Novel Approach to Increase EPA and DHA Levels

Riga Stradins University

Status and phase: Completed; Phase 1

Conditions: Supplementation; Lipid Metabolism; Omega-3 Polyunsaturated Fatty Acids

Treatments: Drug: Meldonium + PUFA; Dietary Supplement: PUFA + meldonium; Dietary Supplement: PUFA supplementation only

Study type: Interventional

Funder types: Other

Identifiers

NCT07304921

VPP-2022/1-000-28/2022

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Arm 1: PUFAs supplementation only

Experimental group

Description:

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

Treatment:

Dietary Supplement: PUFA supplementation only

Arm 2: PUFAs followed by PUFAs+ meldonium

Experimental group

Description:

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

Treatment:

Dietary Supplement: PUFA + meldonium

Arm 3: Meldonium followed by meldonium+ PUFAs

Experimental group

Description:

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

Treatment:

Drug: Meldonium + PUFA