Bioavailability of Hydroxytyrosol From Olive Watery Extract Supplements

July 13, 2021 updated by: Daacro

Bioavailability of Hydroxytyrosol From Two Olive Watery Extract Supplements and Their Effects on Lipid Peroxidation

The aim of this cross-over study is to assess the bioavailability of hydroxytyrosol in healthy males after the intake of two olive watery extract supplements and one olive oil. Blood and urine samples will be collected before and after intake of the investigational products. Sample will be analysed regarding the level of hydroxytyrosol and preventing lipid peroxidation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Hydroxytyrosol is a phenolic phytochemical naturally occurring in olives with potential antioxidant, anti-inflammatory, and health benefits mainly related with cardiovascular diseases [for review see Covas et al., 2015]. OliPhenolia® bitter and OliPhenolia® are two food supplements resulting from the liquid by-product generated during olive oil production, that are rich in olive polyphenols, mainly hydroxytyrosol. Hydroxytyrosol and its derivatives (tyrosol and oleuropein) are present in higher levels in the watery extracts from olives when compared with the oil fraction.

Most studies on hydroxytyrosol bioavailability have been performed by consuming it with olive oil or as a highly purified molecule. In a study by D'Angelo and collaborators [D'Angelo et al, 2001] it was shown that hydroxytyrosol can be rapidly absorbed from the blood and distributed in the human body, metabolized and eliminated rapidly in urine mainly as a glucuronide. It has been estimated that the absorption process depends on the composition of the food matrix through which hydroxytyrosol is administered [Visioli et al, 2003], when consumed together with fats (e.g. olive oil) it is absorbed in a greater extent. By being a water-soluble molecule, hydroxytyrosol is only slightly soluble in fats, therefore naturally present in significantly higher concentrations in the olive fruit aqueous fractions than in the olive oil.

Overall, the human studies support the need to evaluate the bioavailability of hydroxytyrosol following its administration as a major component of the two aqueous food supplements, OliPhenolia® and OliPhenolia® bitter.

Study Procedure:

After detailed information and signed informed consent all males meeting the inclusion and exclusion criteria will be included into the study. During their study participation, participants are not allowed to consume any products with or made from olives or olive oil as well as alcohol and supplements with hydroxytyrosol, vitamins, minerals and antioxidants. Products high in polyphenols and antioxidants may only be consumed in moderate amounts. Three days prior to and at each intervention day, volunteers will be requested to avoid moderate or intense physical activity.

After a run-in period, participants will return in a fasted state to the site for the first intervention visit. Volunteers will be asked to empty their bladder at home 2h before IP intake. After arriving at the site, a baseline blood and urine sample (-5 min) will be collected and the participants receive according to the individual allocation determining the sequence of the IP intake either one of the olive watery extract supplements (OliPhenolia® bitter or OliPhenolia®) or the olive oil first. Further blood and urine samples will follow (+30 min, +60 min, +90 min, +120 min, +240 min, +12 h). Vital signs and AEs will be checked throughout the intervention visit. Participants will receive several snacks and water during their visit.

After a one-week washout phase each, participants will return to their second and third intervention visit. The same procedures as on intervention visit 1 will take place except the IP intake will vary according to the individual allocation.

At the end of the third intervention visit, participants will receive a study compensation.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rhineland-Palatinate
      • Trier, Rhineland-Palatinate, Germany, 54296
        • daacro GmbH & Co. KG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Self-reported healthy men aged 21-50,
  • subject has an adequate understanding of the study and signs the informed consent to participate in the study,
  • willingness to follow dietary and physical activity restrictions during study participation,
  • body mass index range: >18.5 and <29.9 kg/m2.

Exclusion Criteria:

