Bioavailability of Golden Rice Carotenoids in Humans

NCT00680355 | Completed

• 1 other identifier: 59-1956-6-656
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

golden rice carotenoids; healthy volunteers; retinol equivalence

Outcome Measures

Primary Outcomes (1)

• 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.

  33 days

Study Arms (3)

Golden rice meal with 10g fat

OTHER

10 g corn oil in the Golden Rice meal

Dietary Supplement: golden rice; Dietary Supplement: corn oil 10g

Golden Rice with 0g fat

OTHER

0g corn oil eating with the Golden Rice meal

Dietary Supplement: golden rice; Dietary Supplement: corn oil 0g

Golden Rice meal with 5 g fat

OTHER

5 g corn oil in the Golden Rice meal

Dietary Supplement: golden rice; Dietary Supplement: coren oil 5 g

Interventions

golden rice DIETARY_SUPPLEMENT

An acute dose of cooked golden rice containing \~ 1 mg of ß-carotene

Also known as: golden rice carotenoids

Golden Rice meal with 5 g fat; Golden Rice with 0g fat; Golden rice meal with 10g fat

corn oil 0g DIETARY_SUPPLEMENT

0 g of corn oil in the golden rice meal

Golden Rice with 0g fat

corn oil 10g DIETARY_SUPPLEMENT

10g corn oil in the golden rice meal

Golden rice meal with 10g fat

coren oil 5 g DIETARY_SUPPLEMENT

golden rice meal with 5 g corn oil

Golden Rice meal with 5 g fat

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy health

You may not qualify if:

• GI track problems

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

USDA Human Nutrition Research Center on Aging at Tufts Uni

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• 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.

  PMID: 19369372 DERIVED

MeSH Terms

Interventions

Corn Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Guangwen Tang, Ph. D

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 20, 2008
• Study Start: August 1, 2004
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 1, 2013

Record last verified: 2013-06

Locations

US (1)