Bioavailability of Yellow Maize Carotenoids in Humans

NCT00636038 | Completed Phase 1

• 1 other identifier: 2007-E6
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis is that high ß-C yellow maize can provide vitamin A efficiently. \- list item one ß-C in yellow maize The study will use stable isotope labeled high ß-C yellow maize and vitamin A in a well-nourished population by utilizing stable isotope dilution techniques. In this project, deuterium labeled vitamin A that is derived from the labeled ß-C yellow maize will be traced after being eaten by a human subject. Eight men (\> 40 years and \< 70 y) who are healthy, non-smoking,body weight within 20% of standard weight for height (Metropolitan) and not having taken vitamin A or ß-C supplements within the last month will be recruited as volunteers. This study will last for 50 days during which at day 1, cooked labeled yellow maize paste (porridge) equal to a total of \~ 2 bowls cooked yellow maize (from 100 - 200 g dry weight) containing \~ 1 mg ß-C will be taken by each volunteer. On day 8, a labeled vitamin A (1 mg of 13C retinyl acetate) in oil dose will be used in evaluation of liver storage of vitamin A. Forty six blood samples (460 cc) will be taken during the study which will be analyzed for serum carotenoids and retinoids using HPLC and mass spectrometry techniques. The serum concentration and isotope ratio of ß-C and retinol will be determined. Serum enrichment curve following each oral dose will be studied. The area under the curve (AUC) of retinol-d4 and labeled retinol from the reference dose in serum samples will be determined and compared. The equivalence of a high ß-C corn meal to vitamin A will be calculated based on the isotope reference method to determine the efficiency of corn ß-C to provide vitamin A.

Conditions

Vitamin A Status

Keywords

beta-carotene; yellow maize; vitamin A

Outcome Measures

Primary Outcomes (1)

• Bioavailability of corn beta-carotene and its equivalency to provide vitamin A

  one year

Interventions

corn beta-carotene DIETARY_SUPPLEMENT

yellow corn beta-carotene in a 1 mg level to be taken as corn porridge in one meal by volunteers

Also known as: staple food beta-carotene

Eligibility Criteria

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

You may qualify if:

• healthy subjects

You may not qualify if:

• GI track problems

Sponsors & Collaborators

• Tufts University: lead
• Nutricia Research Fundation: collaborator
• National University of Science and Technology, Zimbabwe: collaborator

Study Sites (1)

National University of Science and Technology

Bulawayo, Zimbabwe

Location

Related Publications (1)

• Muzhingi T, Gadaga TH, Siwela AH, Grusak MA, Russell RM, Tang G. Yellow maize with high beta-carotene is an effective source of vitamin A in healthy Zimbabwean men. Am J Clin Nutr. 2011 Aug;94(2):510-9. doi: 10.3945/ajcn.110.006486. Epub 2011 Jun 29.

  PMID: 21715509 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 14, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 14, 2008

Record last verified: 2008-03

Locations

ZI (1)