Evaluation of the Safety and Efficacy of Kaempferia parviflora Extract�iSIRTMAX®�jin Human
�|A Randomized Double-blind, Placebo-controlled Crossover Clinical Study�|

Objective�@Kaempferia parviflora is a plant belonging to the family Zingiberaceae. Its rhizome has been used in strength precision drugs and tonics and has been reported to exhibit prevention effect on metabolic diseases in mice. In this study, we examined the safety and efficacy of Kaempferia parviflora extract�iSIRTMAX®�jon obesity, glucose and lipid metabolism, and arterial stiffness in human.
Methods�@We performed a randomized double-blind, placebo-controlled crossover clinical study. Twentycseven healthy volunteers were given either a test product containing 100 mg of SIRTMAX® or a placebo by oral administration for 7 weeks.
Results�@Body weight and fasting blood glucose declined significantly�iP��0.0033, and P��0.04�jin the SIRTMAX® group. For the subjects whose HbA1c values�iNGSP�jwere more than 5.4�“, improvement trends in the fasting blood glucose�i127.9�}17.8 mg/dL before and 120.7�}14.9 mg/dL after ingestion�jand the cardio-ankle vascular index�iCAVI, 8.0�}0.2 before and 7.8�}0.2 after ingestion�jwere observed in the SIRTMAX® group. Furthermore, only a slight increase in the production of advanced glycation end products�iAGEs�jwas observed in the SIRTMAX® group�i26.0�}3.4ƒÊg/mL before and 27.4�}1.8ƒÊg/mL after ingestion, P��0.64�j, compared with a significant increase in the placebo group�i22.4�}2.6ƒÊg/mL before and 29.1�}2.1ƒÊg/mL after ingestion, P��0.02�j. No abnormal values were observed during the test.
Conclusion�@SIRTMAX® had the ameliorative effects on body weight and blood glucose level for all 27 subjects, and improved the vascular function for the subjects with mild hyperglycemia�iHbA1c�†5.4�“�j. No severe adverse effects caused by SIRTMAX® were found during the test.