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Completed

NCT Number: NCT00680355

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.

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Key information

Conditions

Healthy

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Human Nutrition Research Center on Aging at Tufts Uni

Boston, Massachusetts, 02111, United States

About this study

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:

  • To determine ß-carotene response kinetics following a meal of golden rice with 0, 5, or 10 g fat (butter);
  • To determine retinol kinetics from the golden rice and from the labeled vitamin A dose;
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy health

Exclusion criteria

  • GI track problems

Treatment and study plan

golden rice

Dietary Supplement

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

Other names: golden rice carotenoids

corn oil 0g

Dietary Supplement

0 g of corn oil in the golden rice meal

corn oil 10g

Dietary Supplement

10g corn oil in the golden rice meal

coren oil 5 g

Dietary Supplement

golden rice meal with 5 g corn oil

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
May 20, 2008
Registry last updated
Jul 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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