Bioavailability of Golden Rice Carotenoids in Humans

• ClinicalTrials.gov Identifier: NCT00680355
• Recruitment Status: Completed
• First Posted: May 20, 2008
• Last Update Posted: July 1, 2013
• Sponsor: Tufts University
• Information provided by (Responsible Party): Guangwen Tang, Ph. D, Tufts University

Study Description

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

• 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

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

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

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

Criteria

Inclusion Criteria:

• healthy health

Exclusion Criteria:

• GI track problems

Contacts and Locations

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
• 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