Mangoselect®: Characterization, Pharmacokinetics and Bioavailability of Xanthone Metabolites

NCT ID: NCT04151641

Last Updated: 2020-02-07

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

2019-11-11

Study Completion Date

2019-12-17

Brief Summary

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The aim of this study is to compare pharmacokinetics and bioavailability of phenolic compounds, mainly xanthones, from a mangosteen extract, either ingested in a dry powder form or in an encapsulated form. Absorption and metabolism will be determined by measuring urinary excretion of phenolic metabolites and blood metabolic profile over 72 hours by means of High Pressure Liquid Chromatography (HPLC) coupled with tandem mass spectroscopy.

The design of this study is a cross-over, double-blind and randomized trial on 10 healthy subjects.

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

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sequence 1

Group Type EXPERIMENTAL

MNGDPF

Intervention Type DIETARY_SUPPLEMENT

Standardized mangosteen extract in dry powder form

MNGEF

Intervention Type DIETARY_SUPPLEMENT

Standardized mangosteen extract in encapsulated form

Sequence 2

Group Type EXPERIMENTAL

MNGDPF

Intervention Type DIETARY_SUPPLEMENT

Standardized mangosteen extract in dry powder form

MNGEF

Intervention Type DIETARY_SUPPLEMENT

Standardized mangosteen extract in encapsulated form

Interventions

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MNGDPF

Standardized mangosteen extract in dry powder form

Intervention Type DIETARY_SUPPLEMENT

MNGEF

Standardized mangosteen extract in encapsulated form

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated informed consent study
* Stated willingness to comply with all the study procedures and availability for the duration of the study
* Male and female
* Normal BMI range (18.50-24.99)
* In good general health as evidenced by medical history
* Ability to take oral medication and be willing to adhere to lifestyle considerations

Exclusion Criteria

* Current use of any medication or food supplement
* Pregnancy or lactation
* Known allergic reaction to mangosteen
* Metabolic disorders or any kind of disease
* Currant smoker
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 Alcaraz

Role: PRINCIPAL_INVESTIGATOR

UCAM

Locations

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UCAM

Murcia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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MNGBDP

Identifier Type: -

Identifier Source: org_study_id

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