Bioavailability of Hydroxytyrosol in Healthy Adult Humans

NCT06285682 | Completed

• 1 other identifier: ETH2324-2826
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hydroxytyrosol; Bioavailability

Outcome Measures

Primary Outcomes (2)

• Hydroxytyrosol bioavailability

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

  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)

  Four hours

Secondary Outcomes (4)

• Hydroxytyrosol CMax

  Four hours

• Hydroxytyrosol TMAX

  Four hours

• CMAX of hydroxytyrosol secondary metabolites

  Four hours

• TMAX of hydroxytyrosol secondary metabolites

  Four hours

Study Arms (3)

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.

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.

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.

Dietary Supplement: OliPhenolia®)

Interventions

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.

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®.

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Anglia Ruskin University: lead
• Fattoria La Vialla: collaborator
• Instituto Kurz: collaborator

Study Sites (1)

Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University

Cambridge, CB5 8DZ, United Kingdom

Location

Study Officials

• Justin D Roberts, PhD

  Anglia Ruskin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: February 29, 2024
• Study Start: February 3, 2024
• Primary Completion: March 30, 2024
• Study Completion: July 30, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)