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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | golden rice | An acute dose of cooked golden rice containing \~ 1 mg of ß-carotene |
| DIETARY_SUPPLEMENT | corn oil 0g | 0 g of corn oil in the golden rice meal |
| DIETARY_SUPPLEMENT | corn oil 10g | 10g corn oil in the golden rice meal |
| DIETARY_SUPPLEMENT | coren oil 5 g | golden 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.