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Bioavailability of Hydroxytyrosol in Healthy Adult Humans

NCT06285682 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-02-05

No results posted yet for this study

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. 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.

Conditions

  • Healthy

Interventions

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. Participants will consume three doses within the entire study, one dose per visit, separated by a ≥3 day wash out period.

Sponsors & Collaborators

  • Fattoria La Vialla

    collaborator UNKNOWN

  • Instituto Kurz

    collaborator UNKNOWN

  • Anglia Ruskin University

    lead OTHER

Principal Investigators

  • Justin D Roberts, PhD · Anglia Ruskin University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-03
Primary Completion
2024-03-30
Completion
2024-07-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06285682 on ClinicalTrials.gov