Endothelial Dysfunction, Inflammation
Conditions
Keywords
Endothelium
Brief summary
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.
Detailed description
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.
Interventions
Curcuminoids, EPA (OMEGA-3), Astaxanthin, GLA
placebo
Sponsors
Study design
Intervention model description
Double Blind Placebo Controlled
Eligibility
Inclusion criteria
* age 18-75 years * BP 121-140/81-90 mm Hg on average * Body Mass Index (BMI) 18-40.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in inflammation at 4 weeks | 4 weeks | Inflammatory markers IL-6, CRP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of change from baseline of endothelial function | 4 weeks | endothelial function measured by brachial artery flow mediated dilatation |
| Rate of change in cardio-metabolic relevant biomarkers | 4 weeks | Cardio-metabolic relevant biomarkers including fasting Lipids (mg/dL), Glucose (mg/dL) |
Countries
United States