Ischaemia Reperfusion Injury Clinical Trial
Official title:
Effect of Black Tea Consumption on Endothelial Function and Ischaemia-reperfusion Injury in Humans
Tea consumption may impact upon the decrease in endothelial function after IR-injury.
However, no previous study directly examined the potential of tea to impact upon the change
in endothelial function after IR-injury.
The investigators hypothesize that tea consumption counteracts endothelial damage in
response to ischaemia reperfusion injury in healthy humans.
Rationale: Occlusion of an artery (causing ischemia) is a frequently reported condition,
e.g. myocardial infarction, cerebral infarction or during organ transplantations. The period
of ischemia will be followed by reperfusion (possibly after an operation). The ischaemic
period as well as the reperfusion are both associated with damage to the tissue, including
the endothelium. It is hypothesised that production of oxidative stress and reduced NO
bioactivity (through increased reactive oxygen production) during ischaemia and reperfusion
is involved in the development of tissue damage to the endothelium. Interventions that can
prevent or attenuate endothelial dysfunction in response to ischemia-reperfusion (IR)-injury
have a potential clinical relevance to prevent (complications of) cardiovascular disease.
Several studies have examined the effect of tea consumption on the endothelial function.
These studies demonstrated a dose-dependent improvement of tea to improve endothelial
function in healthy and diseased humans, possibly through the vasoactive effects of
flavonoids, which may involve increased nitric oxide bioactivity and inhibition of NADPH
oxidase. Based on the ability of flavonoids to decrease (the impact of) oxidative stress,
tea consumption may also impact upon the decrease in endothelial function after IR-injury.
However, no previous study directly examined the potential of tea to impact upon the change
in endothelial function after IR-injury.
Objective: To examine whether tea consumption counteracts endothelial damage in response to
ischaemia reperfusion injury in healthy humans.
Main study parameters: Change in endothelial function (measured with flow mediated dilation)
after ischaemia reperfusion injury (induced by 20 minutes ischemia and 20 min reperfusion)
with and without precedence of tea consumption.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Non-invasive cuff occlusion is used to examine endothelial function (5-minute
ischaemia) and produce the stimulus that induces ischaemia-reperfusion injury (20-minute
ischaemia). This repeated cuff inflation is non-invasive and not associated with a health
risk for the subject. Tea consumption is safe and, most likely, daily routine for most
participants. The only difference is that this study will monitor and instruct participants
regarding their tea consumption in the week preceding the tests. The volunteers will not
benefit directly from participating in this study.
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Observational Model: Case-Crossover, Time Perspective: Cross-Sectional
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03541239 -
Immune Modulation by Ischemic Pre-conditioning in Healthy Individuals: Intracellular Signalling in Regulatory Cells
|
N/A |