Effect of CEAG on Inflammation and Endothelial Function

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Inflammation Endothelial Dysfunction

Interventions

CEAGDIETARY_SUPPLEMENT

Curcuminoids, EPA (OMEGA-3), Astaxanthin, GLA

placeboDIETARY_SUPPLEMENT

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Torrance, California, United States

Outcomes

Primary Outcomes

change from baseline in inflammation at 4 weeks

Inflammatory markers IL-6, CRP

Time frame: 4 weeks

Secondary Outcomes

Rate of change from baseline of endothelial function

endothelial function measured by brachial artery flow mediated dilatation

Time frame: 4 weeks

Rate of change in cardio-metabolic relevant biomarkers

Cardio-metabolic relevant biomarkers including fasting Lipids (mg/dL), Glucose (mg/dL)

Time frame: 4 weeks

Data from ClinicalTrials.gov

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