Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04743050
Status:
UNKNOWN
Last Update Posted:
2021-02-08
First Post:
2021-02-02
Brief Title:
The ALA DHA and EPA Esters in the Prevention of Cardiovascular Diseases
Sponsor:
Wroclaw Medical University
Organization:
Wroclaw Medical University
Study Overview
Official Title:
The Use of Alpha-linolenic ALA Docosahexaenoic DHA and Eicosapanthene EPA Esters in the Prevention of Cardiovascular Diseases in Adults
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OMEGA
Brief Summary:
Essential polyunsaturated fatty acids EFAs have a significant impact on human health even before birth Their supplementation is recommended at all ages especially in people with cardiolovascular risks The most valuable proven action of EFAs is the improvement of the lipid profile including increase in HDL the so-called good cholesterol and lowering LDL the so-called bad cholesterol preventing the development of atherosclerosis strokes and heart attacks
We distinguish three fractions of EFAs EPA DHA and ALA The best known are EPA and DHA but in recent years the interest in ALA fraction has increased as it is the only fraction that has pronounced anti-inflammatory properties but also only ALA is not produced by the human body and must be supplied with food
We believe that the supplementation of the ALA fraction is as important as the supplementation of the well-known and recommended EPA and DHA fractions moreover it also brings unique benefits The aim of the study is to demonstrate the benefits of EFAs in the prevention of cardiovascular diseases in the group of adults In the project we also want to compare the benefits of supplementing various fractions
Each volunteer will be randomly assigned to one of 4 groups Group No 1 will be a group without the supplementation of essential fatty acids EFAs group No 2 will receive supplementation with pure ALA fraction group No 3 will receive supplementation with EPA and DHA fractions and group No 4 will receive supplementation with all fractions ie ALA EPA and DHA All persons from groups 1-4 will be examined three times at the beginning after three months and after six months at the end of the project The tests will include blood pressure measurements non-invasive measurements of body mass and composition and laboratory tests CRP fasting glucose lipid profile and blood count
Both preparations for acid supplementation and tests are completely free for participants
Participation in the study is voluntary and is not associated with any health risk
We distinguish three fractions of EFAs EPA DHA and ALA The best known are EPA and DHA but in recent years the interest in ALA fraction has increased as it is the only fraction that has pronounced anti-inflammatory properties but also only ALA is not produced by the human body and must be supplied with food
We believe that the supplementation of the ALA fraction is as important as the supplementation of the well-known and recommended EPA and DHA fractions moreover it also brings unique benefits The aim of the study is to demonstrate the benefits of EFAs in the prevention of cardiovascular diseases in the group of adults In the project we also want to compare the benefits of supplementing various fractions
Each volunteer will be randomly assigned to one of 4 groups Group No 1 will be a group without the supplementation of essential fatty acids EFAs group No 2 will receive supplementation with pure ALA fraction group No 3 will receive supplementation with EPA and DHA fractions and group No 4 will receive supplementation with all fractions ie ALA EPA and DHA All persons from groups 1-4 will be examined three times at the beginning after three months and after six months at the end of the project The tests will include blood pressure measurements non-invasive measurements of body mass and composition and laboratory tests CRP fasting glucose lipid profile and blood count
Both preparations for acid supplementation and tests are completely free for participants
Participation in the study is voluntary and is not associated with any health risk
Detailed Description:
Supplementation of essential polyunsaturated fatty acids EFAs in patients is recommended by cardiological diabetic hypertensive and gynecological societies The project aims to demonstrate the benefits of following these recommendations in the prevention of cardiovascular diseases in the adult group Most of the research focuses only on EPA and DHA fractions while in view of the publications on the health-promoting properties of the ALA fraction which is the only one that is only exogenous and has clear anti-inflammatory properties in the project we also want to compare the benefits of supplementation of esters of individual EFA fractions We intend to conduct a clinical trial with a control sample and 3 study groups randomly assigned to each group The groups will consist of 50 people which means that the research project will involve 200 people in total The control group will be a group without EFA supplementation the first experimental group will receive supplementation with pure ALA fraction of EFAs esters the second experimental group will receive supplementation of the EPA and DHA fraction of EFAs esters and the third experimental group will receive supplementation of the ALA EPA and DHA fraction of EFAs esters All participants will have laboratory tests marking CRP fasting glucose lipid profile total blood count and additional tests which will include blood pressure measurements and measurements of body mass and composition on a specialized body composition analyzer InBody 270 All the above-mentioned tests will be performed at the time of joining the research program after 3 months in the middle of the research program and after 6 months at the end of the research program
The aim of the study is to determine whether the supplementation of the ALA fraction esters of essential polyunsaturated fatty acids is as important as the supplementation of their EPA and DHA fraction esters and whether it brings additional unique benefits related to its pronounced anti-inflammatory properties This comparison is particularly important in the group of adults as early and effective intervention may contribute to improving health quality of life increasing life expectancy and reducing treatment costs and cardiovascular diseases as lifestyle diseases are one of the most common in the world and concern younger and younger people The projects feasibility is assessed positively as the project has significant scientific potential The discussed topic is up-to-date and the size of the studied group guarantees reliable results and gathering such a group remains possible The importance of using EFAs in medicine is constantly increasing and research using them gives promising results
The aim of the study is to determine whether the supplementation of the ALA fraction esters of essential polyunsaturated fatty acids is as important as the supplementation of their EPA and DHA fraction esters and whether it brings additional unique benefits related to its pronounced anti-inflammatory properties This comparison is particularly important in the group of adults as early and effective intervention may contribute to improving health quality of life increasing life expectancy and reducing treatment costs and cardiovascular diseases as lifestyle diseases are one of the most common in the world and concern younger and younger people The projects feasibility is assessed positively as the project has significant scientific potential The discussed topic is up-to-date and the size of the studied group guarantees reliable results and gathering such a group remains possible The importance of using EFAs in medicine is constantly increasing and research using them gives promising results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None