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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedStudy Start
First participant enrolled
November 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2019
CompletedFebruary 7, 2020
February 1, 2020
1 month
October 31, 2019
February 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
Sequence 1
EXPERIMENTALSequence 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fytexialead
Study Sites (1)
UCAM
Murcia, Spain
Study Officials
- PRINCIPAL INVESTIGATOR
Pedro Alcaraz
UCAM
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2019
First Posted
November 5, 2019
Study Start
November 11, 2019
Primary Completion
December 17, 2019
Study Completion
December 17, 2019
Last Updated
February 7, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share