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临床试验/NCT05987566
NCT05987566已完成不适用

Chronobiology of Meal Timing: Effects on Vascular and Renal Function

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年9月11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
15
试验地点
2
主要终点
Urinary sodium excretion and markers of kidney injury

研究概览

简要总结

The purpose of this study us to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.

详细描述

Despite advancements in pharmacologic antihypertensives, hypertension currently affects 1 in 3 Americans and accounts for more than $50 billion of health care spending. Importantly, hypertension is the leading cause of cardiovascular (CVD) and kidney diseases (CKD). As a result, the AHA/ACC lowered the diagnostic criteria for hypertension to encourage earlier preventative lifestyle intervention. There is a critical need to identify and implement novel lifestyle interventions in individuals with early-stage hypertension to prevent the subsequent development of CVD and CKD. Chronotherapy that aligns behavioral cues (such as time of eating) with the body's internal biological clocks, has gained much attention as a potential strategy to prevent and manage hypertension, however, the underlying mechanisms are not yet fully understood. The purpose of this study is to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men and Women aged 18-45 years
  • Elevated (SBP 120-129; DBP <80 mmHg) or stage 1 hypertension (SBP 130-139; DBP 80-89 mmHg)

排除标准

  • History of chronic disease (CV, lung, cancer, renal, sleep apnea, diabetes, autoimmune)
  • Anti-hypertensive medication use
  • Currently pregnant or lactating
  • Current shift worker
  • Travel >3 time zones four weeks before the start of the study or during the study
  • Practiced intermittent fasting in past six months
  • Current nicotine use
  • Current hormone replacement therapy
  • Current melatonin use
  • Current use of antioxidants and unwilling to stop taking them for the duration of the study
  • Unable to provide informed consent

结局指标

主要结局

Urinary sodium excretion and markers of kidney injury

时间窗: 24 hours

Day and nocturnal urinary sodium, NGAL and KIM-1

次要结局

  • Macrovascular function(At baseline and after each 24hour experimental arm)
  • 24hr ambulatory blood pressure(24 Hours)
  • Microvascular function(At baseline and after each 24hour experimental arm)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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