Improvement of Endothelial Function by EGCG

February 2, 2016 updated by: Mario Lorenz, PhD, Charite University, Berlin, Germany

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Green tea beverage
200 mg EGCG as green tea beverage.
Dietary supplement: Green tea beverage
Active Comparator: Green tea extract
200 mg EGCG as green tea extract and same volume water as for tea beverage.
Dietary supplement: Green tea extract
Active Comparator: Epigallocatechin-3-gallate (EGCG)
200 mg EGCG and same volume water as for tea beverage.
Dietary supplement: EGCG
Placebo Comparator: Placebo (Water)
Same volume water as for all intervention arms.
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 hours after ingestion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 hours after ingestion
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.
2 hours after ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Mario Lorenz, PhD, Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria

August 9, 2012

First Posted (Estimate)

August 10, 2012

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Char-EGCG-FMD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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