Bioavailability of Golden Rice Carotenoids in Humans

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bioavailability of Golden Rice Carotenoids in Humans

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: golden rice
* Dietary Supplement: corn oil 0g
* Dietary Supplement: corn oil 10g
* Dietary Supplement: coren oil 5 g


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy health Exclusion Criteria: GI track problems

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Golden rice meal with 10g fat<br>10 g corn oil in the Golden Rice meal | Dietary Supplement: golden rice<br>* An acute dose of cooked golden rice containing   1 mg of ß-carotene<br>* Other names: golden rice carotenoids;Dietary Supplement: corn oil 10g<br>* 10g corn oil in the golden rice meal<br>|
| Other: Golden Rice with 0g fat<br>0g corn oil eating with the Golden Rice meal | Dietary Supplement: golden rice<br>* An acute dose of cooked golden rice containing   1 mg of ß-carotene<br>* Other names: golden rice carotenoids;Dietary Supplement: corn oil 0g<br>* 0 g of corn oil in the golden rice meal<br>|
| Other: Golden Rice meal with 5 g fat<br>5 g corn oil in the Golden Rice meal | Dietary Supplement: golden rice<br>* An acute dose of cooked golden rice containing   1 mg of ß-carotene<br>* Other names: golden rice carotenoids;Dietary Supplement: coren oil 5 g<br>* golden rice meal with 5 g corn oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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golden rice carotenoids, healthy volunteers, retinol equivalence