Trial Outcomes & Findings for The Effect of E-EPA on Circulating LDL and Plasma Lipid Metabolism (NCT NCT04152291)

Last Updated: 2025-09-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

68 participants

Primary outcome timeframe

28 days

Results posted on

2025-09-22

Participant Flow

Recruitment took place in autumn/winter of 2019/2020 via in-house emailing lists. Participant suitability was assessed prior to the beginning of the supplementation. Healthy normolipidemic individuals aged 18-65 were enrolled.

Participant milestones

Participant milestones
Measure	IPE-supplementation Group All the study participants will receive the same treatment. 3.9g of IPE (Ethyl-EPA) in capsules, which also include 75µg of D3-vitamin, daily for 28 days.
Overall Study STARTED	68
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	IPE-supplementation Group All the study participants will receive the same treatment. 3.9g of IPE (Ethyl-EPA) in capsules, which also include 75µg of D3-vitamin, daily for 28 days.
Overall Study Covid-19 restrictions	27
Overall Study Withdrawal by Subject	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IPE-supplementation Group n=38 Participants All the study participants will receive the same treatment. 3.9g of IPE (Ethyl-EPA) in capsules, which also include 75µg of D3-vitamin, daily for 28 days.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Finland	38 Participants n=5 Participants
LDL-cholesterol	1.7 mmol/L STANDARD_DEVIATION 0.4 • n=5 Participants
Blood triglycerides	0.9 mmol/L STANDARD_DEVIATION 0.4 • n=5 Participants
Body Mass Index (BMI)	23.5 kg/m2 STANDARD_DEVIATION 2.5 • n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	IPE-supplementation Group n=38 Participants All the study participants will receive the same treatment. 3.9g of IPE (Ethyl-EPA) in capsules, which include 75µg of D3-vitamin, daily for 28 days.
LDL Aggregation Susceptibility Baseline	111.3 Minutes Standard Deviation 17.3
LDL Aggregation Susceptibility After 28-day of IPE-supplementation	113.1 Minutes Standard Deviation 25.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	IPE-supplementation Group n=38 Participants All the study participants will receive the same treatment. 3.9g of IPE (Ethyl-EPA) in capsules, which include 75µg of D3-vitamin, daily for 28 days.
Total Blood Triglycerides	-14 percentage of baseline triglycerides Standard Deviation 28

PRIMARY outcome

Timeframe: 28 days

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

Outcome measures

Outcome measures
Measure	IPE-supplementation Group n=38 Participants All the study participants will receive the same treatment. 3.9g of IPE (Ethyl-EPA) in capsules, which include 75µg of D3-vitamin, daily for 28 days.
EPA Incorporation Into LDL After 28-day of IPE-supplementation	0.274 mmol/L Standard Deviation 0.118
EPA Incorporation Into LDL Baseline	0.075 mmol/L Standard Deviation 0.094

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	IPE-supplementation Group n=38 Participants All the study participants will receive the same treatment. 3.9g of IPE (Ethyl-EPA) in capsules, which include 75µg of D3-vitamin, daily for 28 days.
Lipoprotein Retention Baseline	4.995 Bound cholesterol nmol/well Standard Deviation 0.041
Lipoprotein Retention After 28-day of IPE-supplementation	4.428 Bound cholesterol nmol/well Standard Deviation 0.039

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	IPE-supplementation Group n=38 Participants All the study participants will receive the same treatment. 3.9g of IPE (Ethyl-EPA) in capsules, which include 75µg of D3-vitamin, daily for 28 days.
Coronary Event Risk Test 2 Baseline	3.4 Scores on a scale Standard Deviation 2.6
Coronary Event Risk Test 2 After 28-day of IPE-supplementation	2.5 Scores on a scale Standard Deviation 1.8

Adverse Events

IPE-supplementation Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Katariina Öörni

Wihuri Research Institute

Phone: +358 40 7023711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place