Lipid MetabolismPhase 1NCT07304921
Novel Approach to Increase EPA and DHA Levels
A Phase 1 study testing Meldonium + PUFA, PUFA + meldonium and PUFA supplementation only in people with Lipid Metabolism and Omega-3 Polyunsaturated Fatty Acids, run by Riga Stradins University at 1 site in Latvia.
Trial summary
The goal of this intervention trial is to evaluate whether combining meldonium therapy with PUFAs (polyunsaturated fatty acids) supplements containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) changes the plasma (blood component) concentration of EPA and DHA, as well as the acylcarnitine (fatty acid… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism, Omega-3 Polyunsaturated Fatty Acids, Supplementation
- What is being tested?
- Meldonium + PUFA, PUFA + meldonium and PUFA supplementation only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteLatvia
- Study dates
- 6 Apr 2023to 6 Jun 2023
- Phase
- Phase 1
- 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
- Healthy adults (age 18 and older)
Who cannot join
- Previously diagnosed serious chronic diseases (diabetes mellitus, atherosclerotic cardiovascular diseases, chronic kidney and liver diseases, cancer)
- PUFA supplement usage and/or meldonium therapy at least 6 months before inclusion in the study
- Participation in other clinical drug trials
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Intake of Omega-3 Fatty Acids and the Inhibition of Their Mitochondrial Metabolism Increase EPA and DHA Levels in Healthy Volunteers
The goal of this intervention trial is to evaluate whether combining meldonium therapy with PUFAs (polyunsaturated fatty acids) supplements containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) changes the plasma (blood component) concentration of EPA and DHA, as well as the acylcarnitine (fatty acid metabolite) profile in healthy volunteers. The main questions it aims to answer are:
Does using meldonium together with PUFA supplements increase PUFA (EPA and DHA) concentrations in blood plasma? Does meldonium therapy change change the fatty acid metabolite (acylcarnitine) profile, if used together with PUFA supplements?
Read more
Researchers compared plasma metabolic parameters in the beginning, middle and end of study period in a group who received only PUFA supplements, with a group which got PUFA supplements at the beginning, but after one month meldonium therapy was added and a group which got meldonium therapy at the beginning, but after one month PUFA supplements were added.
Participants:
- Received detailed information about the study and signed an informed consent form.
- They were assigned to one of three study groups and received PUFAs and/or meldonium for the duration of the study.
- Plasma samples were collected at the beginning, middle and end of the study period.
- Being tested
- Meldonium + PUFA, PUFA + meldonium, PUFA supplementation only
- Keywords
- PUFA, meldonium, EPA, DHA, cardiometabolic health, acylcarnitines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meldonium + PUFADrug
Meldonium (1g/day) or four weeks, followed by an additional four weeks of combined meldonium and PUFA (930 mg EPA and 750 mg DHA) supplement
PUFA + meldoniumDietary supplement
PUFA supplement (930 mg EPA and 750 mg DHA) for four weeks, followed by an additional four weeks of combined PUFA supplement with 1 g/day meldonium
PUFA supplementation onlyDietary supplement
PUFA supplement containing 930 mg EPA and 750 mg DHA for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: PUFAs supplementation only | Experimental | Participants received only PUFA supplements, metabolic parameters measured in plasma in the beginning, middle and end of study period Receives: Dietary Supplement: PUFA supplementation only |
| Arm 2: PUFAs followed by PUFAs+ meldonium | Experimental | Participants received PUFA supplements at the beginning, but after one month meldonium therapy was added to PUFA supplementation. Metabolic parameters measured in plasma in the beginning, middle and end of study period Receives: Dietary Supplement: PUFA + meldonium |
| Arm 3: Meldonium followed by meldonium+ PUFAs | Experimental | Participants received meldonium therapy at the beginning, but after one month PUFAs supplementation was added to meldonium therapy. Metabolic parameters measured in plasma in the beginning, middle and end of study period Receives: Drug: Meldonium + PUFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the plasma concentrations of EPA and DHA
Measured: From enrollment moment to the end of 8 week study period
Changes in plasma acetylcarnitine concentrations
Acetylcarnitine contains acyl group with 2 carbon atoms
Measured: From the enrollment moment to the end of 8 week study period
Changes in plasma medium-chain acylcarnitine concentration
Medium- chain acylcarnitines are defined as containing acyl groups with 6-12 carbon atoms
Measured: From enrollment moment to the end of 8 week study period
Changes in plasma long-chain acylcarnitine concentration
Long-chain acylcarnitines contain acyl groups with 14-18 carbon atoms
Measured: Time Frame: From the enrollment moment to the end of 8 week study period
Secondary outcomes (2)
Changes in plasma meldonium concentration
Measured: From the enrollment moment to the end of 8 week study period
Changes in plasma gamma-butyrobetaine (GBB) concentrations
Measured: From the enrollment moment to the end of 8 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start6 Apr 2023
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid MetabolismStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riga Stradins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilze Konrade, Riga Stradins University
- Investigators
- Ilze Konrade, PhD, MD, Principal investigator, Riga Stradins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304921
- Sponsor's protocol ID
- VPP-2022/1-000-28/2022
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will deposit individual original measurement results, but not anthropometric data.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intake of Omega-3 Fatty Acids and the Inhibition of Their Mitochondrial Metabolism Increase EPA and DHA Levels in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07304921
- Acronym / sponsor ID
- VPP-2022/1-000-28/2022
- Keywords
- PUFA, meldonium, EPA, DHA, cardiometabolic health, acylcarnitines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Riga Stradins UniversityUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 26 Dec 2025 (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.
