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Completed

NCT Number: NCT06735222

Bioavailability of Hydroxytyrosol in Humans Co-administered With EPA

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ictan-Csic

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 to 45 years old
  • Body Mass Index (BMI): 18 to 25 kg/m²

Exclusion criteria

  • Presence of chronic illnesses
  • Currently undergoing pharmacological treatment
  • Smoking
  • Pregnancy
  • Following a vegetarian or vegan diet

Treatment and study plan

Hydroxytyrosol acetate (HT-Ac)

Dietary Supplement

Hydroxytyrosol acetate (15 mg) orally co-administered with 2 g EPA

Hydroxytyrosol eicosapentanoate (HT-EPA)

Dietary Supplement

Oral intake of hydroxytyrosol eicosapentanoate (15 mg) solubilized in an EPA-enriched oil matrix.

Oleacore®

Dietary Supplement

Oleacore® (containing 15 mg of hydroxytyrosol) orally co-administered with 2 g EPA

Primary outcomes

  1. Targeted and untargeted metabolomics

    Time frame: 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.

Secondary outcomes

  1. ox-LDL as marker of oxidative status

    Time frame: Up to 2 months

    Differences between non-supplemented subjects and those supplemented with HT-Ac, HT-EPA, and Oleacore®, analyzed across different blood collection times.

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • Olivenova Health Sl

Registry information

Official study title

Hydroxytyrosol Bioavailability in Humans: A Comparative Study of Three EPA-Enriched Formulations

Acronym: HydroxyOmegaBd

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 16, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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