HealthyHydroxyOmegaBdNCT06735222
Bioavailability of Hydroxytyrosol in Humans Co-administered With EPA
A study testing Hydroxytyrosol acetate (HT-Ac), Hydroxytyrosol eicosapentanoate (HT-EPA) and Oleacore® in people with Healthy and Young, run by National Research Council, Spain at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Hydroxytyrosol acetate (HT-Ac), Hydroxytyrosol eicosapentanoate (HT-EPA) and Oleacore®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 18 Nov 2024to 4 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 45 years old
- Body Mass Index (BMI): 18 to 25 kg/m²
Who cannot join
- Presence of chronic illnesses
- Currently undergoing pharmacological treatment
- Smoking
- Pregnancy
- Following a vegetarian or vegan diet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydroxytyrosol Bioavailability in Humans: A Comparative Study of Three EPA-Enriched Formulations
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.
Read the 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.
- Being tested
- Hydroxytyrosol acetate (HT-Ac), Hydroxytyrosol eicosapentanoate (HT-EPA), Oleacore®
- Keywords
- Bioavailability, hydroxytyrosol, nutraceutical, omega-3, nutrikinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Hydroxytyrosol acetate (HT-Ac); Dietary Supplement: Hydroxytyrosol eicosapentanoate (HT-EPA); Dietary Supplement: Oleacore® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (1)
ox-LDL as marker of oxidative status
Differences between non-supplemented subjects and those supplemented with HT-Ac, HT-EPA, and Oleacore®, analyzed across different blood collection times.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start18 Nov 2024
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Acute, randomized, cross-over, controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Olivenova Health Sl
- Responsible party
- Principal investigator, María Raquel Mateos Briz, National Research Council, Spain
- Investigators
- Raquel Mateos Briz Tenured Scientist, Principal investigator, 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735222
- Sponsor's protocol ID
- HYDROXYOMEGA-BIOAVAILABILITY
- Acronym
- HydroxyOmegaBd
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxytyrosol Bioavailability in Humans: A Comparative Study of Three EPA-Enriched Formulations
- ClinicalTrials.gov ID
- NCT06735222
- Acronym / sponsor ID
- HydroxyOmegaBd / HYDROXYOMEGA-BIOAVAILABILITY
- Keywords
- Bioavailability, hydroxytyrosol, nutraceutical, omega-3, nutrikinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Olivenova Health Sl
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Acute, randomized, cross-over, controlled study.
| Arm | Type | Receives |
|---|---|---|
| HT-Ac → HT-EPA → Oleacore® | Experimental | Dietary Supplement: Hydroxytyrosol acetate (HT-Ac), Dietary Supplement: Hydroxytyrosol eicosapentanoate (HT-EPA), Dietary Supplement: Oleacore®Group 1 will consume HT-Ac in the first week, HT-EPA in the second week and Oleacore® in the third week. |
| HT-EPA → Oleacore® → HT-Ac | Experimental | Dietary Supplement: Hydroxytyrosol acetate (HT-Ac), Dietary Supplement: Hydroxytyrosol eicosapentanoate (HT-EPA), Dietary Supplement: Oleacore®Group 2 will consume HT-EPA in the first week, Oleacore® in the second week and HT-Ac in the third week. |
| Oleacore® → HT-Ac → HT-EPA | Experimental | Dietary Supplement: Hydroxytyrosol acetate (HT-Ac), Dietary Supplement: Hydroxytyrosol eicosapentanoate (HT-EPA), Dietary Supplement: Oleacore®Group 3 will consume Oleacore® in the first week, HT-Ac in the second week and HT-EPA in the third week. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 18 to 45 years old
- Body Mass Index (BMI): 18 to 25 kg/m²
Key exclusion criteria (5 listed)
- Presence of chronic illnesses
- Currently undergoing pharmacological treatment
- Smoking
- Pregnancy
- Following a vegetarian or vegan diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxytyrosol acetate (HT-Ac)Hydroxytyrosol acetate (15 mg) orally co-administered with 2 g EPA | Dietary supplement | HT-Ac → HT-EPA → Oleacore®, HT-EPA → Oleacore® → HT-Ac, Oleacore® → HT-Ac → HT-EPA |
| Hydroxytyrosol eicosapentanoate (HT-EPA)Oral intake of hydroxytyrosol eicosapentanoate (15 mg) solubilized in an EPA-enriched oil matrix. | Dietary supplement | HT-Ac → HT-EPA → Oleacore®, HT-EPA → Oleacore® → HT-Ac, Oleacore® → HT-Ac → HT-EPA |
| Oleacore®Oleacore® (containing 15 mg of hydroxytyrosol) orally co-administered with 2 g EPA | Dietary supplement | HT-Ac → HT-EPA → Oleacore®, HT-EPA → Oleacore® → HT-Ac, Oleacore® → HT-Ac → HT-EPA |
Primary outcome
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.
1 secondary outcome
ox-LDL as marker of oxidative status
Time frame: Up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel Mateos Briz Tenured Scientist principal investigator
1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxytyrosol acetate (HT-Ac), Hydroxytyrosol eicosapentanoate (HT-EPA) and Oleacore® in people with Healthy and Young, run by National Research Council, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Targeted and untargeted metabolomics (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.