Clinical Trials Logo

Clinical Trial 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, i.e. 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.


Clinical Trial 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 project's 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 Design


Related Conditions & MeSH terms


NCT number NCT04743050
Study type Interventional
Source Wroclaw Medical University
Contact
Status Enrolling by invitation
Phase Phase 3
Start date December 9, 2020
Completion date June 30, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Recruiting NCT04417387 - The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
Not yet recruiting NCT06211361 - Cardiac Rehabilitation Program in Patients With Cardiovascular Disease N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04514445 - The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Completed NCT03680638 - The Effect of Antioxidants on Skin Blood Flow During Local Heating Phase 1
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Completed NCT04083846 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed) Phase 1
Completed NCT04083872 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting) Phase 1
Completed NCT03466333 - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia Phase 2
Completed NCT03619148 - The Incidence of Respiratory Symptoms Associated With the Use of HFNO N/A
Completed NCT03693365 - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT05132998 - Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)