The Relative Bioavailability of Folate From a Mixed Diet Compared to Synthetic Folic Acid Using a Stable Isotope Method
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:
- to determine the relative bioavailability of dietary folate from a total diet, compared with synthetic folic acid and
- 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
- 是
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