  • Any known allergies to IPs (olives and their derivates),
  • any acute and chronic diseases (e.g. diagnosis of diabetes mellitus, hypertension, dyslipidemia or other cardiometabolic disorders, diagnosed hepatic, renal, or cardiovascular disease),
  • any kind of eating disorders,
  • not fluent in German,
  • any previous (last 14 days prior to screening) and any ongoing pharmacological therapy (e.g. any medication, vaccination, infusion),
  • any intake of nutritional supplements,
  • any known addiction to drugs and/or alcohol,
  • smoker,
  • Investigator or physician doubts truthfulness of self-reported health information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Group A will receive Oliphenolia® bitter on intervention visit 1 followed by Oliphenolia® on intervention visit 2 and followed by La Vialla Extra Virgin Olive Oil with 5 mg hydroxytyrosol on the third and final intervention visit
Dietary supplement: Oliphenolia® bitter
  • ingredients: concentrated watery extract of olives 94%, lemon juice 6%
  • 35 mg hydroxytyrosol, 0,24 mg Oleuropein
Dietary supplement: Oliphenolia®
  • ingredients: grape juice concentrate 70%, concentrated watery extract of olives 30%
  • 38 mg hydroxytyrosol, 0,28 mg Oleuropein
Dietary supplement: La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol
  • extra virgin olive oil
  • 5 mg hydroxytyrosol
Active Comparator: Group B
Group B will receive Oliphenolia® on intervention visit 1 followed by La Vialla Extra Virgin Olive Oil with 5 mg hydroxytyrosol on intervention visit 2 and followed by Oliphenolia® bitter on the third and final intervention visit
Dietary supplement: Oliphenolia® bitter
  • ingredients: concentrated watery extract of olives 94%, lemon juice 6%
  • 35 mg hydroxytyrosol, 0,24 mg Oleuropein
Dietary supplement: Oliphenolia®
  • ingredients: grape juice concentrate 70%, concentrated watery extract of olives 30%
  • 38 mg hydroxytyrosol, 0,28 mg Oleuropein
Dietary supplement: La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol
  • extra virgin olive oil
  • 5 mg hydroxytyrosol
Active Comparator: Group C
Group C will receive La Vialla Extra Virgin Olive Oil with 5 mg hydroxytyrosol on intervention visit 1 followed by Oliphenolia® bitter on intervention visit 2 and followed by Oliphenolia® on the third and final intervention visit
Dietary supplement: Oliphenolia® bitter
  • ingredients: concentrated watery extract of olives 94%, lemon juice 6%
  • 35 mg hydroxytyrosol, 0,24 mg Oleuropein
Dietary supplement: Oliphenolia®
  • ingredients: grape juice concentrate 70%, concentrated watery extract of olives 30%
  • 38 mg hydroxytyrosol, 0,28 mg Oleuropein
Dietary supplement: La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol
  • extra virgin olive oil
  • 5 mg hydroxytyrosol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioavailability of hydroxytyrosol in urine
Time Frame: -2 hrs to IP intake, 0 to 30 min, 30 to 60 min, 60 to 90 min, 90 to 120 min, 120 to 240 min and +4h to +12h
The primary objective is the bioavailability of hydroxytyrosol and its derivatives from both food supplements (OliPhenolia® bitter and OliPhenolia®) in urine when compared to extra virgin olive oil.
-2 hrs to IP intake, 0 to 30 min, 30 to 60 min, 60 to 90 min, 90 to 120 min, 120 to 240 min and +4h to +12h
Bioavailability of hydroxytyrosol in blood
Time Frame: 5 min. before IP intake, 30, 60, 90, 120, 240 min and 12 h
The primary objective is the bioavailability of hydroxytyrosol and its derivatives from both food supplements (OliPhenolia® bitter and OliPhenolia®) in urine when compared to extra virgin olive oil.
5 min. before IP intake, 30, 60, 90, 120, 240 min and 12 h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxidative damages to lipids in blood
Time Frame: 5 min. before IP intake, 30, 60, 90, 120, 240 min and 12 h
The secondary outcome is the measurement of the oxidized LDL(low-density lipoprotein) in blood
5 min. before IP intake, 30, 60, 90, 120, 240 min and 12 h
changes in F2alpha-isoprostanes in urine
Time Frame: -2 hrs to IP intake, 0 to 30 min, 30 to 60 min, 60 to 90 min, 90 to 120 min, 120 to 240 min and +4h to +12h
The secondary outcome is the measurement of changes in F2alpha-isoprostanes in urine.
-2 hrs to IP intake, 0 to 30 min, 30 to 60 min, 60 to 90 min, 90 to 120 min, 120 to 240 min and +4h to +12h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daacro

Collaborators

ISTITUTO KURZ ITALIA S.R.L.
Institut Kurz GmbH
Fattoria La Vialla di Gianni, Antonio e Bandino Lo Franco Soc. Agr. Sempl.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Actual)

July 2, 2021

Study Completion (Actual)

July 2, 2021

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IK03-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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