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Completed

NCT Number: NCT03906825

Effect of CEAG on Inflammation and Endothelial Function

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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Key information

Conditions

Inflammation Endothelial Dysfunction Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Torrance, California, 90502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CEAG

Dietary Supplement

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

Placebo

Dietary Supplement

placebo

Primary outcomes

  1. change from baseline in inflammation at 4 weeks

    Time frame: 4 weeks

    Inflammatory markers IL-6, CRP

Secondary outcomes

  1. Rate of change from baseline of endothelial function

    Time frame: 4 weeks

    endothelial function measured by brachial artery flow mediated dilatation

  2. Rate of change in cardio-metabolic relevant biomarkers

    Time frame: 4 weeks

    Cardio-metabolic relevant biomarkers including fasting Lipids (mg/dL), Glucose (mg/dL)

Sponsors and collaborators

Lead sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Other

Registry information

Official study title

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

Acronym: CEAG

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 8, 2019
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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