2.1. Study Design
MAY
A multi-center, open-label, two-arm, randomized, comparative clinical trial was performed to evaluate efficacy and safety of increased dietary protein for 6 months for maintaining physical function and ADL in adults aged 75 or older with nutritional risk. The study was approved by the Japan Society of Metabolism and Clinical Nutrition Research Ethics Committee (approval no.: JSMCN 18-001-01) and the Study Protocol was made publicly available on the UMIN Clinical Trials Registry (Clinical trial registration number UMIN000032813 and date of registration 31 May 2018). The study was performed in accordance with the guidelines in the Declaration of Helsinki and was prepared in accordance with CONSORT standards. All participants were given written and oral explanations and informed consent was obtained.