Effect of CEAG on Inflammation and Endothelial Function

Study Overview
=================
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.

Official Title
-----------------
Acute Effects of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (CEAG) on Inflammation and Endothelial Function

Conditions
-----------------
Inflammation, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Dietary Supplement: CEAG
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double Blind Placebo Controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dietary supplement CEAG<br>The dietary supplements consists of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (CEAG). | Dietary Supplement: CEAG<br>* Curcuminoids, EPA (OMEGA-3), Astaxanthin, GLA<br>|
| Placebo Comparator: Placebo<br>The Placebo does not contain any CEAG. | Dietary Supplement: placebo<br>* placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in inflammation at 4 weeks | Inflammatory markers IL-6, CRP | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change from baseline of endothelial function | endothelial function measured by brachial artery flow mediated dilatation | 4 weeks | 
| Rate of change in cardio-metabolic relevant biomarkers | Cardio-metabolic relevant biomarkers including fasting Lipids (mg/dL), Glucose (mg/dL) | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endothelium