薬理と治療

Abstract

Objectives The purpose of this study was to evaluate the safety of long-term intake and excessive intake of the beverage containing heat-killed Lactococcus lactis subsp. lactis JCM 5805（Lc. lactis JCM5805）and resistant maltodextrin. Methods Two randomized, double-blind, placebo-controlled, parallel-group trials were conducted. In the long-term intake trial, forty-four subjects were divided into 2 groups. They took daily one bottle（500 mL）of the beverage containing approximately 100 billion heat-killed Lc. lactis JCM5805 cells and 5 g resistant maltodextrin, or the beverage containing 5 g maltodextrin for 12 weeks. In the excessive intake trial, forty-four subjects were divided into 2 groups. They took daily three bottles（500 mL）of the beverage containing approximately 100 billion heat-killed Lc. lactis JCM5805 cells and 5 g of resistant maltodextrin, or the beverage containing 5g maltodextrin for 4 weeks. Results In the physical, blood, urinary examinations and medical interview, there is no abnormal change caused by the test beverages containing heat-killed Lc. lactis JCM5805 resistant maltodextrin in the long-term and the excessive intake trials. Conclusions These results indicated the intake of the beverage containing heat-killed Lc. lactis JCM5805 and resistant maltodextrin did not have any safety concern for long-term and excessive intake.