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

Cardiovascular Diseases Clinical Trial

— EPA&LDL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04152291
• Other study ID #: E-EPA
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2019
• Source: Wihuri Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, triglyserides, 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Disease Susceptibility
• Low-density Lipoprotein Lipid Composition
• Low-density Lipoproteins Aggregation Susceptibility

Intervention

Dietary Supplement:
• Ethyl-Eicosapentaenoic Acid (E-EPA)
3,9 grams of EPA is added to participants' normal diet.

Locations

Country	Name	City	State
Finland	Wihuri Research Institute	Helsinki

Sponsors (4)

Lead Sponsor	Collaborator
Wihuri Research Institute	Helsinki University, Karolinska Institutet, Minerva Foundation Institute for Medical Research

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. doi: 10.1056/NEJMoa1812792. Epub 2018 Nov 10. — View Citation

Ruuth M, Nguyen SD, Vihervaara T, Hilvo M, Laajala TD, Kondadi PK, Gisterå A, Lähteenmäki H, Kittilä T, Huusko J, Uusitupa M, Schwab U, Savolainen MJ, Sinisalo J, Lokki ML, Nieminen MS, Jula A, Perola M, Ylä-Herttula S, Rudel L, Öörni A, Baumann M, Baruch A, Laaksonen R, Ketelhuth DFJ, Aittokallio T, Jauhiainen M, Käkelä R, Borén J, Williams KJ, Kovanen PT, Öörni K. Susceptibility of low-density lipoprotein particles to aggregate depends on particle lipidome, is modifiable, and associates with future cardiovascular deaths. Eur Heart J. 2018 Jul 14;39(27):2562-2573. doi: 10.1093/eurheartj/ehy319. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL Aggregation susceptibility	Lowering in LDL aggregation susceptibility	30 days
Primary	Lowering total triglycerides	Lowering of total circulating triglycerides	30 days
Primary	EPA incorporation into LDL	Incorporation of EPA into circulating LDL lipid composition	30 days
Secondary	Increases in EPA mediated resolvins	Increases in circulating resolvins, derived from EPA	30 days
Secondary	Changes in lipid metabolizing enzymes	Changes in activities of circulating lipid metabolizing enzymes such as PON-1, LCAT, PLTP and CETP	30 days