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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilze Konrade, PhD, MD | Riga Stradins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riga Stradins university | Riga | Latvia |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
We will deposit individual original measurement results, but not anthropometric data.
Available immediately following completion of the study. Study data will be stored indefinitely in accordance with institutional and regulatory requirements
Data will be provided to researchers on request. We will evaluate whether their purpose comply with the consent and ethics approval.
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| ID | Term |
|---|---|
| C050147 | 3-(2,2,2-trimethylhydrazine)propionate |
| D005231 | Fatty Acids, Unsaturated |
| ID | Term |
|---|---|
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| 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 |
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| PUFA supplementation only | Dietary Supplement | PUFA supplement containing 930 mg EPA and 750 mg DHA for 8 weeks |
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