protocolSection identificationModule nctId: NCT06285682, orgStudyIdInfo id: ETH2324-2826, briefTitle: Bioavailability of Hydroxytyrosol in Healthy Adult Humans, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-03, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Anglia Ruskin University, class: OTHER, collaborators name: Fattoria La Vialla, collaborators name: Instituto Kurz, descriptionModule briefSummary: 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., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: 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., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: Volume of nutritional supplement is provided in a double-blinded manner. Both participants and research testers will be masked from knowing the specifics of the volume allocation., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 8, type: ACTUAL, armsInterventionsModule interventions name: OliPhenolia®), outcomesModule primaryOutcomes measure: Hydroxytyrosol bioavailability, primaryOutcomes measure: Bioavailability of hydroxytyrosol metabolites., secondaryOutcomes measure: Hydroxytyrosol CMax, secondaryOutcomes measure: Hydroxytyrosol TMAX, secondaryOutcomes measure: CMAX of hydroxytyrosol secondary metabolites, secondaryOutcomes measure: TMAX of hydroxytyrosol secondary metabolites, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University, city: Cambridge, zip: CB5 8DZ, country: United Kingdom, geoPoint lat: 52.2, lon: 0.11667, hasResults: False