InflammationCEAGNCT03906825
Effect of CEAG on Inflammation and Endothelial Function
A study testing CEAG in people with Inflammation and Endothelial Dysfunction, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Endothelial Dysfunction
- What is being tested?
- CEAG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2018to 13 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-75 years
- BP 121-140/81-90 mm Hg on average
- Body Mass Index (BMI) 18-40.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, 90502
About this study
Official title: Acute Effects of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (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.
Read the 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.
- Conditions
- Inflammation, Endothelial Dysfunction
- Being tested
- CEAG, placebo
- Keywords
- Endothelium
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEAGDietary supplement
Curcuminoids, EPA (OMEGA-3), Astaxanthin, GLA
placeboDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| dietary supplement CEAG | Active comparator | The dietary supplements consists of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (CEAG). Receives: Dietary Supplement: CEAG |
| Placebo | Placebo comparator | The Placebo does not contain any CEAG. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in inflammation at 4 weeks
Inflammatory markers IL-6, CRP
Measured: 4 weeks
Secondary outcomes (2)
Rate of change from baseline of endothelial function
endothelial function measured by brachial artery flow mediated dilatation
Measured: 4 weeks
Rate of change in cardio-metabolic relevant biomarkers
Cardio-metabolic relevant biomarkers including fasting Lipids (mg/dL), Glucose (mg/dL)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start17 May 2018
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blind Placebo Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Matthew Budoff, MD, Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906825
- Sponsor's protocol ID
- 22051-01
- Acronym
- CEAG
- Status last verified
- Apr 2020
- First submitted
- 29 Mar 2019
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31987113
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (CEAG) on Inflammation and Endothelial Function
- ClinicalTrials.gov ID
- NCT03906825
- Acronym / sponsor ID
- CEAG / 22051-01
- Conditions
- Inflammation, Endothelial Dysfunction
- Keywords
- Endothelium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double Blind Placebo Controlled
| Arm | Type | Receives |
|---|---|---|
| dietary supplement CEAG | Active comparator | Dietary Supplement: CEAGThe dietary supplements consists of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (CEAG). |
| Placebo | Placebo comparator | Dietary Supplement: placeboThe Placebo does not contain any CEAG. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-75 years
- BP 121-140/81-90 mm Hg on average
- Body Mass Index (BMI) 18-40.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEAGCurcuminoids, EPA (OMEGA-3), Astaxanthin, GLA | Dietary supplement | dietary supplement CEAG |
| placeboplacebo | Dietary supplement | Placebo |
Primary outcome
change from baseline in inflammation at 4 weeks
Time frame: 4 weeks
Inflammatory markers IL-6, CRP
2 secondary outcomes
Rate of change from baseline of endothelial function
Time frame: 4 weeks
Rate of change in cardio-metabolic relevant biomarkers
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Derived from this study: PubMed 31987113Birudaraju 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Budoff, MD principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEAG in people with Inflammation and Endothelial Dysfunction, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in inflammation at 4 weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.