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Completed

NCT Number: NCT01425047

Bioavailability of Xanthones From Mangosteen

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University, Clinical Research Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mark Failla

Other

Collaborators

  • Ohio State University

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Aug 29, 2011
Registry last updated
Sep 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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