Fatty AcidsPhase 3OMEGANCT04743050
The ALA, DHA and EPA Esters in the Prevention of Cardiovascular Diseases.
A Phase 3 study testing Fatty Acids, Unsaturated and Diagnostic Tests in people with Fatty Acids and Alpha-Linolenic Acid, run by Wroclaw Medical University at 3 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatty Acids, Alpha-Linolenic Acid, Docosahexaenoic Acids
- What is being tested?
- Fatty Acids, Unsaturated and Diagnostic Tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesPoland
- Study dates
- 9 Dec 2020to 30 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults of both sexes in good general condition.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Department of Family Medicine at Wroclaw Medical University
Wroclaw, Dolny Slask, 51-141
Model Practice of a Family Doctor Maria Bujnowska-Fedak
Wroclaw, Dolny Slask, 53-603
TIGmed Private Medical Practice
Wroclaw, Dolny Slask, 53-603
About this study
Official title: The Use of Alpha-linolenic (ALA), Docosahexaenoic (DHA) and Eicosapanthene (EPA) Esters in the Prevention of Cardiovascular Diseases in Adults.
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.
Read more
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.
Read the 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
- Being tested
- Fatty Acids, Unsaturated, Diagnostic Tests
- Keywords
- Essential polyunsaturated fatty acids, EFA, EFAs, ALA, EPA, DHA, Esters
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatty Acids, UnsaturatedDrug
Also called OmegaRegen, Esters of Unsaturated Fatty Acids, EFA
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 TestsDiagnostic test
Also called Laboratory and Additional 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).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control group will be a group without EFA supplementation. Receives: Diagnostic Test: Diagnostic Tests |
| 1st Experimental Group | Experimental | 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. Receives: Drug: Fatty Acids, Unsaturated; Diagnostic Test: Diagnostic Tests |
| 2nd Experimental Group | Experimental | 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. Receives: Drug: Fatty Acids, Unsaturated; Diagnostic Test: Diagnostic Tests |
| 3rd Experimental Group | Experimental | 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. Receives: Drug: Fatty Acids, Unsaturated; Diagnostic Test: Diagnostic Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Better glucose tolerance.
Decrease/normalization in fasting glucose level.
Measured: 6 months
Improvement in lipid metabolism.
Decrease/normalization in lipid profile.
Measured: 6 months
Lowering inflammatory markers.
Decrease of inflammatory markers.
Measured: 6 months
Lowering blood pressure.
Decrease/normalization of blood pressure.
Measured: 6 months
Improving blood count parameters
Normalization of total blood count values.
Measured: 6 months
Lowering body weight.
Decrease of body weight, especially visceral adipose tissue.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start9 Dec 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty AcidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria M Bujnowska-Fedak, MD, PhD, Study director, Departament of Family Medicine at Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743050
- Sponsor's protocol ID
- KB-596/2020
- Acronym
- OMEGA
- Status last verified
- Dec 2020
- First submitted
- 2 Feb 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Alpha-linolenic (ALA), Docosahexaenoic (DHA) and Eicosapanthene (EPA) Esters in the Prevention of Cardiovascular Diseases in Adults.
- ClinicalTrials.gov ID
- NCT04743050
- Acronym / sponsor ID
- OMEGA / KB-596/2020
- Conditions
- Fatty Acids, Alpha-Linolenic Acid, Docosahexaenoic Acids, Eicosapentaenoic Acid, Preventive Health Services, Preventive Medicine
- Keywords
- Essential polyunsaturated fatty acids, EFA, EFAs, ALA, EPA, DHA, Esters
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Diagnostic Test: Diagnostic TestsThe control group will be a group without EFA supplementation. |
| 1st Experimental Group | Experimental | Drug: Fatty Acids, Unsaturated, Diagnostic Test: Diagnostic TestsThe 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. |
| 2nd Experimental Group | Experimental | Drug: Fatty Acids, Unsaturated, Diagnostic Test: Diagnostic TestsThe 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. |
| 3rd Experimental Group | Experimental | Drug: Fatty Acids, Unsaturated, Diagnostic Test: Diagnostic TestsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults of both sexes in good general condition.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatty Acids, UnsaturatedAlso: OmegaRegen, Esters of Unsaturated Fatty Acids, EFAAll 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. | Drug | 1st Experimental Group, 2nd Experimental Group, 3rd Experimental Group |
| Diagnostic TestsAlso: Laboratory and Additional TestsAll 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). | Diagnostic test | 1st Experimental Group, 2nd Experimental Group, 3rd Experimental Group, Control Group |
Primary outcome
Better glucose tolerance.
Time frame: 6 months
Decrease/normalization in fasting glucose level.
Improvement in lipid metabolism.
Time frame: 6 months
Decrease/normalization in lipid profile.
Lowering inflammatory markers.
Time frame: 6 months
Decrease of inflammatory markers.
Lowering blood pressure.
Time frame: 6 months
Decrease/normalization of blood pressure.
Improving blood count parameters
Time frame: 6 months
Normalization of total blood count values.
Lowering body weight.
Time frame: 6 months
Decrease of body weight, especially visceral adipose tissue.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria M Bujnowska-Fedak, MD, PhD study director
Departament of Family Medicine at Wroclaw Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fatty Acids, Unsaturated and Diagnostic Tests in people with Fatty Acids and Alpha-Linolenic Acid, run by Wroclaw Medical University at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Better glucose tolerance. (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.