Estimation of Plasma Folate Apparent Volume of Distribution in Adults (FOLCAN)
研究概览
详细说明
Bioavailability is a major determinant of nutritional status. In order to determine a safe level of folate fortification, its bioavailability must be assessed, so that risk-benefit analysis can be carried out. Recently, a mathematical model of folate true absorption which takes into account the liver first pass was devised (ref 1). In this model, the volume of distribution is a convenient method for describing how well a nutrient is removed from plasma and distributed into tissues.
In this study, volume of distribution will be more accurately estimated using an intravenous dose of labelled (13C5) dose of natural folate (5-methyltetrahydrofolic acid) in healthy adults aged 18-65, over a wide body mass index (BMI) range.
Healthy adults will be given an IV dose of a small amount of 13C5 5-methyltetrahydrofolic acid, and blood samples will be taken at regular time points via a cannula over a 2hr time period.
The primary objective is to estimate the sampled plasma pool volume of distribution in order to quantify the fraction of any folate test dose, or folate metabolites, appearing in systemic plasma circulation in future studies of bioavailability.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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Norfolk
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Norwich、Norfolk、英国、NR4 6JF
- Institute of Food Research
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Males and females
- Aged 18-65
- Body mass index above 19.5 and below 40
- Smokers and non-smokers
- Participation in the FolGene study
Exclusion Criteria:
- Pregnancy or been pregnant in last 12 months
- History of fits, seizures or blackouts
- Parallel participation in other research projects which invole dietary intervention and/or sampling of biological fluids/material which study nurses advice would affect either wellbeing of volunteer or the study data, apart from participation in the FolGene study
- Any person related to or living with a member of the study team
- Participation in another research project which involves blood sampling within the last 4 months unless total amount blood combined from both studies is less than 470ml
- Had donated blood within 16 weeks of starting the study
- Prescribed medication for epilepsy/seizures
- Diabetics
- History of any gastrointestinal disorder requiring medical treatment
- Any long term medical condition requiring active treatment which may affect volunteers wellbeing or the study data
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：IV dose of 5-methyltetrahydrofolic acid
IV test dose of 13C5-labelled 5-methyltetrahydrofolic acid to all eligible volunteers, followed by regular blood samplings over 2hr period taken via a cannula.
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one intravenous bolus dose of no more than 500nmole 13C5-labelled 5-methyltetrahydrofolic acid, followed by multiple blood samplings at regular time intervals.
Total 2hr "intervention".
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Estimation of sampled plasma pool volume of distribution for natural folates
大体时间：2 hours
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2 hours
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合作者和调查者
调查人员
- 首席研究员：Paul Finglas、Quadram Institute Bioscience
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IFR4/2008
- 08/H0310/154
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