- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01425047
Bioavailability of Xanthones From Mangosteen
Bioavailability and Anti-inflammatory Activities of Mangostins: a Pilot Study
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Ohio
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Columbus, Ohio, Forenede Stater, 43210
- The Ohio State University, Clinical Research Center
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Females ingesting mangosteen juice
|
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Males ingesting mangosteen juice
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Xanthones in urine
Tidsramme: 0-24 hours
|
Urine was collected prior to ingesting mangosteen juice with breakfast and then from consumpotion of juice until 24h.
|
0-24 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Xanthones in sera
Tidsramme: 0-24 hours
|
Blood was collected prior to breakfast, and 1, 2, 3, 4, 6, 8 and 24 hours
|
0-24 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mark Failla, PhD, Ohio State University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2010H0219
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