Bioavailability of Golden Rice Carotenoids in Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guangwen Tang, Ph. D, Tufts University
ClinicalTrials.gov Identifier:
NCT00680355
First received: May 16, 2008
Last updated: June 28, 2013
Last verified: June 2013

May 16, 2008
June 28, 2013
August 2004
August 2012   (final data collection date for primary outcome measure)
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 ]
The enrichment of labeled golden rice β-carotene and its conversion to labeled retinol in serum samples after the golden rice meal as compared to the reference dose of vitamin A that is labeled differently. [ Time Frame: 33 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00680355 on ClinicalTrials.gov Archive Site
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Bioavailability of Golden Rice Carotenoids in Humans
Bioavailability of Golden Rice Carotenoids in Humans

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.

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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
  • Golden rice meal with 10g fat
    10 g corn oil in the Golden Rice meal
    Interventions:
    • Dietary Supplement: golden rice
    • Dietary Supplement: corn oil 10g
  • Golden Rice with 0g fat
    0g corn oil eating with the Golden Rice meal
    Interventions:
    • Dietary Supplement: golden rice
    • Dietary Supplement: corn oil 0g
  • Golden Rice meal with 5 g fat
    5 g corn oil in the Golden Rice meal
    Interventions:
    • Dietary Supplement: golden rice
    • Dietary Supplement: coren oil 5 g
Tang G, Qin J, Dolnikowski GG, Russell RM, Grusak MA. Golden Rice is an effective source of vitamin A. Am J Clin Nutr. 2009 Jun;89(6):1776-83. doi: 10.3945/ajcn.2008.27119. Epub 2009 Apr 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy health

Exclusion Criteria:

  • GI track problems
Both
40 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00680355
59-1956-6-656
No
Not Provided
Not Provided
Guangwen Tang, Ph. D, Tufts University
Tufts University
Not Provided
Principal Investigator: Guangwen Tang, Ph. D Tufts University
Tufts University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP