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临床试验/NCT05488106
NCT05488106Unknown不适用

Intervention With Riboflavin to Improve Vascular Health and ENdothelial Functioning in Genetically at- Risk Adults (InteRVENE Study)

University of Ulster2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
Diastolic blood pressure

研究概览

简要总结

High blood pressure is the leading risk factor for heart disease and stroke. Approximately 12% of the population have a particular genetic factor (known as the TT genotype) which increases the risk of high blood pressure. Previous studies conducted at this centre have shown that taking the B-vitamin riboflavin, for up to 3 months, decreases blood pressure in adults with the TT genotype. It is currently not known how riboflavin lowers blood pressure in those with the TT genotype but it could be as a result of altering blood levels of nitric oxide. Nitric oxide causes blood vessels to expand, leading to improved blood vessel function, an important predictor of cardiovascular health. However, the effect of riboflavin supplementation on nitric oxide and blood vessel function has not been previously studied. Furthermore, it is unclear whether taking riboflavin over a shorter period of time or at doses higher than 1.6 mg/d can also lower blood pressure and improve blood vessel function in this at risk group. Therefore, the aim of this study is to assess the effects of riboflavin supplementation on blood pressure, biomarkers of nitric oxide bioavailability and blood vessel function. It is hypothesised that riboflavin supplementation will increase nitric oxide bioavailability, leading to reduced blood pressure and improved blood vessel function and, and that a higher riboflavin dose will lead to greater reductions in blood pressure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Aged 60 years and below
  • Pre-screened for MTHFR 677TT genotype (TTs and CCs individuals only invited)

排除标准

  • Consumer of B-vitamin supplements
  • Consuming medication that interferes with B-vitamin metabolism

结局指标

主要结局

Diastolic blood pressure

时间窗: Change over 16 weeks

Branchial blood pressure

Systolic blood pressure

时间窗: Change over 16 weeks

Branchial blood pressure

次要结局

  • Endothelial function(Change over 16 weeks)
  • Erythrocyte glutathione reductase activation coefficient (EGRac)(Vitamin B2 marker)(Change over 16 weeks)
  • Nitric oxide bioavailability(Change over 16 weeks)
  • Pyridoxal phosphate (Vitamin B6 marker)(Change over 16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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