Mangoselect®: Characterization, Pharmacokinetics and Bioavailability of Xanthone Metabolites

Not Applicable

Completed

• Conditions: Dietary Modification
• Interventions: Dietary Supplement: MNGDPF; Dietary Supplement: MNGEF

• Registration Number: NCT04151641
• Lead Sponsor: Fytexia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-05
• Study Start: 2019-11-11
• Primary Completion: 2019-12-17
• Study Completion: 2019-12-17
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	MNGDPF	-
Sequence 1	MNGDPF	-
Sequence 1	MNGEF	-
Sequence 2	MNGEF	-

Primary Outcome Measures

Name	Time	Method
Difference in urinary metabolites excretion between MNGDPF (Mangoselect dry powder form) and MNGEF (Mangoselect encapsulated form)	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 Outcome Measures

Name	Time	Method
Difference in plasma concentration of phenolic metabolites between MNGDPF and MNGEF	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.

Trial Locations

Locations (1)

UCAM; 🇪🇸 Murcia, Spain