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Bioavailability of Xanthones From Mangosteen

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ClinicalTrials.gov Identifier: NCT01425047
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : September 2, 2011
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Mark Failla, Ohio State University

Study Description
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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.

Condition or disease
Healthy Volunteers

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
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bioavailability and Anti-inflammatory Activities of Mangostins: a Pilot Study
Study Start Date : November 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : February 2011
Groups and Cohorts
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Group/Cohort
Females ingesting mangosteen juice
Males ingesting mangosteen juice


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Xanthones in sera [ Time Frame: 0-24 hours ]
    Blood was collected prior to breakfast, and 1, 2, 3, 4, 6, 8 and 24 hours


Biospecimen Retention:   Samples Without DNA
Sera and urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425047


Locations
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United States, Ohio
The Ohio State University, Clinical Research Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Mark Failla
Ohio State University
Investigators
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Principal Investigator: Mark Failla, PhD Ohio State University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mark Failla, Professor, Human Nutrition, Associate Dean for Research, Ohio State University
ClinicalTrials.gov Identifier: NCT01425047    
Other Study ID Numbers: 2010H0219
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: August 2011
Keywords provided by Mark Failla, Ohio State University:
mangosteen
xanthones
dietary supplement
 botanical supplement
bioavailability
Determine bioavailability of mangosteen xanthones in adults