Bioavailability of Hydroxytyrosol in Humans Co-administered With EPA (HydroxyOmegaBd)

Higher Council for Scientific Research (CSIC)

Status: Completed

Conditions: Healthy; Young

Treatments: Dietary Supplement: Oleacore®; Dietary Supplement: Hydroxytyrosol eicosapentanoate (HT-EPA); Dietary Supplement: Hydroxytyrosol acetate (HT-Ac)

Study type: Interventional

Funder types: Other

Identifiers

NCT06735222

HYDROXYOMEGA-BIOAVAILABILITY

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 3 patient groups

HT-Ac → HT-EPA → Oleacore®

Experimental group

Description:

Group 1 will consume HT-Ac in the first week, HT-EPA in the second week and Oleacore® in the third week.

Treatment:

Dietary Supplement: Hydroxytyrosol acetate (HT-Ac)

Dietary Supplement: Hydroxytyrosol eicosapentanoate (HT-EPA)

Dietary Supplement: Oleacore®

HT-EPA → Oleacore® → HT-Ac

Experimental group

Description:

Group 2 will consume HT-EPA in the first week, Oleacore® in the second week and HT-Ac in the third week.

Treatment:

Dietary Supplement: Hydroxytyrosol acetate (HT-Ac)

Dietary Supplement: Hydroxytyrosol eicosapentanoate (HT-EPA)

Dietary Supplement: Oleacore®

Oleacore® → HT-Ac → HT-EPA

Experimental group

Description:

Group 3 will consume Oleacore® in the first week, HT-Ac in the second week and HT-EPA in the third week.

Treatment:

Dietary Supplement: Hydroxytyrosol acetate (HT-Ac)

Dietary Supplement: Hydroxytyrosol eicosapentanoate (HT-EPA)

Dietary Supplement: Oleacore®