Bioavailability of Xanthones From Mangosteen

Healthy Volunteers Clinical Trial

Official title:

Bioavailability and Anti-inflammatory Activities of Mangostins: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425047
• Other study ID #: 2010H0219
• Status: Completed
• Phase: N/A
• First received: August 26, 2011
• Last updated: August 31, 2011
• Start date: November 2010
• Est. completion date: February 2011

Study information

• Verified date: August 2011
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Volunteers

Locations

Country	Name	City	State
United States	The Ohio State University, Clinical Research Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Mark Failla	Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Xanthones in urine	Urine was collected prior to ingesting mangosteen juice with breakfast and then from consumpotion of juice until 24h.	0-24 hours	No
Secondary	Xanthones in sera	Blood was collected prior to breakfast, and 1, 2, 3, 4, 6, 8 and 24 hours	0-24 hours	No