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Effect of CEAG on Inflammation and Endothelial Function

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03906825
Acronym
CEAG
Enrollment
80
Registered
2019-04-08
Start date
2018-05-17
Completion date
2018-08-13
Last updated
2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Inflammation

Keywords

Endothelium

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.

Interventions

DIETARY_SUPPLEMENTCEAG

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

DIETARY_SUPPLEMENTplacebo

placebo

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Double Blind Placebo Controlled

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
change from baseline in inflammation at 4 weeks4 weeksInflammatory markers IL-6, CRP

Secondary

MeasureTime frameDescription
Rate of change from baseline of endothelial function4 weeksendothelial function measured by brachial artery flow mediated dilatation
Rate of change in cardio-metabolic relevant biomarkers4 weeksCardio-metabolic relevant biomarkers including fasting Lipids (mg/dL), Glucose (mg/dL)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026