NCT02215694已完成3 期
Supplementation of Dual Probiotic Strains, Lactobacillus Curvatus HY7601 and Lactobacillus Plantarum KY1032, Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels in Nondiabetic and Hypertriglyceridemic Subjects
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- ApoA5-1131 genotype
研究概览
简要总结
The purpose of this study is to evaluate the effect of dual probiotic strains containing Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on triglyceride and apolipoprotein A-V.
详细描述
A randomized, double-blind, placebo-controlled study was conducted on 128 nondiabetic and hypertriglyceridemic (Plasma Triglyceride, 150-500 mg/dL) subjects. Over a 12 week test period, the probiotic group consumed 2g of powder daily containing dual probiotic strains, while the placebo group consumed the same without probiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 24 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •nondiabetic (plasma fasting glucose, <126mg/dL; 2-hour plasma glucose, <200mg/dL)
- •borderline to moderate hypertriglyceridemia (plasma triglyceride, 150-500 mg/dL)
排除标准
- •lipid-lowering medications use
- •any medications or supplement use
- •any probiotics products use for the past 1 months
- •dyslipidemia
- •diabetes mellitus
- •hypertension
- •liver disease
- •renal disease
- •cardiovascular disease
- •cerebrovascular disease
- •pancreatitis
- •medication or alcohol abuse
- •pregnant or breast feeding
结局指标
主要结局
ApoA5-1131 genotype
时间窗: at baseline
ApoA5-1131 T\>C
次要结局
- Fasting glucose at baseline and 12-week follow-up(12-week follow-up)
- Apolipoprotein A-V at baseline and 12-week follow-up(12-week follow-up)
- C-peptide at baseline and 12-week follow-up(12-week follow-up)
- Free fatty acid at baseline and 12-week follow-up(12-week follow-up)
- Insulin at baseline and 12-week follow-up(12-week follow-up)
- Triglyceride at baseline and 12-week follow-up(12-week follow-up)
研究者
研究点 (2)
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