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临床试验/NCT00680277
NCT00680277已完成1 期

Vitamin A Value of Spirulina Carotenoids in Humans

Tufts University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2004年4月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
20
试验地点
2
主要终点
The enrichment of spirulina ß-carotene and its cleavage product vitamin A were tracked after taken the oral dose of intrinsically labeled spirulina.

研究概览

简要总结

The goal of this protocol is to determine the vitamin A value (equivalence) of spirulina. The investigation will use intrinsically deuterium labeled spirulina and an isotope vitamin A reference dose, 13C10- retinyl acetate (13C10 RAc), in males (n=20). Up to 45 blood samples (10 ml/sample) will be collected from each subject over a two-month period to evaluate the bioavailability and bioconversion of spirulina ß-carotene to vitamin A.

详细描述

By utilizing novel stable isotope dilution techniques recently developed in our laboratory, we will trace deuterium labeled ß-carotene in intrinsically labeled spirulina, which is harvested from a hydroponic system. In the mean time, we will track 13C10 labeled vitamin A in humans. In this way we will determine absorption of ß-carotene from spirulina matrix and the conversion of the spirulina ß-Carotene to retinol. This will enable us quantitatively determine the vitamin A equivalence of spirulina.

The specific aims of this study are:

  1. To determine labeled ß-C blood response kinetics following an acute dose of intrinsically labeled spirulina;
  2. To determine labeled retinol blood response from the intrinsically labeled spirulina;
  3. To determine 13C10 retinol blood response from the isotope reference material 13C10 retinyl acetate;
  4. To determine s spirulina-vitamin A equivalence.

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 volunteer

排除标准

  • Not has GI track problems
  • Any medical condition that will affect the intestinal absorption

研究组 & 干预措施

1

Experimental

干预措施: spirulina ß-carotene (Dietary Supplement)

2

Experimental

干预措施: spirulina ß-carotene (Dietary Supplement)

结局指标

主要结局

The enrichment of spirulina ß-carotene and its cleavage product vitamin A were tracked after taken the oral dose of intrinsically labeled spirulina.

时间窗: 51 days

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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