Bioavailability of Golden Rice Carotenoids in Humans

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Healthy	Dietary Supplement: golden rice; Dietary Supplement: corn oil 0g; Dietary Supplement: corn oil 10g; Dietary Supplement: coren oil 5 g	Not Applicable

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 = 15).

The specific aims of this pilot study are:

1. To determine ß-carotene response kinetics following a meal of golden rice with 0, 5, or 10 g fat (butter);
2. To determine retinol kinetics from the golden rice and from the labeled vitamin A dose;
3. 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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	14 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	Bioavailability of Golden Rice Carotenoids in Humans
Study Start Date :	August 2004
Actual Primary Completion Date :	August 2012
Actual Study Completion Date :	August 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Golden rice meal with 10g fat; 10 g corn oil in the Golden Rice meal	Dietary Supplement: golden rice; An acute dose of cooked golden rice containing ~ 1 mg of ß-carotene; Other Name: golden rice carotenoids Dietary Supplement: corn oil 10g; 10g corn oil in the golden rice meal
Golden Rice with 0g fat; 0g corn oil eating with the Golden Rice meal	Dietary Supplement: golden rice; An acute dose of cooked golden rice containing ~ 1 mg of ß-carotene; Other Name: golden rice carotenoids Dietary Supplement: corn oil 0g; 0 g of corn oil in the golden rice meal
Golden Rice meal with 5 g fat; 5 g corn oil in the Golden Rice meal	Dietary Supplement: golden rice; An acute dose of cooked golden rice containing ~ 1 mg of ß-carotene; Other Name: golden rice carotenoids Dietary Supplement: coren oil 5 g; golden rice meal with 5 g corn oil

Outcome Measures

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Primary Outcome Measures :

1. The enrichment of labeled golden rice β-carotene and its conversion to labeled retinol in serum samples after the golden rice meal with 0, 5, or 10 g fat (butter) as compared to the reference dose of vitamin A that is labeled differently. [ Time Frame: 33 days ]

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• healthy health

Exclusion Criteria:

• GI track problems

Contacts and Locations

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Locations

United States, Massachusetts
USDA Human Nutrition Research Center on Aging at Tufts Uni
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

Tufts University

Investigators

Principal Investigator:	Guangwen Tang, Ph. D	Tufts University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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. doi: 10.3945/ajcn.2008.27119. Epub 2009 Apr 15.

Responsible Party:	Guangwen Tang, Ph. D, Senior Scientist, Tufts University
ClinicalTrials.gov Identifier:	NCT00680355 History of Changes
Other Study ID Numbers:	59-1956-6-656
First Posted:	May 20, 2008
Last Update Posted:	July 1, 2013
Last Verified:	June 2013

Keywords provided by Guangwen Tang, Ph. D, Tufts University:

golden rice carotenoids; healthy volunteers; retinol equivalence

Additional relevant MeSH terms:

Carotenoids; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs