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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dietary supplement CEAG | Active Comparator | The dietary supplements consists of Curcuminoids, EPA (Omega-3), Astaxanthin and GLA (CEAG). |
|
| Placebo | Placebo Comparator | The Placebo does not contain any CEAG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEAG | Dietary Supplement | Curcuminoids, EPA (OMEGA-3), Astaxanthin, GLA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in inflammation at 4 weeks | Inflammatory markers IL-6, CRP | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of change from baseline of endothelial function | endothelial function measured by brachial artery flow mediated dilatation | 4 weeks |
| Rate of change in cardio-metabolic relevant biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Budoff, MD | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center | Torrance | California | 90502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31987113 | Derived | 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. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Double Blind Placebo Controlled
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| placebo |
| Dietary Supplement |
placebo |
|
Cardio-metabolic relevant biomarkers including fasting Lipids (mg/dL), Glucose (mg/dL)
| 4 weeks |