Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04743050 |
| Other study ID # |
KB-596/2020 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
December 9, 2020 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
December 2020 |
| Source |
Wroclaw Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
