The Effect of E-EPA on Circulating LDL and Plasma Lipid Metabolism (EPA&LDL)
Primary Purpose
Atherosclerosis, Low-density Lipoproteins Aggregation Susceptibility, Low-density Lipoprotein Lipid Composition
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Ethyl-Eicosapentaenoic Acid (E-EPA)
Sponsored by
About this trial
This is an interventional basic science trial for Atherosclerosis focused on measuring Atherosclerosis, E-EPA, LDL aggregation susceptibility, Lipidomics, Resolvins, PON-1, LCAT, PLTP, CETP, Proteglycan binding
Eligibility Criteria
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
Sites / Locations
- Wihuri Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
E-EPA-diet group
Arm Description
All the study participants will receive the same treatment. 3.9g of E-EPA in capsules, which include 75µg of D3-vitamin, daily for 30 days.
Outcomes
Primary Outcome Measures
LDL Aggregation susceptibility
Lowering in LDL aggregation susceptibility
Lowering total triglycerides
Lowering of total circulating triglycerides
EPA incorporation into LDL
Incorporation of EPA into circulating LDL lipid composition
Secondary Outcome Measures
Increases in EPA mediated resolvins
Increases in circulating resolvins, derived from EPA
Changes in lipid metabolizing enzymes
Changes in activities of circulating lipid metabolizing enzymes such as PON-1, LCAT, PLTP and CETP
Full Information
NCT ID
NCT04152291
First Posted
November 1, 2019
Last Updated
November 15, 2019
Sponsor
Wihuri Research Institute
Collaborators
University of Helsinki, Karolinska Institutet, Minerva Foundation Institute for Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT04152291
Brief Title
The Effect of E-EPA on Circulating LDL and Plasma Lipid Metabolism
Acronym
EPA&LDL
Official Title
The Effect of Ethyl Eicosapentaenoic Acid on Circulating Low-density Lipoproteins and Plasma Lipid Metabolism in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wihuri Research Institute
Collaborators
University of Helsinki, Karolinska Institutet, Minerva Foundation Institute for Medical Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Low-density Lipoproteins Aggregation Susceptibility, Low-density Lipoprotein Lipid Composition, Cardiovascular Diseases
Keywords
Atherosclerosis, E-EPA, LDL aggregation susceptibility, Lipidomics, Resolvins, PON-1, LCAT, PLTP, CETP, Proteglycan binding
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Baseline measurements are compared to different time points during the study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
E-EPA-diet group
Arm Type
Experimental
Arm Description
All the study participants will receive the same treatment. 3.9g of E-EPA in capsules, which include 75µg of D3-vitamin, daily for 30 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ethyl-Eicosapentaenoic Acid (E-EPA)
Other Intervention Name(s)
E-EPA, Icosapentaenoic acid
Intervention Description
3,9 grams of EPA is added to participants' normal diet.
Primary Outcome Measure Information:
Title
LDL Aggregation susceptibility
Description
Lowering in LDL aggregation susceptibility
Time Frame
30 days
Title
Lowering total triglycerides
Description
Lowering of total circulating triglycerides
Time Frame
30 days
Title
EPA incorporation into LDL
Description
Incorporation of EPA into circulating LDL lipid composition
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Increases in EPA mediated resolvins
Description
Increases in circulating resolvins, derived from EPA
Time Frame
30 days
Title
Changes in lipid metabolizing enzymes
Description
Changes in activities of circulating lipid metabolizing enzymes such as PON-1, LCAT, PLTP and CETP
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katariina Öörni, Ph.D
Organizational Affiliation
Wihuri Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wihuri Research Institute
City
Helsinki
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29982602
Citation
Ruuth M, Nguyen SD, Vihervaara T, Hilvo M, Laajala TD, Kondadi PK, Gistera A, Lahteenmaki H, Kittila T, Huusko J, Uusitupa M, Schwab U, Savolainen MJ, Sinisalo J, Lokki ML, Nieminen MS, Jula A, Perola M, Yla-Herttula S, Rudel L, Oorni A, Baumann M, Baruch A, Laaksonen R, Ketelhuth DFJ, Aittokallio T, Jauhiainen M, Kakela R, Boren J, Williams KJ, Kovanen PT, Oorni 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.
Results Reference
background
PubMed Identifier
30415628
Citation
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.
Results Reference
background
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The Effect of E-EPA on Circulating LDL and Plasma Lipid Metabolism
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