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NCT Number: NCT04152291

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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Low-density Lipoprotein Lipid Composition Low-density Lipoproteins Aggregation Susceptibility Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wihuri Research Institute

Helsinki, Finland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ethyl-Eicosapentaenoic Acid (E-EPA)

Dietary Supplement

3,9 grams of E-EPA (Icosapent ethyl) is added to participants' normal diet.

Other names: E-EPA, Icosapent ethyl

Primary outcomes

  1. LDL Aggregation Susceptibility

    Time frame: 28 days

    LDL aggregation susceptibility was induced in vitro by sphingomyelinase and measured using dynamic light scattering. Time-size curves were generated, and the inflection point (EC50)-the midpoint of the most rapid aggregation-was determined by nonlinear regression with a modified Hill equation. A longer time to reach EC50 indicates lower aggregation susceptibility, and thus a lower risk of future cardiovascular events.

  2. Total Blood Triglycerides

    Time frame: 28 days

    Percentage change in blood triglycerides after IPE-supplementation (day 28) compared to the baseline (day 0). Percentage change was calculated as follows: [(day 28 - day 0) / day 0] x 100.

  3. EPA Incorporation Into LDL

    Time frame: 28 days

    Total concentration of eicosapentaenoic acid in LDL lipoprotein fraction at baseline (day 0), and after IPE-supplementation (day 28).

Other outcomes

  1. Lipoprotein Retention

    Time frame: 28 days

    The binding of lipoproteins to aortic proteoglycans, measured ex vivo. At the end of the assay lipoprotein-associated bound cholesterol is measured in each well and compared to control wells to determine the binding probability of LDL particles to aortic proteoglycans.

  2. Coronary Event Risk Test 2

    Time frame: 28 days

    A clinical risk rest used to assess 10-year Coronary event risk. Based on plasma ceramides and phospholipids. Lower risk score indicates smaller future risk of coronary events. The four risk categories are: 0-3 (Low risk), 4-6 (Moderate risk), 7-8 (High risk), and 9-12 (Very high risk).

Sponsors and collaborators

Lead sponsor

Wihuri Research Institute

Other

Collaborators

  • University of Helsinki

Registry information

Official study title

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

Acronym: EPA&LDL

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2019
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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