Hydroxytyrosol Bioavailability in Humans: A Comparative Study of Three EPA-Enriched Formulations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Targeted and untargeted metabolomics
研究概览
简要总结
The primary objective of this study is to evaluate the optimal formulation of a natural nutraceutical whose daily consumption at nutritional doses may confer benefits for cardiovascular health. This nutraceutical combines an omega-3 fatty acid (eicosapentaenoic acid, EPA) with hydroxytyrosol (a potent antioxidant found in olives and extra virgin olive oil). The study will allow to compare how and to what extent hydroxytyrosol is absorbed when co-administered the omega-3 fatty acid in capsules across three different formulations.
详细描述
12 healthy male and female participants will consume various formulations corresponding to three nutraceuticals developed: hydroxytyrosol acetate (HT-Ac), hydroxytyrosol eicosapentanoate (HT-EPA), and hydroxytyrosol extract (Oleacore®) with EPA. One week prior to the intervention, participants will be instructed to refrain from consuming extra virgin olive oil or olives as the primary dietary sources of hydroxytyrosol (wash-out phase). Since three types of nutraceuticals will be evaluated, the study will take place over three separate days, with one week between each intervention.
On each intervention day, following an overnight fast, volunteers will randomly consume one of the nutraceuticals. A polyphenol-free diet will be provided during the 24 hours after the nutraceutical intake.
Blood samples will be collected right before the nutracetical intake at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-consumption. Urine samples will also be collected in 24-hour collection containers containing 0.5 g of ascorbic acid, at the following intervals: -2 to 0 hours (baseline), 0-3 hours, 3-6 hours, 6-10 hours, and 10-24 hours. All of these samples will be stored at -80ºC until analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 to 45 years old
- •Body Mass Index (BMI): 18 to 25 kg/m²
排除标准
- •Presence of chronic illnesses
- •Currently undergoing pharmacological treatment
- •Pregnancy
- •Following a vegetarian or vegan diet
结局指标
主要结局
Targeted and untargeted metabolomics
时间窗: Up to 6 months
The determination of HT metabolites in plasma and urine of the healthy volunteers following the consumption of nutraceuticals will be carried out using both targeted and untargeted metabolomics through high-performance liquid chromatography coupled to an Accurate-Mass Quadrupole Time-of-Flight (QToF) with ESI-Jet Stream Technology (HPLC-ESI-QToF, Agilent Technologies). Additionally, three types of nutraceuticals (EPA-HT, EPA+HT-Ac and EPA-Oleacore®) will be tested in order to evaluate the HT bioavailability comparatively.
次要结局
- ox-LDL as marker of oxidative status(Up to 2 months)
研究者
María Raquel Mateos Briz
Investigator
National Research Council, Spain
