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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy health

Exclusion Criteria:

GI track problems

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Tufts University

Additional 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	Pharmacologic Actions Physiological Effects of Drugs Protective Agents

ClinicalTrials.gov processed this record on March 03, 2015