Improvement of Endothelial Function by EGCG

Charité University Medicine Berlin

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: EGCG; Dietary Supplement: Green tea beverage; Dietary Supplement: Green tea extract; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01662232

Char-EGCG-FMD

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 4 patient groups, including a placebo group

Green tea beverage

Active Comparator group

Description:

200 mg EGCG as green tea beverage.

Treatment:

Dietary Supplement: Green tea beverage

Green tea extract

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Green tea extract

Epigallocatechin-3-gallate (EGCG)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: EGCG

Placebo (Water)

Placebo Comparator group

Description:

Same volume water as for all intervention arms.

Treatment:

Other: Placebo