Healthy VolunteersNCT01425047
Bioavailability of Xanthones From Mangosteen
An observational study of Healthy Volunteers, run by Mark Failla at 1 site in United States.
Trial summary
Mangosteen is a tropical tree. The peel of mangosteen fruit is used in traditional medicine. The purpose of this study was to determine the bioavailability of the xanthones from mangosteen juice in adult human subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Feb 2011
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 5 female and 5 male healthy, non-smoking subjects admitted to the Clinical Research Center at The Ohio State University.
Who may be able to join
- 5 female
- 5 male
- body mass index </= 30
- normal renal function
- non-smoking
Who cannot join
- smokers
- acute or chronic diseases
- history of gastrointestinal diseases
- >/= 10% weight loss
- dietary or herbal supplement within 6 months of study
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University, Clinical Research Center
Columbus, Ohio, 43210
About this study
Official title: Bioavailability and Anti-inflammatory Activities of Mangostins: a Pilot Study
Mangosteen is a tropical tree. The peel of mangosteen fruit is used in traditional medicine. The purpose of this study was to determine the bioavailability of the xanthones from mangosteen juice in adult human subjects.
Read the detailed description
Garcinia mangostana L. (mangosteen) is a tropical tree native to Southeast Asia. The pericarp of mangosteen fruit is used in traditional medicine to treat inflammation, infections, wounds, and diarrhea. The proposed health-promoting effects have been attributed to a family of polyphenols referred to as xanthones. Since its introduction into the United States, juices and products containing mangosteen fruit have become a top-selling botanical dietary supplement. This commercial success largely has been the result of aggressive marketing of health claims based on in vitro observations and anecdotal reports.
The purpose of this study was to determine the bioavailability of xanthones from mangosteen juice in adult human subjects. After an overnight fast of at least 10h, male and female subjects were admitted to the Ohio State University Clinical Research Center. Volunteers ingested 2 ounces of 100% mangosteen juice as part of a western-style breakfast. Pericarp particles accounted for 1% of the mass and 99% of total xanthone content in the juice. This dose provided 130 ± 2 mg total xanthones. Blood was collected prior to breakfast and 1,2,3,4,6,8 and 24h. Subjects were fed a mangosteen-free lunch and released from the unit after the 8h collection, refraining from mangosteen containing products until final collection of blood at 24h. Urine was collected for the 24 test period.
- Conditions
- Healthy Volunteers
- Keywords
- mangosteen, xanthones, dietary supplement, botanical supplement, bioavailability, Determine bioavailability of mangosteen xanthones in adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Females ingesting mangosteen juice | Not described | |
| Males ingesting mangosteen juice | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xanthones in urine
Urine was collected prior to ingesting mangosteen juice with breakfast and then from consumpotion of juice until 24h.
Measured: 0-24 hours
Secondary outcomes (1)
Xanthones in sera
Blood was collected prior to breakfast, and 1, 2, 3, 4, 6, 8 and 24 hours
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Failla
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Sponsor-investigator, Mark Failla, Ohio State University
- Investigators
- Mark Failla, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425047
- Sponsor's protocol ID
- 2010H0219
- Status last verified
- Aug 2011
- First submitted
- 26 Aug 2011
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chitchumroonchokchai C, Riedl KM, Suksumrarn S, Clinton SK, Kinghorn AD, Failla ML. Xanthones in mangosteen juice are absorbed and partially conjugated by healthy adults. J Nutr. 2012 Apr;142(4):675-80. doi: 10.3945/jn.111.156992. Epub 2012 Mar 7.
PubMed 22399525
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Anti-inflammatory Activities of Mangostins: a Pilot Study
- ClinicalTrials.gov ID
- NCT01425047
- Acronym / sponsor ID
- 2010H0219
- Conditions
- Healthy Volunteers
- Keywords
- mangosteen, xanthones, dietary supplement, botanical supplement, bioavailability, Determine bioavailability of mangosteen xanthones in adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mark FaillaUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- Nov 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 29 Aug 2011 (estimated)
- 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.
Mangosteen is a tropical tree. The peel of mangosteen fruit is used in traditional medicine. The purpose of this study was to determine the bioavailability of the xanthones from mangosteen juice in adult human subjects.
Detailed description
Garcinia mangostana L. (mangosteen) is a tropical tree native to Southeast Asia. The pericarp of mangosteen fruit is used in traditional medicine to treat inflammation, infections, wounds, and diarrhea. The proposed health-promoting effects have been attributed to a family of polyphenols referred to as xanthones. Since its introduction into the United States, juices and products containing mangosteen fruit have become a top-selling botanical dietary supplement. This commercial success largely has been the result of aggressive marketing of health claims based on in vitro observations and anecdotal reports.
The purpose of this study was to determine the bioavailability of xanthones from mangosteen juice in adult human subjects. After an overnight fast of at least 10h, male and female subjects were admitted to the Ohio State University Clinical Research Center. Volunteers ingested 2 ounces of 100% mangosteen juice as part of a western-style breakfast. Pericarp particles accounted for 1% of the mass and 99% of total xanthone content in the juice. This dose provided 130 ± 2 mg total xanthones. Blood was collected prior to breakfast and 1,2,3,4,6,8 and 24h. Subjects were fed a mangosteen-free lunch and released from the unit after the 8h collection, refraining from mangosteen containing products until final collection of blood at 24h. Urine was collected for the 24 test period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Females ingesting mangosteen juice | – | – |
| Males ingesting mangosteen juice | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 5 female and 5 male healthy, non-smoking subjects admitted to the Clinical Research Center at The Ohio State University.
Key inclusion criteria (5 listed)
- 5 female
- 5 male
- body mass index </= 30
- normal renal function
- non-smoking
Key exclusion criteria (6 listed)
- smokers
- acute or chronic diseases
- history of gastrointestinal diseases
- >/= 10% weight loss
- dietary or herbal supplement within 6 months of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Xanthones in urine
Time frame: 0-24 hours
Urine was collected prior to ingesting mangosteen juice with breakfast and then from consumpotion of juice until 24h.
1 secondary outcome
Xanthones in sera
Time frame: 0-24 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 2 Sep 2011.
- Derived from this study: PubMed 22399525Chitchumroonchokchai C, Riedl KM, Suksumrarn S, Clinton SK, Kinghorn AD, Failla ML. Xanthones in mangosteen juice are absorbed and partially conjugated by healthy adults. J Nutr. 2012 Apr;142(4):675-80. doi: 10.3945/jn.111.156992. Epub 2012 Mar 7.
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Screening Protocol
Pain
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.
Mark Failla, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Mark Failla at 1 site in United States.
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 5 inclusion and 6 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 2 Sep 2011. 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 United States. 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?
Xanthones in urine (time frame: 0-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01425047, which also lists 1 linked publication.
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 2 Sep 2011.