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临床试验/NCT04948086
NCT04948086已完成不适用

Blood Pressure Lowering Effect of B-vitamins in Adults With a Genetic Pre-disposition to Elevated Blood Pressure.

University of Ulster1 个研究点 分布在 1 个国家目标入组 498 人开始时间: 2011年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
498
试验地点
1
主要终点
Blood pressure

研究概览

简要总结

Approximately 12% of the world's population have a have a common C677T polymorphism in the gene encoding the folate metabolising enzyme, methylenetetrahydrofolate reductase (MTHFR). Homozygosity for the polymorphism (TT genotype) appears to result in an increased requirement for the B-vitamins folic acid and riboflavin and more importantly results in an increased risk of developing high blood pressure (BP). Previous work from our Centre has demonstrated significantly higher BP in those with the TT genotype. This work has been conducted in cohorts with premature cardiovascular disease (CVD) and hypertension without overt CVD, but the effect in younger, healthier individuals is unexplored. To date our studies have also focused on BP as the primary outcome, but newer markers of vascular health including central pressure and hemodynamics have emerged as superior prognostic indicators of CVD. The effect of the TT genotype on these measures is thus an important area for investigation and may help us understand the mechanism linking the genotype with BP, which is currently unknown. As adults with the TT genotype appear to have increased requirements for riboflavin and folic acid, and BP in TT adults appears to be riboflavin dependent, the influence of these vitamins on central measures is an area for consideration. Study Design This is an observational study investigating the blood pressure profiles of healthy adults aged 18-65 years, stratified by MTHFR genotype. Apparently healthy adults will be recruited from workplaces and the general community across Northern Ireland and screened for the polymorphism via buccal swab. Those with the TT genotype and a similar number of non-TT (i.e. CC/CT) genotype individuals will be contacted and asked to come to attend a one-off appointment. Brachial BP will be assessed by an electronic BP monitor, central BP and central haemodynamics (augmentation index, augmentation pressure and pulse wave velocity) will be assessed by SphygmoCor XCEL. In addition, anthropometric measurements, health and lifestyle information and a blood sample will be obtained. Data will be statistically analysed using SPSS software to if determine differences between gentoype groups exist.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Pre-screened for MTHFR 677TT genotype
  • Aged at least 18 years old

排除标准

  • Younger than 18 years

结局指标

主要结局

Blood pressure

时间窗: One day, one measurement

Office blood pressure

次要结局

  • Pulse wave velocity(One day, one measurement)
  • Brachial blood pressure(One day, one measurement)
  • Central blood pressure(One day, one measurement)
  • One-carbon metabolite status(One day, one measurement)
  • Pulse wave analysis(One day, one measurement)
  • Folate status(One day, one measurement)
  • PLP status(One day, one measurement)
  • Homocysteine status(One day, one measurement)
  • Riboflavin status(One day, one measurement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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