Evaluation of Bioavailability of Phenolic Compounds From Oxxynea®

NCT ID: NCT03432104

Last Updated: 2018-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-23

Study Completion Date

2018-03-07

Brief Summary

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The aim of this study is to evaluate bioavailability and pharmacokinetics of phenolic compounds from Oxxynea®, a blend of fruit and vegetable extracts, in healthy volunteers, during a randomized, double-blind and cross-over trial. After a single dose supplementation, both metabolic profile and urinary excretion will be determined over a 48h-period by means of High-Performance Liquid Chromatography coupled with a tandem mass spectrometry (HPLC-MS) to identify and quantify phenolic metabolites. In parallel, post-prandial potential anti-oxidative and anti-glycemic properties of Oxxynea® will be determined in blood, following consumption of a cafeteria-type breakfast.

Detailed Description

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Conditions

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Dietary Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Verum

This arm receives 1 x 450 mg-capsule of Oxxynea®, a blend of polyphenol-rich fruit and vegetable extracts

Group Type EXPERIMENTAL

Oxxynea®

Intervention Type DIETARY_SUPPLEMENT

Oxxynea® is a blend of polyphenol-rich extracts from olive, grape, pomegranate, green tea, grapefruit, orange and blueberry. Dosage is 1 x 450 mg-capsule.

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo product is 100% maltodextrin. Dosage is 1 x 450 mg-capsule of identical appearance than the verum capsule.

Placebo

This arms receives 1 x 450 mg-capsule of Placebo, containing maltodextrin only

Group Type PLACEBO_COMPARATOR

Oxxynea®

Intervention Type DIETARY_SUPPLEMENT

Oxxynea® is a blend of polyphenol-rich extracts from olive, grape, pomegranate, green tea, grapefruit, orange and blueberry. Dosage is 1 x 450 mg-capsule.

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo product is 100% maltodextrin. Dosage is 1 x 450 mg-capsule of identical appearance than the verum capsule.

Interventions

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Oxxynea®

Oxxynea® is a blend of polyphenol-rich extracts from olive, grape, pomegranate, green tea, grapefruit, orange and blueberry. Dosage is 1 x 450 mg-capsule.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo product is 100% maltodextrin. Dosage is 1 x 450 mg-capsule of identical appearance than the verum capsule.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* In good general health
* Agreement to adhere to diet considerations

Exclusion Criteria

* Smoking
* Pregnancy / Lactation
* Current use of any medication or food supplement
* Known allergic reaction to components of the supplement/placebo
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fytexia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pedro E Alcaraz Ramon

Role: PRINCIPAL_INVESTIGATOR

UCAM (Universidad Catolica San Antonio de Murcia)

Locations

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UCAM (Universidad Catolica San Antonio de Murcia)

Murcia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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OXCT2018

Identifier Type: -

Identifier Source: org_study_id

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