Clinical trial NCT06735222: Bioavailability of Hydroxytyrosol in Humans Co-administered With EPA
Official title: Hydroxytyrosol Bioavailability in Humans: A Comparative Study of Three EPA-Enriched Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Young
Keywords: Bioavailability
hydroxytyrosol
nutraceutical
omega-3
nutrikinetics
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Olivenova Health Sl
First posted: 2024-12-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Acute, randomized, cross-over, controlled study.
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Targeted and untargeted metabolomics
timeFrame: Up to 6 months
Secondary outcomes:
measure: ox-LDL as marker of oxidative status
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ictan-Csic
Study officials:
affiliation: 1
name: Raquel Mateos Briz Tenured Scientist
role: PRINCIPAL_INVESTIGATOR
References: