Bioavailability of Golden Rice Carotenoids in Humans

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: golden rice; Dietary Supplement: corn oil 10g; Dietary Supplement: corn oil 0g; Dietary Supplement: coren oil 5 g

• 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

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Exclusion Criteria

• GI track problems

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Golden rice meal with 10g fat	golden rice	10 g corn oil in the Golden Rice meal
Golden rice meal with 10g fat	corn oil 10g	10 g corn oil in the Golden Rice meal
Golden Rice with 0g fat	golden rice	0g corn oil eating with the Golden Rice meal
Golden Rice with 0g fat	corn oil 0g	0g corn oil eating with the Golden Rice meal
Golden Rice meal with 5 g fat	golden rice	5 g corn oil in the Golden Rice meal
Golden Rice meal with 5 g fat	coren oil 5 g	5 g corn oil in the Golden Rice meal

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