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Novel Approach to Increase EPA and DHA Levels

NCT07304921 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-26

No results posted yet for this study

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 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.

Conditions

  • Lipid Metabolism
  • Omega-3 Polyunsaturated Fatty Acids
  • Supplementation

Interventions

DIETARY_SUPPLEMENT

PUFA supplementation only

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

DRUG

Meldonium + PUFA

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

DIETARY_SUPPLEMENT

PUFA + meldonium

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

Sponsors & Collaborators

  • Riga Stradins University

    lead OTHER

Principal Investigators

  • Ilze Konrade, PhD, MD · Riga Stradins University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-06
Primary Completion
2023-06-06
Completion
2023-06-06

Countries

  • Latvia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07304921 on ClinicalTrials.gov