The objective of this Phase VII study was to assess the potential for green
tea to be used as a colorectal cancer chemopreventive agent. This study me
asured the dose-related biological effects of administration of a single do
se of green tea on the rectal mucosa of normal volunteers, Volunteers were
admitted to the Robert Wood Johnson Medical School Clinical Research Center
for 24 h. Baseline blood and rectal biopsy samples were obtained before th
e volunteers drank 0.6, 1.2, or 1.8 g of green tea solids dissolved in warm
water. Blood samples were taken 2, 4, 8, and 24 h after the tea administra
tion. Rectal biopsies were obtained at 4, 8, and 24 h. Prostaglandin E-2 (P
GE(2)) levels were analyzed by ELISA. Tea polyphenol levels in the blood, u
rine, and rectal tissue were measured by high-performance liquid chromatogr
aphy using a Coulochem electrode array detection system. Statistical compar
isons were made using ANOVA. Decreased levels of PGE(2) in rectal mucosa we
re observed at 4 and 8 h after consumption of green tea. There was no corre
lation between inhibition of PGE(2) and tissue or plasma levels of tea poly
phenols. Ten of 14 subjects demonstrated a response to green tea, as eviden
ced by at least a 50% inhibition of PGE(2) levels at 4 h, We conclude that
green tea constituents have biological activity in inhibiting PGE(2) synthe
sis. Given the 71% "response rate," we believe these data support the study
of green tea as a colorectal chemopreventive agent in more long-term Phase
II trials.