Efficacy of Red Yeast Rice Based Nutraceutical (Monacolin K 10 mg/Dose) Plus Probiotic (Bifidobacterium Longum BB536 ®) in Patients With Moderate Hypercholesterolemia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Percent Change in LDL-C From Baseline
研究概览
简要总结
A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium longum BB536 ®), versus placebo, in patients with moderate hypercholesterolemia, in terms of improvement of the lipid profile and cardiovascular risk.
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)
盲法说明
Double-blind (subjects, investigators)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 ≤ men or women ≤ 70
- •men or female. Female must be postmenopausal or surgically sterile
- •130 mg/dl ≤ LDL-C ≤ 200 mg/dl
- •patients in primary cardiovascular prevention
排除标准
- •pregnancy and lactating
- •patients with chronic diseases
- •patients with serious hepatic diseases
- •patients with serious renal diseases
- •patients with thyroid diseases
- •diabetes mellitus or glycemia >126 mg/dl
- •uncontrolled or severe hypertension
- •obesity(BMI>30)
- •smoking status
- •drug or nutraceutical that can interfere with the experimental treatment
研究组 & 干预措施
Lactoflorene colesterolo
Red Yeast Rice titrated in 10 mg monacolin K per daily dose plus Bifidobacterium longum 50 mg, powder form, 1 packet per day
干预措施: Lactoflorene colesterolo (Dietary Supplement)
Placebo Lactoflorene colesterolo
placebo, powder form, 1 packet per day
干预措施: Placebo lactoflorene colesterolo (Dietary Supplement)
结局指标
主要结局
Percent Change in LDL-C From Baseline
时间窗: 12 weeks
Percent change from baseline in LDL-C after 12 weeks of treatment in patients with moderate hypercholesterolemia
次要结局
- Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins(12 weeks)
- Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events)(12 weeks)
- Changes in Vital Signs(12 weeks)