Effect of CEAG on Inflammation and Endothelial Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-17

Study Completion Date

2018-08-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inflammation Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double Blind Placebo Controlled

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dietary supplement CEAG

The dietary supplements consists of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (CEAG).

Group Type ACTIVE_COMPARATOR

CEAG

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

The Placebo does not contain any CEAG.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

placebo

Interventions

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CEAG

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

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes