乳酸菌Lactococcus lactis subsp. lactis JCM 5805および難消化性デキストリン含有飲料の長期摂取時および過剰摂取時における安全性の検討―プラセボ対照ランダム化二重盲検並行群間比較試験―

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.