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HealthyNCT06285682

Bioavailability of Hydroxytyrosol in Healthy Adult Humans

A study testing OliPhenolia®) in people with Healthy, run by Anglia Ruskin University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Brief summary: There is current scientific interest in hydroxytyrosol due to its anti-inflammatory and antioxidant properties, efficient protection of vascular tissue and ability to neutralise free radicals via hydrogen donation. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
OliPhenolia®)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited Kingdom
Study dates
3 Feb 2024to 30 Jul 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 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • UK based men and women aged ≥ 21 - 65
  • Written, witnessed and cosigned informed consent
  • Willingness and ability to conform to the full protocol

Who cannot join

  • Current or recent (within the last 4 weeks) engagement with a strict dietary regime i.e., vegetarian / vegan / ketogenic / paleolithic / high protein / weight loss.
  • Any known issues with blood taking.
  • Any known bleeding disorders.
  • Any known allergy to olives, grapes or prunes.
  • Average alcohol use of >21 glasses per week for men and >14 glasses per week for women (on average for the last six months).
  • Any drug or medicine abuse in the last six months
Show all 14Show fewer
  • Known cardiovascular disease, disease related to the immune system (including HIVand hepatitis) and / or the respiratory system.
  • Known Diabetes Mellitus type I or type II.
  • Known renal or liver issues or known thyroid dysfunction.
  • Currently undertaking regular heavy and / or extreme exercise (please discuss with the lead researcher if you are unsure).
  • Current smoker or stopped smoking for <one month prior to the first visit.
  • Major medical or surgical event requiring hospitalisation in the previous three months and / or any scheduled during the scheduled study period.
  • Current participation in any other clinical study within the month previous to the study start date (discuss with the lead researcher if unsure).
  • Known pregnancy and / or lactation (women only)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University

    Cambridge, CB5 8DZ

Other trials in United Kingdom

About this study

Official title: The Dose Response of a Commercially Available Olive Fruit Water (OliPhenolia®) on the Bioavailability of Hydroxytyrosol, and Its Metabolites, Over a Four-hour Time Period in Healthy Adult Humans.

Brief summary: There is current scientific interest in hydroxytyrosol due to its anti-inflammatory and antioxidant properties, efficient protection of vascular tissue and ability to neutralise free radicals via hydrogen donation. Recognised as the potent polyphenol within a commercially available olive-fruit water (OliPhenolia®), data from this research will determine the dose of OliPhenolia® required for the optimum absorption and metabolism of hydroxytyrosol. The primary aim of this research is to identify the dose of hydroxytyrosol (0.5, 1.0 or 1.5 mg∙kg-1) within OliPhenolia® that demonstrates the greatest area under the plasma concentration curve for hydroxytyrosol over a four-hour period. A secondary aim is to assess maximum concentration (CMAX) and time to maximum concentration (TMAX) of total hydroxytyrosol and secondary metabolites (Tyrosol, HT-3-glucoronide, HT-3-sulphate, 3,4-Dihydroxyphenylacetic Acid, Homovanillic Acid and Oleuropein) following consumption of 3 randomised doses of OliPhenolia® on separate occasions with healthy adult volunteers.

Read the detailed description

There is current and significant scientific interest in the use of plant-based polyphenol supplementation to support health, protection against disease and recovery from exercise. Recent literature dictates that daily supplementation (~3d of >1,000mg of polyphenols) may enhance recovery from exercise and can therefore be associated with both an increased frequency of exercise and quality of movement. The large proportion of research to date has focussed on certain fruit extracts (blackcurrant, tart Montmorency cherry or pomegranate juice), however a recent study from our group utilising milled waste olive-water demonstrated that 16 days of supplementation may support recovery from exercise via the blunting of certain oxidative stress markers and enhance low-intensity exercise performance through a reduction in oxygen economy.

To date there has been significant clinical research interest in the properties of waste-water produced when cold pressing olives, which has been shown to contain high concentrations of natural polyphenols, particularly hydroxytyrosol, a potent scavenger of free radicals. Fattoria La Vialla is an Italian-based organic farm producing various products including cold-pressed olive oil. In doing so, they also produce an olive waste-water extract which is commercially available as 'OliPhenolia®' and currently advertised as a 'health promoting supplement'. Whilst several clinical studies have been undertaken using this product, to date there have been no studies investigating the dose response of OliPhenolia® on the bioavailability of hydroxytyrosol, and the secondary metabolites. As such this study proposes to investigate the bioavailability of hydroxytyrosol across three doses of OliPhenolia® (0.5, 1.0 or 1.5mg∙kg-1) in a randomised manner to understand and therefore inform pertinent supplementation strategies to support health and components of exercise.

