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Bioavailability of Golden Rice Carotenoids in Humans

Bioavailability of Golden Rice Carotenoids in Humans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00680355
Enrollment
14
Registered
2008-05-20
Start date
2004-08-31
Completion date
2012-08-31
Last updated
2013-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

golden rice carotenoids, healthy volunteers, retinol equivalence

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.

Interventions

DIETARY_SUPPLEMENTgolden rice

An acute dose of cooked golden rice containing \ 1 mg of ß-carotene

DIETARY_SUPPLEMENTcorn oil 0g

0 g of corn oil in the golden rice meal

DIETARY_SUPPLEMENTcorn oil 10g

10g corn oil in the golden rice meal

DIETARY_SUPPLEMENTcoren oil 5 g

golden rice meal with 5 g corn oil

Sponsors

Tufts University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy health

Exclusion criteria

* GI track problems

Design outcomes

Primary

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026