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
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Dietary Supplement: Green tea beverage
Dietary Supplement: Green tea extract
Dietary Supplement: EGCG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Role of EGCG in Different Application Forms on Flow-mediated Dilation in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: August 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Water
Same volume water as for all intervention arms.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662232

Locations
Germany
Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Mario Lorenz, PhD Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin, Germany
  More Information

No publications provided

Responsible Party: Mario Lorenz, PhD, PhD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01662232     History of Changes
Other Study ID Numbers: Char-EGCG-FMD
Study First Received: August 7, 2012
Last Updated: September 30, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Green tea
EGCG
Cardiovascular diseases
Endothelial function
Flow-mediated dilation

Additional relevant MeSH terms:
Cardiovascular Diseases
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014