Dietary ModificationNCT04151641
Mangoselect®: Characterization, Pharmacokinetics and Bioavailability of Xanthone Metabolites
A study testing MNGDPF and MNGEF in people with Dietary Modification, run by Fytexia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- MNGDPF and MNGEF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 11 Nov 2019to 17 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Dietary Modification
- Being tested
- MNGDPF, MNGEF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNGDPFDietary supplement
Standardized mangosteen extract in dry powder form
MNGEFDietary supplement
Standardized mangosteen extract in encapsulated form
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Not described Receives: Dietary Supplement: MNGDPF; Dietary Supplement: MNGEF |
| Sequence 2 | Experimental | Not described Receives: Dietary Supplement: MNGDPF; Dietary Supplement: MNGEF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start11 Nov 2019
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fytexia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Alcaraz, Principal investigator, UCAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151641
- Sponsor's protocol ID
- MNGBDP
- Status last verified
- Feb 2020
- First submitted
- 31 Oct 2019
- Last updated
- 7 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04151641
- Acronym / sponsor ID
- MNGBDP
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- FytexiaIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Dietary Supplement: MNGDPF, Dietary Supplement: MNGEF |
| Sequence 2 | Experimental | Dietary Supplement: MNGDPF, Dietary Supplement: MNGEF |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MNGDPFStandardized mangosteen extract in dry powder form | Dietary supplement | Sequence 1, Sequence 2 |
| MNGEFStandardized mangosteen extract in encapsulated form | Dietary supplement | Sequence 1, Sequence 2 |
Primary outcome
Difference in urinary metabolites excretion between MNGDPF (Mangoselect dry powder form) and MNGEF (Mangoselect encapsulated form)
Time frame: 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).
1 secondary outcome
Difference in plasma concentration of phenolic metabolites between MNGDPF and MNGEF
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Alcaraz principal investigator
UCAM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MNGDPF and MNGEF in people with Dietary Modification, run by Fytexia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in urinary metabolites excretion between MNGDPF (Mangoselect dry powder form) and MNGEF (Mangoselect encapsulated form) (time frame: Baseline (post-ingestion), 0-3 hours, 3-6 hours, 6-10 hours, 10-14 hours, 14-24 hours, 24-48 hours, 48-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.