Phase I Clinical Trial With Green Tea Tablets in a Japanese Healthy Population

Publisher Website
Google Scholar
Abstract
Based on our prospective cohort study of healthy volunteers in a town in Saitama prefecture, Japan, we previously reported that drinking green tea prevents cancer. To apply our results to the general population, we conducted a Phase I trial with green tea tablets in 108 Japanese healthy volunteers for 6 months. Each volunteer took 15 green tea tablets per day, a total of 2.25 g of crude green tea extract or 337.5 mg of (-)-epigallocatechin gallate. The dose is equivalent to 10 cups of green tea per day. Effects of green tea tablets on volunteers were examined by various tests on blood samples, such as blood cell counts, serum lipids, hepatologic markers, and body iron; a questionnaire was also used to determine any symptoms experienced. The results of blood examination indicated that none of the volunteers experienced any strong adverse effects. Specifically, 24 volunteers (22%) complained of mild or moderate disorders, such as stomach discomfort or heartburn. Our study provided significant evidence that a Phase I clinical trial with green tea tablets is applicable to healthy Japanese for the purpose of cancer prevention.

This publication has 0 references indexed in Scilit: