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Completed

NCT Number: NCT07304921

Novel Approach to Increase EPA and DHA Levels

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:

1. Received detailed information about the study and signed an informed consent form. 2. They were assigned to one of three study groups and received PUFAs and/or meldonium for the duration of the study. 3. Plasma samples were collected at the beginning, middle and end of the study period.

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Key information

Conditions

Lipid Metabolism Omega-3 Polyunsaturated Fatty Acids Supplementation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Riga Stradins university

Riga, Latvia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults (age 18 and older)

Exclusion criteria

  • 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

Treatment and study plan

Meldonium + PUFA

Drug

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 + meldonium

Dietary 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 only

Dietary Supplement

PUFA supplement containing 930 mg EPA and 750 mg DHA for 8 weeks

Primary outcomes

  1. Changes in the plasma concentrations of EPA and DPA

    Time frame: From enrollment moment to the end of 8 week study period

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Changes in plasma meldonium concentration

    Time frame: From the enrollment moment to the end of 8 week study period

  2. Changes in plasma gamma-butyrobetaine (GBB) concentrations

    Time frame: From the enrollment moment to the end of 8 week study period

Sponsors and collaborators

Lead sponsor

Riga Stradins University

Other

Registry information

Official study title

The Intake of Omega-3 Fatty Acids and the Inhibition of Their Mitochondrial Metabolism Increase EPA and DHA Levels in Healthy Volunteers

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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