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.
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
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- 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
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 group | Role | What they receive |
|---|---|---|
| 0.5mg∙kg-1 olive derived hydroxytyrosol from OliPhenolia®. | Experimental | Olive 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®. | Experimental | Olive 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®. | Experimental | Olive 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.
Hydroxytyrosol bioavailability
Area under the plasma concentration curve of hydroxytyrosol (mg/L)
Measured: Four hours
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)
Hydroxytyrosol CMax
Hydroxytyrosol peak plasma concentration (CMAX) in mg/L
Measured: Four hours
Hydroxytyrosol TMAX
Time to peak hydroxytyrosol (TMAX in minutes) - hydroxytyrosol measured in mg/L
Measured: Four hours
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
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.
- First posted29 Feb 2024
- Study start3 Feb 2024
- Primary completion30 Mar 2024
- Study completion30 Jul 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
- 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)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Collaborators
- Fattoria La Vialla, Instituto Kurz
- Responsible party
- Principal investigator, Justin Roberts, Anglia Ruskin University
- Investigators
- Justin D Roberts, PhD, Principal investigator, Anglia Ruskin University
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06285682
- Acronym / sponsor ID
- ETH2324-2826
- Conditions
- Healthy
- Keywords
- Hydroxytyrosol, Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Collaborators
- Fattoria La Vialla, Instituto Kurz
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 29 Feb 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.
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.
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/).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 0.5mg∙kg-1 olive derived hydroxytyrosol from OliPhenolia®. | Experimental | Dietary Supplement: OliPhenolia®)Olive 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. |
| 1.0mg∙kg-1 olive derived hydroxytyrosol from OliPhenolia®. | Experimental | Dietary Supplement: OliPhenolia®)Olive 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. |
| 1.5mg∙kg-1 olive derived hydroxytyrosol from OliPhenolia®. | Experimental | Dietary Supplement: OliPhenolia®)Olive 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- UK based men and women aged ≥ 21 - 65
- Written, witnessed and cosigned informed consent
- Willingness and ability to conform to the full protocol
Key exclusion criteria (14 listed)
- 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).
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 |
|---|---|---|
| OliPhenolia®)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. | Dietary supplement | 0.5mg∙kg-1 olive derived hydroxytyrosol from OliPhenolia®., 1.0mg∙kg-1 olive derived hydroxytyrosol from OliPhenolia®., 1.5mg∙kg-1 olive derived hydroxytyrosol from OliPhenolia®. |
Primary outcome
Hydroxytyrosol bioavailability
Time frame: Four hours
Area under the plasma concentration curve of hydroxytyrosol (mg/L)
Bioavailability of hydroxytyrosol metabolites.
Time frame: Four hours
Area under the plasma concentration curve of Tyrosol, HT-3-glucoronide, HT-3-sulphate, 3,4-Dihydroxyphenylacetic Acid, Homovanillic Acid and Oleuropein (mg/L)
4 secondary outcomes
Hydroxytyrosol CMax
Time frame: Four hours
Hydroxytyrosol TMAX
Time frame: Four hours
CMAX of hydroxytyrosol secondary metabolites
Time frame: Four hours
TMAX of hydroxytyrosol secondary metabolites
Time frame: Four hours
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 20 Oct 2026.
- 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.
Justin D Roberts, PhD principal investigator
Anglia Ruskin University
1 site in 1 country: see every site and its status.
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.