NCT03590496已完成不适用
Safety and Efficacy of PROPionatE for Reduction of LDL Cholesterol (PROPER-LDL Trial) - A Phase 2 Randomized Placebo Controlled Double-blind Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- LDL-cholesterol reduction
研究概览
简要总结
The objective of the trial is to evaluate a potential impact of food supplements with the short chain fatty acid propionate on blood LDL cholesterol level.
详细描述
62 patients with low cardiovascular risk will be 1:1 randomized to receive either placebo (b.i.d.) or 500mg of propionate (b.i.d.). The primary endpoint is the change (delta) in blood LDL cholesterol levels after 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with hypercholestrolemia and a LDL serum level of > 115 mg/dl
- •age of patient between 20 and 70 years
- •participant is fully competent and has given his/her written informed consent to the scheduled trial conduct
排除标准
- •patients with acute coronary syndrome in the last 4 weeks
- •patients with chronic symptomatic heart failure (NYHA 2-4)
- •patients with chronic renal failure and a GFR < 45 ml/min
- •patients with chronic liver disease
- •patients with hematological diseases
- •patients with severe diseases of other organ systems (tumors, infections)
- •pregnancy
研究组 & 干预措施
Arm 1
Active Comparator
31 patients will be treated with 500mg Calcium-Propionate capsules (twice a day) for 8 weeks.
干预措施: Calcium-Propionate 500mg (Dietary Supplement)
Arm 2
Placebo Comparator
31 patients will be treated with placebo capsules (twice a day) for 8 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
LDL-cholesterol reduction
时间窗: 8 weeks
mg/dL
次要结局
- non HDL(8 weeks)
- Ratio HDL/LDL(8 weeks)
- total cholesterol(8 weeks)
- HDL-cholesterol(8 weeks)
研究者
Arash Haghikia
Principal Investigator
Charite University, Berlin, Germany
研究点 (1)
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