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Bioavailability of Xanthones From Mangosteen

This study has been completed.
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Mark Failla, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01425047
First received: August 26, 2011
Last updated: August 31, 2011
Last verified: August 2011
History of Changes
  Purpose

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
Healthy Volunteers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bioavailability and Anti-inflammatory Activities of Mangostins: a Pilot Study

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Xanthones in urine [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
    Urine was collected prior to ingesting mangosteen juice with breakfast and then from consumpotion of juice until 24h.


Secondary Outcome Measures:
  • Xanthones in sera [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
    Blood was collected prior to breakfast, and 1, 2, 3, 4, 6, 8 and 24 hours


Biospecimen Retention:   Samples Without DNA

Sera and urine
Enrollment: 10
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Females ingesting mangosteen juice
Males ingesting mangosteen juice

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
Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425047

Locations
United States, Ohio
The Ohio State University, Clinical Research Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Mark Failla
Ohio State University
Investigators
Principal Investigator: Mark Failla, PhD Ohio State University
  More Information

No publications provided by Ohio State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mark Failla, Professor, Human Nutrition, Associate Dean for Research, The Ohio State University
ClinicalTrials.gov Identifier: NCT01425047     History of Changes
Other Study ID Numbers: 2010H0219
Study First Received: August 26, 2011
Last Updated: August 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
mangosteen
xanthones
dietary supplement
 botanical supplement
bioavailability
Determine bioavailability of mangosteen xanthones in adults

ClinicalTrials.gov processed this record on February 27, 2015