Clinical trial NCT04743050: The ALA, DHA and EPA Esters in the Prevention of Cardiovascular Diseases.
Official title: The Use of Alpha-linolenic (ALA), Docosahexaenoic (DHA) and Eicosapanthene (EPA) Esters in the Prevention of Cardiovascular Diseases in Adults.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fatty Acids
Alpha-Linolenic Acid
Docosahexaenoic Acids
Eicosapentaenoic Acid
Preventive Health Services
Preventive Medicine
Cardiovascular Diseases
Anti-Inflammatory Agents
Keywords: Essential polyunsaturated fatty acids
EFA
EFAs
ALA
EPA
DHA
Esters
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Better glucose tolerance.
timeFrame: 6 months
measure: Improvement in lipid metabolism.
timeFrame: 6 months
measure: Lowering inflammatory markers.
timeFrame: 6 months
measure: Lowering blood pressure.
timeFrame: 6 months
measure: Improving blood count parameters
timeFrame: 6 months
measure: Lowering body weight.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Department of Family Medicine at Wroclaw Medical University
state: Dolny Slask
city: Wroclaw
country: Poland
facility: Model Practice of a Family Doctor Maria Bujnowska-Fedak
state: Dolny Slask
city: Wroclaw
country: Poland
facility: TIGmed Private Medical Practice
state: Dolny Slask
Study officials:
affiliation: Departament of Family Medicine at Wroclaw Medical University
name: Maria M Bujnowska-Fedak, MD, PhD
role: STUDY_DIRECTOR
References: