Effect of CEAG on Inflammation and Endothelial Function

Inflammation Clinical Trial

— CEAG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906825
• Other study ID #: 22051-01
• Status: Completed
• Phase: N/A
• Start date: May 17, 2018
• Est. completion date: August 13, 2018

Study information

• Verified date: April 2020
• Source: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 13, 2018
• Est. primary completion date: August 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Inflammation

Intervention

Dietary Supplement:
• CEAG
Curcuminoids, EPA (OMEGA-3), Astaxanthin, GLA
• placebo
placebo

Locations

Country	Name	City	State
United States	Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in inflammation at 4 weeks	Inflammatory markers IL-6, CRP	4 weeks
Secondary	Rate of change from baseline of endothelial function	endothelial function measured by brachial artery flow mediated dilatation	4 weeks
Secondary	Rate of change in cardio-metabolic relevant biomarkers	Cardio-metabolic relevant biomarkers including fasting Lipids (mg/dL), Glucose (mg/dL)	4 weeks