Effect of CEAG on Inflammation and Endothelial Function

Not Applicable

Completed

• Conditions: Inflammation; Endothelial Dysfunction
• Interventions: Dietary Supplement: placebo; Dietary Supplement: CEAG

• Registration Number: NCT03906825
• Lead Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

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.

Study Timeline

• Study Start: 2018-05-17
• Primary Completion: 2018-08-13
• Study Completion: 2018-08-13
• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	The Placebo does not contain any CEAG.
dietary supplement CEAG	CEAG	The dietary supplements consists of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (CEAG).

Primary Outcome Measures

Name	Time	Method
change from baseline in inflammation at 4 weeks	4 weeks	Inflammatory markers IL-6, CRP

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center; 🇺🇸 Torrance, California, United States