Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04151641
Enrollment
10
Registered
2019-11-05
Start date
2019-11-11
Completion date
2019-12-17
Last updated
2020-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Modification

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.

Interventions

DIETARY_SUPPLEMENTMNGDPF

Standardized mangosteen extract in dry powder form

DIETARY_SUPPLEMENTMNGEF

Standardized mangosteen extract in encapsulated form

Sponsors

Fytexia
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 hoursUrine 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

MeasureTime frameDescription
Difference in plasma concentration of phenolic metabolites between MNGDPF and MNGEFBaseline (post-ingestion), 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 19 hours, 24 hours, 48 hoursPlasma 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026