Study design, ethics and randomisation
This was two-arm parallel, double-blind RCT comparing leucine and placebo supplementation during an eight-week energy restricted dietary program. Random allocation software [The human research ethics committee (HREC) of Curtin University provided ethical approved the study (HREC 4493/2013) and all patients signed a written informed consent. The trial was registered at Australian New Zealand Clinical Trial Registry (Trial Id: ACTRN12615000084583).