Lipid Metabolism, Omega-3 Polyunsaturated Fatty Acids, Supplementation
Conditions
Keywords
PUFA, meldonium, EPA, DHA, cardiometabolic health, acylcarnitines
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. 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.
Interventions
DRUGMeldonium + 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_SUPPLEMENTPUFA + 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_SUPPLEMENTPUFA supplementation only
PUFA supplement containing 930 mg EPA and 750 mg DHA for 8 weeks
Sponsors
Riga Stradins University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the plasma concentrations of EPA and DHA | From enrollment moment to the end of 8 week study period | — |
| Changes in plasma acetylcarnitine concentrations | 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 | 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: From the enrollment moment to the end of 8 week study period | Long-chain acylcarnitines contain acyl groups with 14-18 carbon atoms |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Latvia
Contacts
PRINCIPAL_INVESTIGATORIlze Konrade, PhD, MD
Riga Stradins University
Outcome results
None listed