Acute Effects of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (CEAG) on Inflammation and Endothelial Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- change from baseline in inflammation at 4 weeks
研究概览
简要总结
The purpose of the study is to look at the effect a dietary supplement called CEAG [Curcuminoids, EPA (Omega-3), Astaxanthin and Gamma Linolenic Acid (GLA)] has on inflammation and endothelial (inner layer of the blood vessels) function and whether it causes a lowering of blood pressure.The endothelium plays in an important role in blood pressure.
详细描述
This clinical trial is to assess the efficacy of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA for improving inflammation and endothelial reactivity over a four week intervention period in individuals with metabolic syndrome. The study also examines the effect of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA administration on other markers of cardiovascular function and cardiovascular disease risk including Total, LDL and HDL-Cholesterol, Triglycerides, and a multitude of inflammatory markers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-75 years
- •BP 121-140/81-90 mm Hg on average
- •Body Mass Index (BMI) 18-40.
排除标准
- •free of chronic diseases including cancer or rheumatologic disorders
- •weight in excess of 350 pounds
- •bleeding disorder
- •history of myocardial infarction or all types of revascularization procedures, second or third degree heart block with or without a pacemaker
- •angina pectoris of any type
- •concurrent potentially life-threatening arrhythmia or symptomatic arrhythmia clinically significant valvular heart disease
- •history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, (with the exception of localized basal cell carcinoma of the skin)
- •serum creatinine > 2.0 mg/dl
- •concurrent enrollment in another placebo-controlled trial.
结局指标
主要结局
change from baseline in inflammation at 4 weeks
时间窗: 4 weeks
Inflammatory markers IL-6, CRP
次要结局
- Rate of change from baseline of endothelial function(4 weeks)
- Rate of change in cardio-metabolic relevant biomarkers(4 weeks)
研究者
Matthew J. Budoff
M.D;FACC
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center