Bioavailability of Golden Rice Carotenoids in Humans
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Dietary Supplement: golden rice |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Bioavailability of Golden Rice Carotenoids in Humans |
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
using 10 g fat in the Golden Rice meal
|
Dietary Supplement: golden rice
An acute dose of cooked golden rice containing ~ 1 mg of ß-carotene
Other Name: golden rice carotenoids
|
|
No Intervention: 2
0g dietary fat (butter) eating with the Golden Rice meal
|
|
|
No Intervention: 3
using 5 g fat in the Golden Rice meal
|
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:
- 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.
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy health
Exclusion Criteria:
- GI track problems
Contacts and Locations| Contact: guangwen tang, Ph. D. | 617-556-3236 | guangwen.tang@tufts.edu |
| Contact: Lisa Ceglia, M.D. | 617-556-3085 | lisa.Ceglia@tufts.edu |
| United States, Massachusetts | |
| USDA Human Nutrition Research Center on Aging at Tufts Uni | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Guangwen Tang, Ph.D 617-556-3236 guangwen.tang@tufts.edu | |
| Contact: Lisa Ceglia, M.D. 617-556-3085 lisa.ceglia@tufts.edu | |
| Principal Investigator: Guangwen Tang, Ph. D | |
| Principal Investigator: | Guangwen Tang, Ph. D | Tufts University |
More Information
No publications provided by Tufts University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Guangwen Tang, Ph. D, Senior Scientist, Tufts University |
| ClinicalTrials.gov Identifier: | NCT00680355 History of Changes |
| Other Study ID Numbers: | 59-1956-6-656 |
| Study First Received: | May 16, 2008 |
| Last Updated: | April 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Tufts University:
|
golden rice carotenoids healthy volunteers retinol equivalence |
Additional relevant MeSH terms:
|
Carotenoids Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013