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Completed

NCT Number: NCT00636038

Bioavailability of Yellow Maize Carotenoids in Humans

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.

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Key information

Conditions

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

National University of Science and Technology

Bulawayo, Zimbabwe

About this study

  • list item one ß-C in yellow maize

Pro-vitamin A carotenoids in plants are a major and safe vitamin A source for a vast population in the world. Even though, ß-carotene (ß-C) in vegetables has been considered as a safe vitamin A source, it is essential to determine the efficiency of provitamin A carotenoids in plant conversion to vitamin A. However, the bioavailability of vitamin A and carotenoids from food matrices has not been well studied due to the unavailability of isotopically labeled foods that can be fed to humans.

The main objective of this study is to investigate the bioavailability of ß-C in yellow maize and its bioconversion to retinol stored in the liver using 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, the deuterium labeled vitamin A that is derived from the labeled ß-C yellow maize will be traced after being eaten by a human subject. This will allow for quantitative determination of the vitamin A equivalence of high ß-C plant foods.

Eight men (> 40 years and < 70 y) who are healthy, non-smoking adults must have their 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 is a 50 day study during which dose 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, dose 2 will be used in evaluation of liver storage of vitamin A using 1 mg of 13C retinyl acetate. One blood sample (20 cc) will be drawn during the screening process. 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 plant food supplement to a vitamin A dose will be calculated based on the isotope reference method.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy subjects

Exclusion criteria

  • GI track problems

Treatment and study plan

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

Other names: staple food beta-carotene

Primary outcomes

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

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • National University of Science and Technology, Zimbabwe
  • Nutricia Research Fundation

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 14, 2008
Registry last updated
Mar 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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