Trials / Completed

CompletedNCT04152291

The Effect of E-EPA on Circulating LDL and Plasma Lipid Metabolism

The Effect of Ethyl Eicosapentaenoic Acid on Circulating Low-density Lipoproteins and Plasma Lipid Metabolism in Healthy Volunteers

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 68 (actual)

Sponsor: Wihuri Research Institute · Academic / Other
Sex: All
Age: 18 Years – 65 Years
Healthy volunteers: Accepted

Summary

40-70 healthy volunteers of ages 18 to 65 participate in a E-EPA-diet where 3,9 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. Eur.H.Journal 2018). Common disease factors such as total cholesterol, LDL, HDL, triglycerides, ApoB-100, ApoA-I, Lp(a) 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. Update at study conclusion 17.6.2025. Covid-19 halted our study progression leading to a partial cohort (final n=38). Covid-19 restrictions also prevented us from measuring plasma lipid metabolism enzymes and lipid mediated resolvins. As a results we expanded the lipoprotein lipidomics analysis to consist all three lipoprotein fractions (VLDL, LDL, and HDL) using LC/MS. Finally a clinical cardiovascular risk score assessment was also performed (CERT2/Hertta-test).

Conditions

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ethyl-Eicosapentaenoic Acid (E-EPA)	3,9 grams of E-EPA (Icosapent ethyl) is added to participants' normal diet.

Timeline

Start date: 2019-11-12
Primary completion: 2024-06-30
Completion: 2024-12-31
First posted: 2019-11-05
Last updated: 2025-09-22
Results posted: 2025-09-22

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT04152291. Inclusion in this directory is not an endorsement.