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临床试验/NCT05220059
NCT05220059Unknown不适用

Effect of Polyphenol Extract on Cardiovascular Health Markers: a 4 Way Randomised Crossover Study

University of Ulster2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Flow Mediated Dilation

研究概览

简要总结

Endothelial dysfunction is an early predictor of cardiovascular events in at-risk patients. It is characterized by impaired endothelium-dependent dilation and is primarily caused by reduced nitric oxide bioavailability secondary to oxidative stress and inflammation. Finding dietary/dietary supplement-oriented approaches to improving endothelial function is of public health interest.

A randomized double-blind placebo controlled 4-way crossover study will be conducted to determine if acute consumption of a proprietary polyphenol extract (156 mg / 222 mg / 333 mg) will have a dose dependent response on endothelium-dependent flow-mediated dilation (ED-FMD) in fasting conditions, in comparison to a placebo (maltodextrin) in male smokers (20 - 45 years; n=20).FMD and blood pressure will be assessed at 0 & 2 hour timepoints following consumption of a single dose of polyphenol extract, accompanying blood samples will be collected to assess a range of endpoints including nitric oxide metabolites, angiotensin and polyphenols metabolites. Endothelium-independent vasodilation will also be measured 2 hours post consumption.

研究设计

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

盲法说明

Double-blinded

入排标准

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

入选标准

  • At least two of the following risk markers; a BMI 25-30, waist circumference >94 cm, high normal blood pressure defined as either systolic 85-89 mmHg or diastolic 130-139 mmHg and have a normal ECG.

排除标准

  • An individual who has tested positive (self reported) 2 weeks before the study period.
  • A COVID-19 vaccinated individual who while receive the 1st or 2nd dose or booster 2 weeks before V0 or during the study period, due to the potential interaction of vaccine on markers assessed

结局指标

主要结局

Flow Mediated Dilation

时间窗: Change over 2 hours post dose

Acute change in endothelium-dependent flow-mediated dilation

次要结局

  • Diastolic blood pressure(Change over 2 hours post dose)
  • Endothelium-independent vasodilation(Change after 2 hours post dose)
  • Systolic blood pressure(Change over 2 hours post dose)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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