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
  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
Healthy
Dietary Supplement: golden rice
Dietary Supplement: corn oil 0g
Dietary Supplement: corn oil 10g
Dietary Supplement: coren oil 5 g

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

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: August 2004
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Golden rice meal with 10g fat
10 g corn oil 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
Dietary Supplement: corn oil 10g
10g corn oil in the golden rice meal
Golden Rice with 0g fat
0g corn oil eating with 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
Dietary Supplement: corn oil 0g
0 g of corn oil in the golden rice meal
Golden Rice meal with 5 g fat
5 g corn oil 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
Dietary Supplement: coren oil 5 g
golden rice meal with 5 g corn oil

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.
  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy health

Exclusion Criteria:

  • GI track problems
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00680355

Locations
United States, Massachusetts
USDA Human Nutrition Research Center on Aging at Tufts Uni
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Investigators
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: June 28, 2013
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 October 16, 2014