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Effect of Tea on Endothelial Function and Ischaemia-reperfusion Injury

Effect of Black Tea Consumption on Endothelial Function and Ischaemia-reperfusion Injury in Humans

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01660516
Enrollment
23
Registered
2012-08-08
Start date
2011-08-31
Completion date
2012-02-29
Last updated
2013-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemia Reperfusion Injury

Keywords

Camellia sinensis, flavonoids, cardiovascular risk, flow mediated dilation

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Unilever R&D
CollaboratorINDUSTRY
Radboud University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy volunteers : age 18-60 * All subjects: written informed consent

Exclusion criteria

* Smoking * History of any cardiovascular disease * Hypertension (in supine position: systole \>140 mmHg, diastole \>90 mmHg) * Diabetes Mellitus * Hyperlipidaemia (fasting total cholesterol \>6.5 mmol/L) * Chronic use of medication known to interfere with the cardiovascular system * Professional athletes * Alcohol consumption \>14 units/week * BMI \>30 kg/m2

Design outcomes

Primary

MeasureTime frameDescription
Change in Endothelial Function after ischaemia reperfusion injurythree weeksChange 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

Secondary

MeasureTime frameDescription
Change in baseline flow mediated dilation after water/tea consumptionthree weeksChange in baseline flow mediated dilation after water/tea consumption

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026