Bioavailability of Hydroxytyrosol in Humans Co-administered With EPA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2024-12-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cardiometabolic Properties of Omega-3 Functionalized With Hydroxytyrosol

NCT06992323

Hypertriglyceridemia Normal

ACTIVE_NOT_RECRUITING NA

The Microalga Phaeodactylum Tricornutum a Potential Fish Substitute?- Pharmacokinetic Study

NCT06450808

Pharmacokinetic Parameters

ACTIVE_NOT_RECRUITING NA

Bioavailability of EPA and DHA From Two Dietary Supplements

NCT01908374

Hypertriglyceridemia

UNKNOWN NA

A Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA

NCT06629103

Optimal Absorption of Omega-3 Healthy

ACTIVE_NOT_RECRUITING PHASE4

Cardioprotective Properties of ELAIOTSIPOURA

NCT04440202

Cardiometabolic Health

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Young

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Acute, randomized, cross-over, controlled study.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HT-Ac → HT-EPA → Oleacore®

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

Group Type EXPERIMENTAL