Bioavailability of Golden Rice Carotenoids in Humans

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT00680355
• Lead Sponsor: Tufts University

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.

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 Timeline

• Study Start: 2004-08
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-16
• Study First Posted: 2008-05-20
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-28
• Last Update Posted: 2013-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• healthy health

Exclusion Criteria

• GI track problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

USDA Human Nutrition Research Center on Aging at Tufts Uni; 🇺🇸 Boston, Massachusetts, United States