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Novel Approach to Increase EPA and DHA Levels

NCT ID: NCT07304921

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-06

Study Completion Date

2023-06-06

Brief Summary

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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.

Detailed Description

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Conditions

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Lipid Metabolism Omega-3 Polyunsaturated Fatty Acids Supplementation

Keywords

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PUFA meldonium EPA DHA cardiometabolic health acylcarnitines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm 1: PUFAs supplementation only

Participants received only PUFA supplements, metabolic parameters measured in plasma in the beginning, middle and end of study period

Group Type EXPERIMENTAL

PUFA supplementation only

Intervention Type DIETARY_SUPPLEMENT

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

Arm 2: PUFAs followed by PUFAs+ meldonium

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

Group Type EXPERIMENTAL

PUFA + meldonium

Intervention Type 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

Arm 3: Meldonium followed by meldonium+ PUFAs

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

Group Type EXPERIMENTAL

Meldonium + PUFA

Intervention Type 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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DIETARY_SUPPLEMENT

PUFA supplementation only

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Riga Stradins University

OTHER

Sponsor Role lead

Responsible Party

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Ilze Konrade

PhD, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilze Konrade, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Riga Stradins University

Locations

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Riga Stradins university

Riga, , Latvia

Site Status

Countries

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Latvia

Study Documents

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Document Type: Individual Participant Data Set

View Document

Other Identifiers

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VPP-2022/1-000-28/2022

Identifier Type: -

Identifier Source: org_study_id