An interventional study of Hydroxytyrosol acetate (HT-Ac) and Hydroxytyrosol eicosapentanoate (HT-EPA) in Healthy and Young, sponsored by National Research Council, Spain. Completed at 1 site in Spain. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by National Research Council, Spain · Not applicable, Interventional, and Basic science
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.
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.
National Research Council, Spain is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group 1 will consume HT-Ac in the first week, HT-EPA in the second week and Oleacore® in the third week.
Dietary Supplement: Hydroxytyrosol acetate (HT-Ac) · Dietary Supplement: Hydroxytyrosol eicosapentanoate (HT-EPA) · Dietary Supplement: Oleacore®
Group 2 will consume HT-EPA in the first week, Oleacore® in the second week and HT-Ac in the third week.
Dietary Supplement: Hydroxytyrosol acetate (HT-Ac) · Dietary Supplement: Hydroxytyrosol eicosapentanoate (HT-EPA) · Dietary Supplement: Oleacore®
Group 3 will consume Oleacore® in the first week, HT-Ac in the second week and HT-EPA in the third week.
Dietary Supplement: Hydroxytyrosol acetate (HT-Ac) · Dietary Supplement: Hydroxytyrosol eicosapentanoate (HT-EPA) · Dietary Supplement: Oleacore®
Hydroxytyrosol acetate (15 mg) orally co-administered with 2 g EPA
Oral intake of hydroxytyrosol eicosapentanoate (15 mg) solubilized in an EPA-enriched oil matrix.
Oleacore® (containing 15 mg of hydroxytyrosol) orally co-administered with 2 g EPA
Targeted and untargeted metabolomics
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.
Time frame: Up to 6 months
ox-LDL as marker of oxidative status
Differences between non-supplemented subjects and those supplemented with HT-Ac, HT-EPA, and Oleacore®, analyzed across different blood collection times.
Time frame: Up to 2 months
Plan to share: No
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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National Research Council, Spain