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临床试验/NCT00636038
NCT00636038已完成1 期

Bioavailability of Yellow Maize Carotenoids in Humans

Tufts University1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
8
试验地点
1
主要终点
Bioavailability of corn beta-carotene and its equivalency to provide vitamin A

研究概览

简要总结

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.

详细描述

  • 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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy subjects

排除标准

  • GI track problems

结局指标

主要结局

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

时间窗: one year

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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