A Randomized Human Study on the Safety and Effectiveness of Powdered Food of Agaricus blazei Murill

Abstract

Safety and effectiveness of powered food made from Agaricus blazei Murill was evaluated by a randomized human study. 45 healthy subjects were divided into 3 groups in sequence: control, 1 pack and 3 packs/day-administered groups. Each group had 15 persons. They had each packs for 28 days, and followed, in every two weeks, by the evaluation with CTCAE v3.0, QOL (SF36-v2), and biochemical examinations including liver/lung/kidney function, insulin resistance and NK activity and high-sensitivity CRP. None of them had adverse events nor biochemical/lung abnormal examinations. 1 and 3 packs-administered groups improved their QOL, high-sensitivity CRP and NK activity in a dose-dependent manner. These results ascertained safety, and effectiveness of the powdered food made from Agaricus blazei Murill against presymptomatic disorders including metabolic syndrome.