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Bioavailability of Golden Rice Carotenoids in Humans

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ClinicalTrials.gov Identifier: NCT00680355
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : July 1, 2013
Sponsor:
Information provided by (Responsible Party):
Guangwen Tang, Ph. D, Tufts University

Tracking Information
First Submitted Date  ICMJE May 16, 2008
First Posted Date  ICMJE May 20, 2008
Last Update Posted Date July 1, 2013
Study Start Date  ICMJE August 2004
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2008)
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 ]
Change History Complete list of historical versions of study NCT00680355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability of Golden Rice Carotenoids in Humans
Official Title  ICMJE Bioavailability of Golden Rice Carotenoids in Humans
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2013)
14
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2008)
6
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy health

Exclusion Criteria:

  • GI track problems
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00680355
Other Study ID Numbers  ICMJE 59-1956-6-656
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guangwen Tang, Ph. D, Tufts University
Study Sponsor  ICMJE Tufts University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guangwen Tang, Ph. D Tufts University
PRS Account Tufts University
Verification Date June 2013

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