Ignite Creation Date:
2024-05-06 @ 1:54 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04152291
Status:
UNKNOWN
Last Update Posted:
2019-11-18
First Post:
2019-11-01
Brief Title:
The Effect of E-EPA on Circulating LDL and Plasma Lipid Metabolism
Sponsor:
Wihuri Research Institute
Organization:
Wihuri Research Institute
Study Overview
Official Title:
The Effect of Ethyl Eicosapentaenoic Acid on Circulating Low-density Lipoproteins and Plasma Lipid Metabolism in Healthy Volunteers
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
EPALDL
Brief Summary:
40-70 healthy volunteers of ages 18 to 65 participate in a E-EPA-diet where 39 grams of E-EPA is added to their normal diet and lifestyles for a month Blood samples will be collected before the study and at weeks 1 and 4 and also two weeks after finishing the diet Main study focuses are LDL aggregation susceptibility lipid composition and proteoglycan binding affinity In addition important plasma lipid metabolism enzymes and lipid mediated resolvins are measured as well as several baseline characteristics
Detailed Description:
Four grams of daily E-EPA was found to significantly decrease atherosclerotic cardiovascular diseases in the REDUCE-IT study In the upcoming study the effect of E-EPA to low-density lipoprotein LDL aggregation susceptibility is measured using dynamic light scattering technique to continuously measure particles size while inducing aggregation LDL Lipid composition is analyzed using electrospray mass spectrometer optimized for lipid measurements Previously is reported that the aggregation susceptibility is affected by the lipid composition which is modifiable Ruuth et al EurHJournal 2018 Common disease factors such as total cholesterol LDL HDL triglyserides ApoB-100 ApoA-I Lpa and different modified LDL levels are measured Also activities of lipid metabolism enzymes like PON-1 LCAT CETP PLTP and lipid mediated resolvins are looked into Objective is to identify changes and possible pathways that are altered by the increase of E-EPA and to use the data to possibly explain the health benefits of EPA
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?:
None
Is an FDA AA801 Violation?:
None