Metabolic Consequences of High-Dose Folic Acid Supplementation on Kinetics of 1-Carbon Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Plateau enrichment of infused amino acid tracers and related metabolites to quantify turnover rates of folate dependent pathways
研究概览
简要总结
Periconceptional supplementation with folic acid - the synthetic form of the B-vitamin folate - reduces the occurrence of adverse pregnancy outcomes such as spina bifida. The underlying biochemical mechanisms for how folic acid affects health outcomes however are unknown. The naturally occurring form 5-methyltetrahydrofolate (5-MTHF) is now available and discussed as an adequate substitute to folic acid. This study aims to determine the effect of folic acid compared to 5-MTHF on cellular mechanisms. Stable isotope tracer protocols will be used that allow determining the effect of folic acid on the dynamics of metabolic pathways in the human body.
Hypothesis: Supplementation with high-dose folic acid alters the turnover rate of folate dependent pathways in healthy humans; but 5-MTHF does not. Genetic variations in a key enzyme of the folate metabolism will aggravate the effect of folic acid on the metabolic pathways.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Generally healthy
- •Body mass index of between 19-24 kg/m2
- •Normal folate, vitamin B12, and B6 status
排除标准
- •Unable to swallow tablets
- •Unable to receive intravenous catheters
- •Use of vitamin supplements, amino acid or protein supplements for more than six months before study participation
- •Chronic consumption of a high-protein diet (e.g. Atkins Diet)
- •Medical conditions such as diabetes, asthma, cancer, cardiovascular disease, a history of neural tube defect (such as spina bifida) affected pregnancy, have had gastrointestinal surgery, abnormal kidney, thyroid function, or psychiatric illness, or any other chronic disease
- •Pregnancy or lactation
- •Smoking, use of recreational drugs, and/or consumption of more than one alcohol drink per day or more than seven per week.
- •Use of long-term prescription medication such as hormonal contraceptives, antidepressants, anticonvulsants, anticoagulants, or other chronic medication
- •Blood donation in the last three months prior to study start
- •Unable to provide informed consent, or unable to read and write English
- •Low compliance to intervention as determined by early steady-state or reduction in blood folate concentrations
结局指标
主要结局
Plateau enrichment of infused amino acid tracers and related metabolites to quantify turnover rates of folate dependent pathways
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
Yvonne Lamers
Principal Investigator
University of British Columbia