Improvement of Endothelial Function by EGCG

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662232
• Other study ID #: Char-EGCG-FMD
• Status: Completed
• Phase: N/A
• First received: August 7, 2012
• Last updated: February 2, 2016
• Start date: August 2012
• Est. completion date: September 2013

Study information

• Verified date: February 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Green tea beverage

• Green tea extract

• EGCG

Other:
• Placebo

Locations

Country	Name	City	State
Germany	Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated dilation of the arteria brachialis	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	No
Secondary	Agonist-induced platelet aggregation in vitro	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	No
Secondary	Determination of plasma tea polyphenol levels	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	No