Mangoselect®: Characterization, Pharmacokinetics and Bioavailability of Xanthone Metabolites

Study Overview
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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.

Official Title
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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

Conditions
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Dietary Modification

Intervention / Treatment
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* Dietary Supplement: MNGDPF
* Dietary Supplement: MNGEF


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br> | Dietary Supplement: MNGDPF<br>* Standardized mangosteen extract in dry powder form<br>Dietary Supplement: MNGEF<br>* Standardized mangosteen extract in encapsulated form<br>|
| Experimental: Sequence 2<br> | Dietary Supplement: MNGDPF<br>* Standardized mangosteen extract in dry powder form<br>Dietary Supplement: MNGEF<br>* Standardized mangosteen extract in encapsulated form<br>|

What is the study measuring?
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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 |