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

Wihuri Research Institute

Status: Completed

Conditions: Low-density Lipoproteins Aggregation Susceptibility; Cardiovascular Diseases; Low-density Lipoprotein Lipid Composition; Atherosclerosis

Treatments: Dietary Supplement: Ethyl-Eicosapentaenoic Acid (E-EPA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04152291

E-EPA

Details and patient eligibility

About

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.

Full 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).

Enrollment: 68 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy normolipidemic

Exclusion criteria

• Prescription of blood thinner medicine
• Circulating Low-density lipoprotein > 5mmol/l, Triglycerides >3mmol/l
• Chronic use of pain medication
• Fish allergy
• Pregnancy
• Breastfeeding

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

E-EPA-diet group

Experimental group

Description:

All the study participants will receive the same treatment. 3.9g of E-EPA in capsules, which also include 75µg of D3-vitamin, daily for 28 days.

Treatment:

Dietary Supplement: Ethyl-Eicosapentaenoic Acid (E-EPA)