Institutional Review Board Statement
The study protocol was reviewed and approved by the Institutional Review Board at the Japan Society of Metabolism and Clinical Nutrition, Tokyo, Japan (approval number: JSMCN 18-001-01) and adhered to the principles of the Declaration of Helsinki. The study was registered in a public trial registry (the UMIN Clinical Trials Registry; clinical trial registration number UMIN000032813 and date of registration 31/05/2018).