NCT00764270已完成2 期
The Role of R-alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- hs-CRP
研究概览
简要总结
The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors in people with documented heart disease and increased levels of inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented congestive heart disease (CHD)(defined as at least one significant coronary stenosis > 50% on angiography, or history of documented myocardial infarction)
- •Not diagnosed with unstable angina, uncontrolled hypertension, heart failure, recent myocardial infarction (within last six months)
- •Not taking insulin or oral hypoglycemic agents, anti-inflammatory drugs other than aspirin, or hormone replacement therapy
- •On stable doses for four weeks prior to entry of lipid-lowering therapy (statins), aspirin, and angiotensin-converting enzyme inhibitors or other blood pressure medications. P
- •No tobacco use within 3 months of the study
- •No laboratory evidence of renal, hepatic, or hematological abnormalities
- •Not currently taking vitamin or antioxidant supplements, including R-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the Daily Value (DV) of the vitamins and minerals;
- •Elevated levels of urinary and plasma F2-isoprostanes
- •Elevated plasma levels of hs-CRP
排除标准
- 未提供
研究组 & 干预措施
Lipoic acid treatment
Active Comparator
Participants take lipoic acid with a washout period before or after placebo.
干预措施: R-alpha lipoic acid (Dietary Supplement)
Placebo treatment
Placebo Comparator
Participants take placebo with a washout period before or after lipoic acid treatment
干预措施: R-alpha lipoic acid (Dietary Supplement)
结局指标
主要结局
hs-CRP
时间窗: 12,20 & 32 weeks
High sensitive C-reactive protein
次要结局
- 8-lso-PGF2a(12, 20 & 32 weeks)
研究者
Gerd Bobe
Principal Investigator, Linus Pauling Institute Associate Professor, Department of Animal and Rangeland Sciences
Oregon State University
研究点 (1)
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