drugset / Trial / NCT07304921

Novel Approach to Increase EPA and DHA Levels

NCT07304921

Phase 1 Completed 48 enrolled Riga Stradins University
RandomizedSequentialOpen-labelBasic science

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject DHA Unknown 750 mg
Subject EPA Unknown 930 mg
Subject Meldonium Small molecule 1 g