Bioavailability of Golden Rice Carotenoids in Humans
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| ClinicalTrials.gov Identifier: NCT00680355 |
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Recruitment Status :
Completed
First Posted : May 20, 2008
Last Update Posted : July 1, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy | Dietary Supplement: golden rice Dietary Supplement: corn oil 0g Dietary Supplement: corn oil 10g Dietary Supplement: coren oil 5 g | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Bioavailability of Golden Rice Carotenoids in Humans |
| Study Start Date : | August 2004 |
| Actual Primary Completion Date : | August 2012 |
| Actual Study Completion Date : | August 2012 |
| Arm | Intervention/treatment |
|---|---|
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Golden rice meal with 10g fat
10 g corn oil in the Golden Rice meal
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Dietary Supplement: golden rice
An acute dose of cooked golden rice containing ~ 1 mg of ß-carotene
Other Name: golden rice carotenoids Dietary Supplement: corn oil 10g 10g corn oil in the golden rice meal |
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Golden Rice with 0g fat
0g corn oil eating with the Golden Rice meal
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Dietary Supplement: golden rice
An acute dose of cooked golden rice containing ~ 1 mg of ß-carotene
Other Name: golden rice carotenoids Dietary Supplement: corn oil 0g 0 g of corn oil in the golden rice meal |
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Golden Rice meal with 5 g fat
5 g corn oil in the Golden Rice meal
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Dietary Supplement: golden rice
An acute dose of cooked golden rice containing ~ 1 mg of ß-carotene
Other Name: golden rice carotenoids Dietary Supplement: coren oil 5 g golden rice meal with 5 g corn oil |
- 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 ]
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| Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy health
Exclusion Criteria:
- GI track problems
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680355
| United States, Massachusetts | |
| USDA Human Nutrition Research Center on Aging at Tufts Uni | |
| Boston, Massachusetts, United States, 02111 | |
| Principal Investigator: | Guangwen Tang, Ph. D | Tufts University |
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 |
| First Posted: | May 20, 2008 Key Record Dates |
| Last Update Posted: | July 1, 2013 |
| Last Verified: | June 2013 |
Keywords provided by Guangwen Tang, Ph. D, Tufts University:
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golden rice carotenoids healthy volunteers retinol equivalence |
Additional relevant MeSH terms:
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Carotenoids Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |