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Bioavailability of Yellow Maize Carotenoids in Humans

NCT00636038 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2008-03-14

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

corn beta-carotene

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

Sponsors & Collaborators

  • Nutricia Research Fundation

    collaborator OTHER

  • National University of Science and Technology, Zimbabwe

    collaborator OTHER

  • Tufts University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Zimbabwe

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00636038 on ClinicalTrials.gov