Effect of CEAG on Inflammation and Endothelial Function

NCT03906825 | Completed

• 1 other identifier: 22051-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Endothelial Dysfunction

Keywords

Endothelium

Outcome Measures

Primary Outcomes (1)

• change from baseline in inflammation at 4 weeks

  Inflammatory markers IL-6, CRP

  4 weeks

Secondary Outcomes (2)

• Rate of change from baseline of endothelial function

  4 weeks

• Rate of change in cardio-metabolic relevant biomarkers

  4 weeks

Study Arms (2)

dietary supplement CEAG

ACTIVE COMPARATOR

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

Dietary Supplement: CEAG

Placebo

PLACEBO COMPARATOR

The Placebo does not contain any CEAG.

Dietary Supplement: placebo

Interventions

CEAG DIETARY_SUPPLEMENT

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

dietary supplement CEAG

placebo DIETARY_SUPPLEMENT

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-75 years
• BP 121-140/81-90 mm Hg on average
• Body Mass Index (BMI) 18-40.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead

Study Sites (1)

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Torrance, California, 90502, United States

Location

Related Publications (1)

• 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.

  PMID: 31987113 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Budoff, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D;FACC

Model Details: Double Blind Placebo Controlled

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 8, 2019
• Study Start: May 17, 2018
• Primary Completion: August 13, 2018
• Study Completion: August 13, 2018
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

US (1)