NCT01737099已完成不适用
Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia
DSM Nutritional Products, Inc.1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2012年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Change from baseline in TG levels
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of DHA-O to lower elevated triglyceride levels in healthy adults with hypertriglyceridemia.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ages 18-79
- •fasting TG levels, 150-499 mg/dL
- •baseline DHA intake <200mg/d
- •active and in good health
排除标准
- •recent diagnosis of CHD or history of revascularization within 6mos of study
- •use of lipid altering medications (other than stable statins)
- •use of anticoagulants
- •use of omega-3 products within 4 weeks of screening
- •serum AST/ALT >1.5x ULN and/or creatinine >1.5 mg/dL at screening
- •lipid altering foods or supplements
- •women who are pregnant or of childbearing potential not using adequate birth control
- •current use or history of drug or alcohol abuse
- •inability to swallow capsules
研究组 & 干预措施
DHA-O
Experimental
干预措施: DHA-O (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
Fish oil
Active Comparator
干预措施: Fish oil (Dietary Supplement)
结局指标
主要结局
Change from baseline in TG levels
时间窗: week 14
次要结局
- Change from baseline in lipid panel measures(week 14)
研究者
研究点 (1)
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