Novel Approach to Increase EPA and DHA Levels

NCT07304921 | Completed Phase 1

• 1 other identifier: VPP-2022/1-000-28/2022
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 1.Received detailed information about the study and signed an informed consent form.
2. 2.They were assigned to one of three study groups and received PUFAs and/or meldonium for the duration of the study.
3. 3.Plasma samples were collected at the beginning, middle and end of the study period.

Conditions

Lipid Metabolism; Omega-3 Polyunsaturated Fatty Acids; Supplementation

Keywords

PUFA; meldonium; EPA; DHA; cardiometabolic health; acylcarnitines

Outcome Measures

Primary Outcomes (4)

• Changes in the plasma concentrations of EPA and DPA

  From enrollment moment to the end of 8 week study period

• Changes in plasma acetylcarnitine concentrations

  Acetylcarnitine contains acyl group with 2 carbon atoms

  From the enrollment moment to the end of 8 week study period

• Changes in plasma medium-chain acylcarnitine concentration

  Medium- chain acylcarnitines are defined as containing acyl groups with 6-12 carbon atoms

  From enrollment moment to the end of 8 week study period

• Changes in plasma long-chain acylcarnitine concentration

  Long-chain acylcarnitines contain acyl groups with 14-18 carbon atoms

  Time Frame: From the enrollment moment to the end of 8 week study period

Secondary Outcomes (2)

• Changes in plasma meldonium concentration

  From the enrollment moment to the end of 8 week study period

• Changes in plasma gamma-butyrobetaine (GBB) concentrations

  From the enrollment moment to the end of 8 week study period

Study Arms (3)

Arm 1: PUFAs supplementation only

EXPERIMENTAL

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

Dietary Supplement: PUFA supplementation only

Arm 2: PUFAs followed by PUFAs+ meldonium

EXPERIMENTAL

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

Dietary Supplement: PUFA + meldonium

Arm 3: Meldonium followed by meldonium+ PUFAs

EXPERIMENTAL

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

Drug: Meldonium + PUFA

Interventions

Meldonium + PUFA 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

Arm 3: Meldonium followed by meldonium+ PUFAs

PUFA + meldonium 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 2: PUFAs followed by PUFAs+ meldonium

PUFA supplementation only DIETARY_SUPPLEMENT

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

Arm 1: PUFAs supplementation only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults (age 18 and older)

You may not qualify if:

• Previously diagnosed serious chronic diseases (diabetes mellitus, atherosclerotic cardiovascular diseases, chronic kidney and liver diseases, cancer)
• Participation in other clinical drug trials
• Pregnancy and breastfeeding

Sponsors & Collaborators

• Riga Stradins University: lead

Study Sites (1)

Riga Stradins university

Riga, Latvia

Location

MeSH Terms

Interventions

3-(2,2,2-trimethylhydrazine)propionate; Fatty Acids, Unsaturated

Intervention Hierarchy (Ancestors)

Fatty Acids; Lipids

Study Officials

• Ilze Konrade, PhD, MD

  Riga Stradins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 26, 2025
• Study Start: April 6, 2023
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available immediately following completion of the study. Study data will be stored indefinitely in accordance with institutional and regulatory requirements
• Access Criteria: Data will be provided to researchers on request. We will evaluate whether their purpose comply with the consent and ethics approval.

Locations

LA (1)