NCT01662232

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1.1 years

First QC Date

August 7, 2012

Last Update Submit

February 2, 2016

Conditions

Cardiovascular Diseases

Keywords

Green teaEGCGCardiovascular diseasesEndothelial functionFlow-mediated dilation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Agonist-induced platelet aggregation in vitro

    2 hours after ingestion

  • Determination of plasma tea polyphenol levels

    2 hours after ingestion

Study Arms (4)

Green tea beverage

ACTIVE COMPARATOR

200 mg EGCG as green tea beverage.

Dietary Supplement: Green tea beverage

Green tea extract

ACTIVE COMPARATOR

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

Dietary Supplement: Green tea extract

Epigallocatechin-3-gallate (EGCG)

ACTIVE COMPARATOR

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

Dietary Supplement: EGCG

Placebo (Water)

PLACEBO COMPARATOR

Same volume water as for all intervention arms.

Other: Placebo

Interventions

Green tea beverageDIETARY_SUPPLEMENT
Green tea beverage
Green tea extractDIETARY_SUPPLEMENT
Green tea extract
EGCGDIETARY_SUPPLEMENT
Epigallocatechin-3-gallate (EGCG)
PlaceboOTHER
Placebo (Water)

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male healthy volunteers
  • years
  • BMI \< 27 kg/m2
  • Cholesterol \< 240 mg/dl

You may not qualify if:

  • Diabetes mellitus
  • Hypertension
  • Conditions with impaired endothelial function
  • Smoking
  • Regular drug use
  • Alcohol abuse
  • Regular tea drinkers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Mario Lorenz, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 10, 2012

Study Start

August 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

DE(1)