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NCT Number: NCT01662232

Improvement of Endothelial Function by EGCG

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green tea beverage

Dietary Supplement

Green Tea Extract

Dietary Supplement

EGCG

Dietary Supplement

Placebo

Other

Primary outcomes

  1. Flow-mediated dilation of the arteria brachialis

    Time frame: 2 hours after ingestion

    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.

Secondary outcomes

  1. Agonist-induced platelet aggregation in vitro

    Time frame: 2 hours after ingestion

    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.

  2. Determination of plasma tea polyphenol levels

    Time frame: 2 hours after ingestion

    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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 10, 2012
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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