Completed

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

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What is being tested

Green tea beverage

+ Green tea extract

+ EGCG

Dietary SupplementOther
Who is being recruted

Cardiovascular Diseases

From 20 to 50 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorCharite University, Berlin, Germany
Last updated: February 3, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01662232
Principal SponsorCharite University, Berlin, Germany
Last updated: February 3, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

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

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 20 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular Diseases

Criteria

4 inclusion criteria required to participate
20-50 years
BMI < 27 kg/m2
Cholesterol < 240 mg/dl
Male healthy volunteers
7 exclusion criteria prevent from participating
Alcohol abuse
Conditions with impaired endothelial function
Diabetes mellitus
Hypertension
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
200 mg EGCG as green tea beverage.

Group II

Active Comparator
200 mg EGCG as green tea extract and same volume water as for tea beverage.

Group III

Active Comparator
200 mg EGCG and same volume water as for tea beverage.

Group IV

Placebo
Same volume water as for all intervention arms.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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

Berlin, GermanyOpen Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin in Google Maps
CompletedOne Study Center