Journal of Clinical Toxicology
Open Access

The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: Results of the Minnesota green tea trial

4^th Global Summit on Toxicology

August 24-26, 2015 Philadelphia, USA

Allison M Dostal

Posters-Accepted Abstracts: J Clin Toxicol

Abstract :

Green tea is a popular beverage and is thought to provide health benefits, though adverse reactions to green tea extract (GTE)
have been reported and are not well understood. We conducted a randomized, double-blind, placebo-controlled study of GTE in
which 1075 postmenopausal women with high mammographic density were randomly assigned to consume GTE containing 843 mg
(-)-epigallocatechin-3-gallate (EGCG) or placebo daily for one year. There were no significant differences in % of women with AEs
(75.6% and 72.8% of GTE and placebo groups respectively) or serious AEs (2.2 % and 1.5% of GTE and placebo group respectively).
Women on GTE reported significantly higher incidence of nausea (P<0.001) and dermatologic AEs (P=0.05) and significantly lower
diarrhea incidence (P=0.02). More women in the GTE group experienced an alanine aminotransferase (ALT) elevation compared
with placebo group (n=36 (6.7%) vs. n=4, (0.7%); P<0.001). There were no statistically significant differences between groups in
frequencies of other AEs. Overall, AEs were mainly mild and transient indicating that daily consumption of GTE containing 843 mg
EGCG is generally well tolerated by a group of predominantly Caucasian postmenopausal women. However, 6.7% of GTE consumers
experienced ALT elevations with 1.3% experiencing ALT-related serious AEs.