Bioavailability of Golden Rice Carotenoids in Humans - Full Text View

Purpose

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	Intervention
Healthy	Dietary Supplement: golden rice Dietary Supplement: corn oil 0g Dietary Supplement: corn oil 10g Dietary Supplement: coren oil 5 g


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Bioavailability of Golden Rice Carotenoids in Humans

Resource links provided by NLM:

MedlinePlus related topics: Vitamin A

Drug Information available for: Corn oil

U.S. FDA Resources

Further study details as provided by Tufts University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]


Enrollment:	14
Study Start Date:	August 2004
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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:

To determine ß-carotene response kinetics following a meal of golden rice with 0, 5, or 10 g fat (butter);
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.

Eligibility


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

Criteria

Inclusion Criteria:

healthy health

Exclusion Criteria:

GI track problems

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00680355

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

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
Study First Received:	May 16, 2008
Last Updated:	June 28, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2016