Following a study briefing and provision of written informed consent, participants will be required to attend the Human Physiology Laboratory at Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University on three occasions. Each visit will follow an identical protocol, providing an randomly assigned dose (0.5, 1.0 or 1.5mg∙kg-1) of olive derived hydroxytyrosol from OliPhenolia® (based on body weight). Participants will be required to complete a weighed food diary and follow to a 'low-polyphenol' diet (pertinent to hydroxytyrosol rich foods) for the three days prior to each visit, as well as consume a standardised pre-visit evening meal the night before each visit. Participants will arrive at each visit in a fasted (~10h) and hydrated state (500mL 1h prior to arrival). Following a resting blood sample, participants will consume one of the three doses of OliPhenolia® and then remain in a comfortable supine position for the remainder of the visit. Water will be provided at 90 and 180 minutes post OliPhenolia® consumption.

Blood samples - two 4mL wholeblood samples will be collected via cannulation at rest and then 20,40, 60, 120 and 240 minutes following each dose. Following collection, blood samples will be immediately centrifuged with plasma allocated into separate cryovials pre treated with 150µL citric acid for the analysis of: i) the main polyphenol compound- hydroxytyrosol; ii) the secondary metabolites of hydroxytyrosol (Tyrosol, HT-3-glucoronide, HT-3-sulphate, 3,4-Dihydroxyphenylacetic Acid, Homovanillic Acid and Oleuropein).

Nutritional supplementation - all products will be supplied/certified independently via Fattoria La Vialla, Italy (https://www.oliphenolia.it/uk/).

Conditions
Healthy
Being tested
OliPhenolia®)
Keywords
Hydroxytyrosol, Bioavailability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OliPhenolia®)Dietary supplement

    Olive derived hydroxytyrosol will be ingested via a commercially available olive fruit wastewater (OliPhenolia®) in a dose relative to participant body mass. Participants will consume three doses within the entire study, one dose per visit, separated by a ≥3 day wash out period.

Study groups in NCT06285682
Study groupRoleWhat they receive
0.5mg∙kg-1 olive derived hydroxytyrosol from OliPhenolia®.ExperimentalOlive derived hydroxytyrosol will be ingested via a commercially available olive fruit wastewater (OliPhenolia®) in a dose relative to participant body mass. In this arm participants will consume and oral bolus of 0.5mg∙kg-1 olive derived hydroxytyrosol.
Receives: Dietary Supplement: OliPhenolia®)
1.0mg∙kg-1 olive derived hydroxytyrosol from OliPhenolia®.ExperimentalOlive derived hydroxytyrosol will be ingested via a commercially available olive fruit wastewater (OliPhenolia®) in a dose relative to participant body mass. In this arm participants will consume and oral bolus of 1.0mg∙kg-1 olive derived hydroxytyrosol.
Receives: Dietary Supplement: OliPhenolia®)
1.5mg∙kg-1 olive derived hydroxytyrosol from OliPhenolia®.ExperimentalOlive derived hydroxytyrosol will be ingested via a commercially available olive fruit wastewater (OliPhenolia®) in a dose relative to participant body mass. In this arm participants will consume and oral bolus of 1.5mg∙kg-1 olive derived hydroxytyrosol.
Receives: Dietary Supplement: OliPhenolia®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hydroxytyrosol bioavailability

    Area under the plasma concentration curve of hydroxytyrosol (mg/L)

    Measured: Four hours

  2. Bioavailability of hydroxytyrosol metabolites.

    Area under the plasma concentration curve of Tyrosol, HT-3-glucoronide, HT-3-sulphate, 3,4-Dihydroxyphenylacetic Acid, Homovanillic Acid and Oleuropein (mg/L)

    Measured: Four hours

Secondary outcomes (4)
  1. Hydroxytyrosol CMax

    Hydroxytyrosol peak plasma concentration (CMAX) in mg/L

    Measured: Four hours

  2. Hydroxytyrosol TMAX

    Time to peak hydroxytyrosol (TMAX in minutes) - hydroxytyrosol measured in mg/L

    Measured: Four hours

  3. CMAX of hydroxytyrosol secondary metabolites

    Peak plasma concentration (CMAX) of Tyrosol, HT-3-glucoronide, HT-3-sulphate, 3,4-Dihydroxyphenylacetic Acid, Homovanillic Acid and Oleuropein - all measured in mg/L

    Measured: Four hours

  4. TMAX of hydroxytyrosol secondary metabolites

    Time to peak concentration (TMAX in minutes) of Tyrosol, HT-3-glucoronide, HT-3-sulphate, 3,4-Dihydroxyphenylacetic Acid, Homovanillic Acid and Oleuropein - all metabolites measured in mg/L

    Measured: Four hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start3 Feb 2024
  3. Primary completion30 Mar 2024
  4. Study completion30 Jul 2024

Resources

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
Participants are randomly assigned a dose of olive-derived hydroxytyrosol in a double-blind manner. Following a ≥3 day wash out participants then cross-over to an alternate dose. This process is then repeated for the third and final dose.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06285682
Sponsor's protocol ID
ETH2324-2826
Status last verified
Oct 2026
First submitted
23 Feb 2024
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing OliPhenolia®) in people with Healthy, run by Anglia Ruskin University at 1 site in United Kingdom.

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 3 inclusion and 14 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 20 Oct 2026. 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 United Kingdom. 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?

Hydroxytyrosol bioavailability (time frame: Four hours). The study lists 2 primary outcomes in all. 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 20 Oct 2026.

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