Improvement of Endothelial Function by EGCG

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mario Lorenz, PhD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01662232
First received: August 7, 2012
Last updated: September 30, 2013
Last verified: September 2013

August 7, 2012
September 30, 2013
August 2012
September 2013   (final data collection date for primary outcome measure)
Flow-mediated dilation of the arteria brachialis [ Time Frame: 2 hours after ingestion ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01662232 on ClinicalTrials.gov Archive Site
  • Agonist-induced platelet aggregation in vitro [ Time Frame: 2 hours after ingestion ] [ Designated as safety issue: No ]
    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.
  • Determination of plasma tea polyphenol levels [ Time Frame: 2 hours after ingestion ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Improvement of Endothelial Function by EGCG
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Cardiovascular Diseases
  • Dietary Supplement: Green tea beverage
  • Dietary Supplement: Green tea extract
  • Dietary Supplement: EGCG
  • Active Comparator: Green tea beverage
    200 mg EGCG as green tea beverage.
    Intervention: 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.
    Intervention: Dietary Supplement: Green tea extract
  • Active Comparator: Epigallocatechin-3-gallate (EGCG)
    200 mg EGCG and same volume water as for tea beverage.
    Intervention: Dietary Supplement: EGCG
  • Placebo Comparator: Water
    Same volume water as for all intervention arms.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Male
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01662232
Char-EGCG-FMD
No
Mario Lorenz, PhD, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Mario Lorenz, PhD Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin, Germany
Charite University, Berlin, Germany
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP