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临床试验/NCT00130585
NCT00130585已完成不适用

The Relative Bioavailability of Folate From a Mixed Diet Compared to Synthetic Folic Acid Using a Stable Isotope Method

Wageningen Centre for Food Sciences2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2005年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
2
主要终点
Bioavailability based on change in labelled folate concentration in plasma;

研究概览

简要总结

The main objectives of this project are:

  1. to determine the relative bioavailability of dietary folate from a total diet, compared with synthetic folic acid and
  2. to determine the bioavailability with a higher precision than previous methods.

The hypothesis is that the bioavailability of dietary folate within a confidence interval of +/-20% can be estimated.

详细描述

Folate plays a role in the prevention of certain birth defects and possibly also in prevention of neurocognitive diseases, cancer and cardiovascular disease. The proportion of dietary folate that is absorbed and becomes available for metabolic processes in the body has been estimated between 30 and 98%, but an accurate figure is lacking. Since subjects generally differ a lot in their folate or homocysteine response upon a change in dietary folate intake, the between-person variability in these responses is high. Therefore, bioavailability estimates derived from these responses have large confidence intervals. With this trial the researchers want to determine folate bioavailability with a higher precision than previous trials. A good estimate of folate bioavailability from the general diet is necessary to construct reliable dietary reference intakes for folate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Serum B12 >118pmol/L;
  • Serum creatinine <125micromol/L;
  • Plasma total homocysteine <26micromol/L.

排除标准

  • Cardiovascular disease, cancer, rheumatoid arthritis, epilepsy, gastro-intestinal disorders;
  • Use of drugs interfering with folate metabolism;
  • Use of B vitamins within the period three months prior to the study.
  • Body Mass Index (BMI) > 30

结局指标

主要结局

Bioavailability based on change in labelled folate concentration in plasma;

Bioavailability based on change in folate concentration in plasma

次要结局

  • Bioavailability based on change in concentration in plasma homocysteine

研究者

发起方
Wageningen Centre for Food Sciences
申办方类型
Other

研究点 (2)

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