Improvement of Endothelial Function by EGCG

NCT ID: NCT01662232

Last Updated: 2016-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Green tea beverage

200 mg EGCG as green tea beverage.

Group Type ACTIVE_COMPARATOR

Green tea beverage

Intervention Type DIETARY_SUPPLEMENT

Green tea extract

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

Group Type ACTIVE_COMPARATOR

Green tea extract

Intervention Type DIETARY_SUPPLEMENT

Epigallocatechin-3-gallate (EGCG)

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

Group Type ACTIVE_COMPARATOR

EGCG

Intervention Type DIETARY_SUPPLEMENT

Placebo (Water)

Same volume water as for all intervention arms.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Green tea beverage

Intervention Type DIETARY_SUPPLEMENT

Green tea extract

Intervention Type DIETARY_SUPPLEMENT

EGCG

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Mario Lorenz, PhD

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mario Lorenz, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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Char-EGCG-FMD

Identifier Type: -

Identifier Source: org_study_id

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