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Improvement of Endothelial Function by EGCG

The Role of EGCG in Different Application Forms on Flow-mediated Dilation in Healthy Volunteers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01662232
Enrollment
50
Registered
2012-08-10
Start date
2012-08-31
Completion date
2013-09-30
Last updated
2016-02-03

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

Conditions

Cardiovascular Diseases

Keywords

Green tea, EGCG, Cardiovascular diseases, Endothelial function, Flow-mediated dilation

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTGreen tea beverage
DIETARY_SUPPLEMENTGreen tea extract
DIETARY_SUPPLEMENTEGCG
OTHERPlacebo

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Flow-mediated dilation of the arteria brachialis2 hours after ingestionChange 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.

Secondary

MeasureTime frameDescription
Agonist-induced platelet aggregation in vitro2 hours after ingestionBlood 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.
Determination of plasma tea polyphenol levels2 hours after ingestionBlood 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.

Countries

Germany

Outcome results

None listed

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