Mangoselect®: Characterization, Pharmacokinetics and Bioavailability of Xanthone Metabolites

Fytexia

Status: Completed

Conditions: Dietary Modification

Treatments: Dietary Supplement: MNGDPF; Dietary Supplement: MNGEF

Study type: Interventional

Funder types: Industry

Identifiers

NCT04151641

MNGBDP

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups

Sequence 1

Experimental group

Treatment:

Dietary Supplement: MNGDPF

Dietary Supplement: MNGEF

Sequence 2

Experimental group

Treatment:

Dietary Supplement: MNGDPF

Dietary Supplement: MNGEF