The goal of this intervention trial is to evaluate whether combining meldonium therapy with PUFAs (polyunsaturated fatty acids) supplements containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) changes the plasma (blood component) concentration of EPA and DHA, as well as the acylcarnitine (fatty acid metabolite) profile in healthy volunteers. The main questions it aims to answer are:
Does using meldonium together with PUFA supplements increase PUFA (EPA and DHA) concentrations in blood plasma? Does meldonium therapy change change the fatty acid metabolite (acylcarnitine) profile, if used together with PUFA supplements?
Researchers compared plasma metabolic parameters in the beginning, middle and end of study period in a group who received only PUFA supplements, with a group which got PUFA supplements at the beginning, but after one month meldonium therapy was added and a group which got meldonium therapy at the beginning, but after one month PUFA supplements were added.
Participants:
- Received detailed information about the study and signed an informed consent form.
- They were assigned to one of three study groups and received PUFAs and/or meldonium for the duration of the study.
- Plasma samples were collected at the beginning, middle and end of the study period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: PUFAs supplementation only | Experimental | Dietary Supplement: PUFA supplementation onlyParticipants received only PUFA supplements, metabolic parameters measured in plasma in the beginning, middle and end of study period |
| Arm 2: PUFAs followed by PUFAs+ meldonium | Experimental | Dietary Supplement: PUFA + meldoniumParticipants received PUFA supplements at the beginning, but after one month meldonium therapy was added to PUFA supplementation. Metabolic parameters measured in plasma in the beginning, middle and end of study period |
| Arm 3: Meldonium followed by meldonium+ PUFAs | Experimental | Drug: Meldonium + PUFAParticipants received meldonium therapy at the beginning, but after one month PUFAs supplementation was added to meldonium therapy. Metabolic parameters measured in plasma in the beginning, middle and end of study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults (age 18 and older)
Key exclusion criteria (4 listed)
- Previously diagnosed serious chronic diseases (diabetes mellitus, atherosclerotic cardiovascular diseases, chronic kidney and liver diseases, cancer)
- PUFA supplement usage and/or meldonium therapy at least 6 months before inclusion in the study
- Participation in other clinical drug trials
- Pregnancy and breastfeeding
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 |
|---|---|---|
| Meldonium + PUFAMeldonium (1g/day) or four weeks, followed by an additional four weeks of combined meldonium and PUFA (930 mg EPA and 750 mg DHA) supplement | Drug | Arm 3: Meldonium followed by meldonium+ PUFAs |
| PUFA + meldoniumPUFA supplement (930 mg EPA and 750 mg DHA) for four weeks, followed by an additional four weeks of combined PUFA supplement with 1 g/day meldonium | Dietary supplement | Arm 2: PUFAs followed by PUFAs+ meldonium |
| PUFA supplementation onlyPUFA supplement containing 930 mg EPA and 750 mg DHA for 8 weeks | Dietary supplement | Arm 1: PUFAs supplementation only |
Primary outcome
Changes in the plasma concentrations of EPA and DHA
Time frame: From enrollment moment to the end of 8 week study period
Changes in plasma acetylcarnitine concentrations
Time frame: From the enrollment moment to the end of 8 week study period
Acetylcarnitine contains acyl group with 2 carbon atoms
Changes in plasma medium-chain acylcarnitine concentration
Time frame: From enrollment moment to the end of 8 week study period
Medium- chain acylcarnitines are defined as containing acyl groups with 6-12 carbon atoms
Changes in plasma long-chain acylcarnitine concentration
Time frame: Time Frame: From the enrollment moment to the end of 8 week study period
Long-chain acylcarnitines contain acyl groups with 14-18 carbon atoms
2 secondary outcomes
Changes in plasma meldonium concentration
Time frame: From the enrollment moment to the end of 8 week study period
Changes in plasma gamma-butyrobetaine (GBB) concentrations
Time frame: From the enrollment moment to the end of 8 week study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. We will deposit individual original measurement results, but not anthropometric data.
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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.
Ilze Konrade, PhD, MD principal investigator
Riga Stradins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Meldonium + PUFA, PUFA + meldonium and PUFA supplementation only in people with Lipid Metabolism and Omega-3 Polyunsaturated Fatty Acids, run by Riga Stradins University at 1 site in Latvia.
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 4 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: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in the plasma concentrations of EPA and DHA (time frame: From enrollment moment to the end of 8 week study period). The study lists 4 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 31 Jul 2026.