Bioavailability of Xanthones From Mangosteen

August 31, 2011 updated by: Mark Failla

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University, Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Females ingesting mangosteen juice
Males ingesting mangosteen juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Xanthones in sera
Time Frame: 0-24 hours
Blood was collected prior to breakfast, and 1, 2, 3, 4, 6, 8 and 24 hours
0-24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mark Failla

Collaborators

Ohio State University

Investigators

  • Principal Investigator: Mark Failla, PhD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

August 26, 2011

First Submitted That Met QC Criteria

August 26, 2011

First Posted (Estimate)

August 29, 2011

Study Record Updates

Last Update Posted (Estimate)

September 2, 2011

Last Update Submitted That Met QC Criteria

August 31, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010H0219

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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