Ignite Creation Date:
2024-07-17 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494488
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Differential Thrombogenesis Effects of Eicosapentaenoic Acid EPA and Docosahexaenoic Acid DHA Mediated by High-Density Lipoprotein HDL
Sponsor:
The Miriam Hospital
Organization:
The Miriam Hospital
Study Overview
Official Title:
Differential Thrombogenesis Effects of EPA and DHA Mediated by HDL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Epidemiological studies suggest that consumption of omega-3 polyunsaturated fatty acids n-3 PUFAs derived from fish oil mainly consisting of eicosapentaenoic acid EPA and docosahexaenoic acid DHA is associated with lower cardiovascular risk However interventional clinical trials aimed at reducing cardiovascular incidents by n-3 PUFAs supplementations have yielded inconsistent results An intriguing fact is that only the outcome trials using EPA but not those testing EPADHA mixed regimens showed beneficial results This discrepancy begs the question of whether EPA and DHA have differential effects and whether DHA blunts the cardiovascular benefits of EPA However no head-to-head clinical trial comparison of the biological effects of EPA and DHA in the hyperlipidemia patients has been reported Hence a well-designed controlled proof-of-concept clinical study testing EPA versus DHA in a relevant population is urgently required In this study the human subjects with atherogenic dyslipidemia will be randomized to dietary supplementation with four grams of either EPA or DHA n-3 PUFAs for eight weeks At baseline and after the supplementation various markers of thrombogenesis will be assessed including biomarkers of the clotting cascade thromboelastography urinary thromboxane metabolites whole blood aggregation platelet aggregation and flow cytometry analysis of platelets and platelet-leukocyte aggregates will also be performed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None