Improvement of Endothelial Function by EGCG

Charite University, Berlin, Germany50 enrolled

Overview

Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired endothelial function (assessed as flow-mediated dilation) represents an early marker for later cardiovascular events. Epidemiological and experimental studies suggest that consumption of tea is associated with lower progression of atherosclerosis and reduced cardiovascular mortality. Tea contains high amounts of polyphenols with important biological activities. The green tea catechin epigallocatechin-3-gallate (EGCG) is the most potent physiologically active compound in vitro. However, little is known about its contribution to beneficial effects of tea in vivo. In this crossover study the impact of a single dose of EGCG applied in different forms (green tea beverage, green tea extract and EGCG) on flow-mediated dilation is investigated in healthy volunteers two hours after ingestion. The amount of EGCG (200 mg) corresponds to appr. 0.5 L of green tea. The results of the study will elucidate the contribution of EGCG in cardiovascular protective effects of green tea in vivo. The outcomes will provide insights about the role of EGCG in different application forms to improvements of endothelial function in humans.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Cardiovascular Diseases

Interventions

Green tea beverageDIETARY_SUPPLEMENT

Green tea extractDIETARY_SUPPLEMENT

EGCGDIETARY_SUPPLEMENT

PlaceboOTHER

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male healthy volunteers * 20-50 years * BMI \< 27 kg/m2 * Cholesterol \< 240 mg/dl Exclusion Criteria: * Diabetes mellitus * Hypertension * Conditions with impaired endothelial function * Smoking * Regular drug use * Alcohol abuse * Regular tea drinkers

Locations (1)

Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

Flow-mediated dilation of the arteria brachialis

Change in flow-mediated dilation (in %) of the arteria brachialis after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG is assessed by vascular ultrasound.

Time frame: 2 hours after ingestion

Secondary Outcomes

Agonist-induced platelet aggregation in vitro

Blood is drawn two hours after consumption and the effects on in vitro agonist-induced platelet aggregation after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG are measured.

Time frame: 2 hours after ingestion

Determination of plasma tea polyphenol levels

Blood is drawn two hours after consumption and plasma concentrations of tea polyphenols are measured after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG by HPLC.

Time frame: 2 hours after ingestion

Data from ClinicalTrials.gov

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