Mangoselect®: Characterization, Pharmacokinetics and Bioavailability of Xanthone Metabolites

Dietary Modification Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151641
• Other study ID #: MNGBDP
• Status: Completed
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: December 17, 2019

Study information

• Verified date: February 2020
• Source: Fytexia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Modification

Intervention

Dietary Supplement:
• MNGDPF
Standardized mangosteen extract in dry powder form
• MNGEF
Standardized mangosteen extract in encapsulated form

Locations

Country	Name	City	State
Spain	UCAM	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fytexia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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