The Intake of Omega-3 Fatty Acids and the Inhibition of Their Mitochondrial Metabolism Increase EPA and DHA Levels in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Changes in the plasma concentrations of EPA and DHA
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults (age 18 and older)
排除标准
- •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
研究组 & 干预措施
Arm 1: PUFAs supplementation only
Participants received only PUFA supplements, metabolic parameters measured in plasma in the beginning, middle and end of study period
干预措施: 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
干预措施: 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
干预措施: Meldonium + PUFA (Drug)
结局指标
主要结局
Changes in the plasma concentrations of EPA and DHA
时间窗: From enrollment moment to the end of 8 week study period
Changes in the plasma concentrations of EPA and DPA
时间窗: From enrollment moment to the end of 8 week study period
Changes in plasma acetylcarnitine concentrations
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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)
研究者
Ilze Konrade
PhD, MD
Riga Stradins University