)
Standard of Care + Placebo
low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + once daily placebo
干预措施: Standard of Care (Other)
Nutraceutical combination
low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + Nutraceutical combination
干预措施: Nutraceutical Combination (Dietary Supplement)
Nutraceutical combination
low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + Nutraceutical combination
干预措施: Standard of Care (Other)
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