Bioavailability of Hydroxytyrosol in Humans Co-administered With EPA

NCT06735222 | Completed

• 1 other identifier: HYDROXYOMEGA-BIOAVAILABILITY
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Young

Keywords

Bioavailability; hydroxytyrosol; nutraceutical; omega-3; nutrikinetics

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 months

Secondary Outcomes (1)

• ox-LDL as marker of oxidative status

  Up to 2 months

Study Arms (3)

HT-Ac → HT-EPA → Oleacore®

EXPERIMENTAL

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®

HT-EPA → Oleacore® → HT-Ac

EXPERIMENTAL

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®

Oleacore® → HT-Ac → HT-EPA

EXPERIMENTAL

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®

Interventions

Hydroxytyrosol acetate (HT-Ac) DIETARY_SUPPLEMENT

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

HT-Ac → HT-EPA → Oleacore®; HT-EPA → Oleacore® → HT-Ac; Oleacore® → HT-Ac → HT-EPA

Hydroxytyrosol eicosapentanoate (HT-EPA) DIETARY_SUPPLEMENT

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

HT-Ac → HT-EPA → Oleacore®; HT-EPA → Oleacore® → HT-Ac; Oleacore® → HT-Ac → HT-EPA

Oleacore® DIETARY_SUPPLEMENT

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

HT-Ac → HT-EPA → Oleacore®; HT-EPA → Oleacore® → HT-Ac; Oleacore® → HT-Ac → HT-EPA

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Research Council, Spain: lead
• Olivenova Health Sl: collaborator

Study Sites (1)

Ictan-Csic

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Interventions

3,4-dihydroxyphenylethanol

Study Officials

• Raquel Mateos Briz Tenured Scientist

  1

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Acute, randomized, cross-over, controlled study.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 16, 2024
• Study Start: November 18, 2024
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: April 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)