Mangoselect®: Characterization, Pharmacokinetics and Bioavailability of Xanthone Metabolites

Evaluation of Absorption and Metabolism of Phenolic Compounds From Mangoselect®, an Extract of Mangosteen. Comparison of Two Versions During a Randomized, Double-blinded and Cross-over Trial

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.

Study Overview

• Status: Completed
• Conditions: Dietary Modification
• Intervention / Treatment: Dietary supplement: MNGDPF; Dietary supplement: MNGEF

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain
    • UCAM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1	Dietary supplement: MNGDPF; Standardized mangosteen extract in dry powder form; Dietary supplement: MNGEF; Standardized mangosteen extract in encapsulated form
Experimental: Sequence 2	Dietary supplement: MNGDPF; Standardized mangosteen extract in dry powder form; Dietary supplement: MNGEF; Standardized mangosteen extract in encapsulated form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in urinary metabolites excretion between MNGDPF (Mangoselect dry powder form) and MNGEF (Mangoselect encapsulated form)	Urine samples will be collected in baseline and up to 72h after ingestion of the supplement according to the time frame. Urinary metabolites will be identified and quantified by High Pressure Liquid Chromatography-Mass spectrometry (HPLC-MS).	Baseline (post-ingestion), 0-3 hours, 3-6 hours, 6-10 hours, 10-14 hours, 14-24 hours, 24-48 hours, 48-72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in plasma concentration of phenolic metabolites between MNGDPF and MNGEF	Plasma samples will be collected in baseline and up to 48h after ingestion of the supplement according to the time frame. Plasma metabolites will be identified and quantified by HPLC-MS.	Baseline (post-ingestion), 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 19 hours, 24 hours, 48 hours

Collaborators and Investigators

• Sponsor: Fytexia
• Investigators: Principal Investigator: Pedro Alcaraz, UCAM

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): December 17, 2019
• Study Completion (Actual): December 17, 2019

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 5, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MNGBDP

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