The ALA, DHA and EPA Esters in the Prevention of Cardiovascular Diseases.

NCT ID: NCT04743050

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2022-06-30

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, 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.

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 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.

Conditions

Fatty Acids; Alpha-Linolenic Acid; Docosahexaenoic Acids; Eicosapentaenoic Acid; Preventive Health Services; Preventive Medicine; Cardiovascular Diseases; Anti-Inflammatory Agents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group

The control group will be a group without EFA supplementation.

Group Type: ACTIVE_COMPARATOR

Diagnostic Tests

Intervention Type: DIAGNOSTIC_TEST

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 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).

1st Experimental Group

The first experimental group will receive supplementation with pure ALA fraction of EFA esters. 5 ml a day of OmegaRegen Original containing 2.9 g of ALA, 0.9 g of oleic acid and 0.8 g of linoleic acid for six months.

Group Type: EXPERIMENTAL

Fatty Acids, Unsaturated

Intervention Type: DRUG

All participants from Experimental Groups will receive supplementation of different fractions of EFAs esters for six months daily. Control Group will be monitored with the same tests, but will not receive any supplementation.

Diagnostic Tests

Intervention Type: DIAGNOSTIC_TEST

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 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).

2nd Experimental Group

The second test group will receive supplementation of the EPA and DHA fraction of EFA esters. 5 ml a day of OmegaRegen EPA+DHA containing 0.032 g of EPA, 0.192 g of DHA, 0.9 g of oleic acid and 0.8 g of linoleic acid for six months.

Group Type: EXPERIMENTAL

Fatty Acids, Unsaturated

Intervention Type: DRUG

All participants from Experimental Groups will receive supplementation of different fractions of EFAs esters for six months daily. Control Group will be monitored with the same tests, but will not receive any supplementation.

Diagnostic Tests

Intervention Type: DIAGNOSTIC_TEST

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 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).

3rd Experimental Group

The second test group will receive supplementation of the EPA and DHA fraction of EFA esters. 5 ml a day of OmegaRegen MAMA containing 2.9 g of ALA, 0.032 g of EPA, 0.192 g of DHA, 0.9 g of oleic acid and 0.8 g of linoleic acid for six months.

Group Type: EXPERIMENTAL

Fatty Acids, Unsaturated

Intervention Type: DRUG

All participants from Experimental Groups will receive supplementation of different fractions of EFAs esters for six months daily. Control Group will be monitored with the same tests, but will not receive any supplementation.

Diagnostic Tests

Intervention Type: DIAGNOSTIC_TEST

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 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).

Interventions

Fatty Acids, Unsaturated

All participants from Experimental Groups will receive supplementation of different fractions of EFAs esters for six months daily. Control Group will be monitored with the same tests, but will not receive any supplementation.

Intervention Type: DRUG

Diagnostic Tests

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 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).

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

OmegaRegen; Esters of Unsaturated Fatty Acids; EFA; Laboratory and Additional Tests

Eligibility Criteria

Inclusion Criteria

• adults of both sexes in good general condition.

Exclusion Criteria

• pregnancy, acute diseases or uncontrolled / unchecked chronic diseases, indications for absolute treatment with lipid-lowering drugs or its modification, insulin-dependent diabetes mellitus, liver diseases, use of warfarin or heparin.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wroclaw Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria M Bujnowska-Fedak, MD, PhD

Role: STUDY_DIRECTOR

Departament of Family Medicine at Wroclaw Medical University

Locations

Department of Family Medicine at Wroclaw Medical University

Wroclaw, Dolny Slask, Poland

Model Practice of a Family Doctor Maria Bujnowska-Fedak

Wroclaw, Dolny Slask, Poland

TIGmed Private Medical Practice

Wroclaw, Dolny Slask, Poland

Countries

Poland

Other Identifiers

KB-596/2020

Identifier Type: -

Identifier Source: org_study_id