Clinical Trials Directory

Trials / Completed

CompletedNCT00680355

Bioavailability of Golden Rice Carotenoids in Humans

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Tufts University · Academic / Other
Sex
All
Age
40 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTgolden riceAn acute dose of cooked golden rice containing \~ 1 mg of ß-carotene
DIETARY_SUPPLEMENTcorn oil 0g0 g of corn oil in the golden rice meal
DIETARY_SUPPLEMENTcorn oil 10g10g corn oil in the golden rice meal
DIETARY_SUPPLEMENTcoren oil 5 ggolden rice meal with 5 g corn oil

Timeline

Start date
2004-08-01
Primary completion
2012-08-01
Completion
2012-08-01
First posted
2008-05-20
Last updated
2013-07-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00680355. Inclusion in this directory is not an endorsement.