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Completed

NCT Number: NCT04151641

Mangoselect®: Characterization, Pharmacokinetics and Bioavailability of Xanthone Metabolites

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.

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Key information

Conditions

Dietary Modification

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCAM

Murcia, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MNGDPF

Dietary Supplement

Standardized mangosteen extract in dry powder form

MNGEF

Dietary Supplement

Standardized mangosteen extract in encapsulated form

Primary outcomes

  1. Difference in urinary metabolites excretion between MNGDPF (Mangoselect dry powder form) and MNGEF (Mangoselect encapsulated form)

    Time frame: Baseline (post-ingestion), 0-3 hours, 3-6 hours, 6-10 hours, 10-14 hours, 14-24 hours, 24-48 hours, 48-72 hours

    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).

Secondary outcomes

  1. Difference in plasma concentration of phenolic metabolites between MNGDPF and MNGEF

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

Fytexia

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 5, 2019
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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