薬理と治療

Abstract

Objectives We carried out two double−blind, placebo−controlled, parallel group studies toinvestigate the safety of long−term intake and excessive intake of the black tea polyphenols（BTP）−enriched black tea beverage.Methods The subjects for the safety evaluation of long−term intake were 40 healthy volunteers（the test drink group：20 adults, the placebo group：20 adults）. They consumed 1 bottleof the test drink or the placebo per meal（3 bottles per day）for 12 weeks. The subjects forthe safety evaluation of excessive intake were 30 healthy volunteers（the test drink group：15 adults, the placebo group：15 adults）. They consumed 3 bottles of the test drink or theplacebo at a meal per day for 4 weeks.Results Any abnormal changes in clinical findings such as laboratory blood test, urinalysisand physical examination were not induced by the test drink.Conclusion These results suggested that the BTP−enriched black tea beverage is safewhen it is consumed 3 bottles per day for 12 weeks or 3 bottles at a meal everyday for 4weeks.（Jpn Pharmacol Ther 2009；37：773−89）KEY WORDS Black tea polyphenols−enriched black tea, Long−term intake, Excessiveintake, Safety evaluation