search
Back to results

Effect of CEAG on Inflammation and Endothelial Function (CEAG)

Primary Purpose

Inflammation, Endothelial Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CEAG
placebo
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation focused on measuring Endothelium

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

dietary supplement CEAG

Placebo

Arm Description

The dietary supplements consists of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (CEAG).

The Placebo does not contain any CEAG.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 29, 2019
Last Updated
April 7, 2020
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03906825
Brief Title
Effect of CEAG on Inflammation and Endothelial Function
Acronym
CEAG
Official Title
Acute Effects of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (CEAG) on Inflammation and Endothelial Function
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
August 13, 2018 (Actual)
Study Completion Date
August 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Endothelial Dysfunction
Keywords
Endothelium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double Blind Placebo Controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dietary supplement CEAG
Arm Type
Active Comparator
Arm Description
The dietary supplements consists of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (CEAG).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The Placebo does not contain any CEAG.
Intervention Type
Dietary Supplement
Intervention Name(s)
CEAG
Intervention Description
Curcuminoids, EPA (OMEGA-3), Astaxanthin, GLA
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
change from baseline in inflammation at 4 weeks
Description
Inflammatory markers IL-6, CRP
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Rate of change from baseline of endothelial function
Description
endothelial function measured by brachial artery flow mediated dilatation
Time Frame
4 weeks
Title
Rate of change in cardio-metabolic relevant biomarkers
Description
Cardio-metabolic relevant biomarkers including fasting Lipids (mg/dL), Glucose (mg/dL)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Budoff, MD
Organizational Affiliation
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31987113
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.
Results Reference
derived

Learn more about this trial

Effect of CEAG on Inflammation and Endothelial Function

We'll reach out to this number within 24 hrs