Clinical trial NCT03906825: Effect of CEAG on Inflammation and Endothelial Function
Official title: Acute Effects of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (CEAG) on Inflammation and Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Endothelial Dysfunction
Keywords: Endothelium
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blind Placebo Controlled
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change from baseline in inflammation at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Rate of change from baseline of endothelial function
timeFrame: 4 weeks
measure: Rate of change in cardio-metabolic relevant biomarkers
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
state: California
Study officials:
affiliation: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: Matthew Budoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Birudaraju D, Cherukuri L, Kinninger A, Chaganti BT, Shaikh K, Hamal S, Flores F, Roy SK, Budoff MJ. A combined effect of Cavacurcumin, Eicosapentaenoic acid (Omega-3s), Astaxanthin and Gamma -linoleic acid (Omega-6) (CEAG) in healthy volunteers- a randomized, double-blind, placebo-controlled study. Clin Nutr ESPEN. 2020 Feb;35:174-179. doi: 10.1016/j.clnesp.2019.09.011. Epub 2019 Oct 24.