Effect of CEAG on Inflammation and Endothelial Function

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Status: Completed

Conditions: Inflammation; Endothelial Dysfunction

Treatments: Dietary Supplement: CEAG; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03906825

22051-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

dietary supplement CEAG

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: CEAG

Placebo

Placebo Comparator group

Description:

The Placebo does not contain any CEAG.

Treatment:

Dietary Supplement: placebo