The Intake of Omega-3 Fatty Acids and the Inhibition of Their Mitochondrial Metabolism Increase EPA and DHA Levels in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Riga Stradins University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Changes in the plasma concentrations of EPA and DHA
Study Overview
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:
- Received detailed information about the study and signed an informed consent form.
- They were assigned to one of three study groups and received PUFAs and/or meldonium for the duration of the study.
- Plasma samples were collected at the beginning, middle and end of the study period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Arm 1: PUFAs supplementation only
Participants received only PUFA supplements, metabolic parameters measured in plasma in the beginning, middle and end of study period
Intervention: PUFA supplementation only (Dietary Supplement)
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
Intervention: PUFA + meldonium (Dietary Supplement)
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
Intervention: Meldonium + PUFA (Drug)
Outcomes
Primary Outcomes
Changes in the plasma concentrations of EPA and DHA
Time Frame: From enrollment moment to the end of 8 week study period
Changes in the plasma concentrations of EPA and DPA
Time Frame: From enrollment moment to the end of 8 week study period
Changes in plasma acetylcarnitine concentrations
Time Frame: From the enrollment moment to the end of 8 week study period
Acetylcarnitine contains acyl group with 2 carbon atoms
Changes in plasma medium-chain acylcarnitine concentration
Time Frame: From enrollment moment to the end of 8 week study period
Medium- chain acylcarnitines are defined as containing acyl groups with 6-12 carbon atoms
Changes in plasma long-chain acylcarnitine concentration
Time Frame: Time Frame: From the enrollment moment to the end of 8 week study period
Long-chain acylcarnitines contain acyl groups with 14-18 carbon atoms
Secondary Outcomes
- 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)
Investigators
Ilze Konrade
PhD, MD
Riga Stradins University