Bioavailability of Golden Rice Carotenoids in Humans - Tabular View

Tracking Information
First Received Date ^ICMJE	May 16, 2008
Last Updated Date	May 16, 2008
Start Date ^ICMJE	August 2004
Estimated Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 16, 2008)	The enrichment of labeled golden rice β-carotene and its conversion to labeled retinol in serum samples after the golden rice meal as compared to the reference dose of vitamin A that is labeled differently. [ Time Frame: 33 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Bioavailability of Golden Rice Carotenoids in Humans
Official Title ^ICMJE	Bioavailability of Golden Rice Carotenoids in Humans
Brief Summary	This investigation protocol uses an isotope reference method to evaluate bioavailability of ß-C in rice and its bioconversion to vitamin A. A well-nourished population will be fed hydroponically grown Golden Rice containing ~ 1 mg of β-carotene at day 8 after a reference dose of vitamin A at day 1. The blood samples will be collected up to 33 days after the doses. The absorption kinetics will be determined by tracking both vitamin A and β-carotene in human serum. Blood responses to Golden Rice β-carotene will be determined and evaluated. The vitamin A value of Golden Rice can thus be quantitatively determined.
Detailed Description	Recently, scientists have genetically engineered "golden rice" that contains 1.6 ug ß-carotene in a gram of dry rice (12). Since the vitamin A equivalency varies from 2 ug (oil dose) to 27 ug (vegetable) carotene to 1 retinol equivalent and the equivalency is matrix dependent, it is necessary to know what the vitamin A equivalency of golden rice beta-carotene is. The determination of the absorption and conversion of golden rice beta-carotene is of importance for designing food programs in many rice-eating regions of the world, where vitamin A deficiency is common. To evaluate the absorption and intestinal conversion of rice beta-carotene after an acute dose of golden rice, an intrinsically labeled Golden Rice with a labeled reference dose of vitamin A are used. We propose to conduct a pilot study on the US adults with normal vitamin A status (n = 6). The specific aims of this pilot study are: To determine ß-carotene response kinetics following a meal of golden rice; To determine retinol kinetics from the golden rice and from the labeled vitamin A dose; To determine vitamin A value of golden rice ß-carotene in adults with normal vitamin A status. The determination of the absorption and conversion of golden rice ß-carotene is of importance for designing food programs in many rice-eating regions of the world, where vitamin A deficiency is common.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Bio-equivalence Study
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Dietary Supplement: golden rice An acute dose of cooked golden rice containing ~ 1 mg of ß-carotene Other Name: golden rice carotenoids
Study Arms / Comparison Groups	1: Experimental Intervention: Dietary Supplement: golden rice
Publications *	Tang G, Qin J, Dolnikowski GG, Russell RM, Grusak MA. Golden Rice is an effective source of vitamin A. Am J Clin Nutr. 2009 Jun;89(6):1776-83. Epub 2009 Apr 15.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	6
Estimated Completion Date	August 2008
Estimated Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: heathy health Exclusion Criteria: GI track problems
Gender	Both
Ages	40 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00680355
Responsible Party	Guangwen Tang, Tufts University
Study ID Numbers ^ICMJE	59-1956-6-656
Study Sponsor ^ICMJE	Tufts University
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Tufts University
Verification Date	May 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP