Clinical trial NCT01425047: Bioavailability of Xanthones From Mangosteen
Official title: Bioavailability and Anti-inflammatory Activities of Mangostins: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: mangosteen
xanthones
dietary supplement
botanical supplement
bioavailability
Determine bioavailability of mangosteen xanthones in adults
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2011-08-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 5 female and 5 male healthy, non-smoking subjects admitted to the Clinical Research Center at The Ohio State University.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 5 female
* 5 male
* body mass index \</= 30
* normal renal function
* non-smoking

Exclusion Criteria:

* smokers
* acute or chronic diseases
* history of gastrointestinal diseases
* \>/= 10% weight loss
* dietary or herbal supplement within 6 months of study
* pregnancy

Primary outcomes:
measure: Xanthones in urine
timeFrame: 0-24 hours
Secondary outcomes:
measure: Xanthones in sera
timeFrame: 0-24 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University, Clinical Research Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Mark Failla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.