NCT07304921

Novel Approach to Increase EPA and DHA Levels

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Riga Stradins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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
DIETARY_SUPPLEMENT	PUFA supplementation only	PUFA supplement containing 930 mg EPA and 750 mg DHA for 8 weeks

Timeline

• Start date: 2023-04-06
• Primary completion: 2023-06-06
• Completion: 2023-06-06
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: Latvia