Bioavailability of Golden Rice Carotenoids in Humans

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: golden rice; Dietary supplement: corn oil 10g; Dietary supplement: corn oil 0g; Dietary supplement: coren oil 5 g

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy health

Exclusion Criteria:

• GI track problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: golden rice carotenoids; Dietary supplement: corn oil 10g; 10g corn oil in the golden rice meal
Other: 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 Names: golden rice carotenoids; Dietary supplement: corn oil 0g; 0 g of corn oil in the golden rice meal
Other: 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 Names: golden rice carotenoids; Dietary supplement: coren oil 5 g; golden rice meal with 5 g corn oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	33 days

Collaborators and Investigators

• Sponsor: Tufts University

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: May 16, 2008
• First Submitted That Met QC Criteria: May 16, 2008
• First Posted (Estimate): May 20, 2008

Study Record Updates

• Last Update Posted (Estimate): July 1, 2013
• Last Update Submitted That Met QC Criteria: June 28, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: healthy volunteers; golden rice carotenoids; retinol equivalence
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Carotenoids
• Other Study ID Numbers: 59-1956-6-656