跳至主要内容
临床试验/NCT00680355
NCT00680355已完成不适用

Bioavailability of Golden Rice Carotenoids in Humans

Tufts University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2004年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
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.

研究概览

简要总结

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.

详细描述

Recently, scientists have genetically engineered "golden rice" that contains 1.6 ug ß-carotene in a gram of dry rice (12). Since the vitamin A equivalency varies from 2 ug (oil dose) to 27 ug (vegetable) carotene to 1 retinol equivalent and the equivalency is matrix dependent, it is necessary to know what the vitamin A equivalency of golden rice beta-carotene is. The determination of the absorption and conversion of golden rice beta-carotene is of importance for designing food programs in many rice-eating regions of the world, where vitamin A deficiency is common.

To evaluate the absorption and intestinal conversion of rice beta-carotene after an acute dose of golden rice, an intrinsically labeled Golden Rice with a labeled reference dose of vitamin A are used. We propose to conduct a pilot study on the US adults with normal vitamin A status (n = 15).

The specific aims of this pilot study are:

  1. To determine ß-carotene response kinetics following a meal of golden rice with 0, 5, or 10 g fat (butter);
  2. To determine retinol kinetics from the golden rice and from the labeled vitamin A dose;
  3. To determine vitamin A value of golden rice ß-carotene in adults with normal vitamin A status. The determination of the absorption and conversion of golden rice ß-carotene is of importance for designing food programs in many rice-eating regions of the world, where vitamin A deficiency is common.

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
All
接受健康志愿者

入选标准

  • healthy health

排除标准

  • GI track problems

结局指标

主要结局

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.

时间窗: 33 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guangwen Tang, Ph. D

Senior Scientist

Tufts University

研究点 (2)

Loading locations...

相似试验

Bioavailability of Golden Rice Carotenoids in Humans | 临床试验