2.2. Study Design
This was a randomized, open, controlled, clinical trial. Patients were randomly assigned by the clinical investigator to receive either a Mediterranean diet alone or a Mediterranean diet plus two hypercaloric, hyperproteic OSs per day with a 1:1 allocation for twenty-four weeks. Specifically, the OS was composed with a mixture of slow-release carbohydrates and fiber; the specific composition of the OS is presented in Nutritional evaluation was performed by the same endocrinologist in all cases. Physical examination included body composition analysis (bioelectrical bioimpedance, and abdominal, arm and calf circumferences), functional tests (up-and-go test and handgrip strength) and nutritional ultrasound of abdominal adipose tissue and rectus femoris (RF) muscle of the quadriceps. Specifically, vectorial bioelectrical bioimpedance (BIA) was performed using a NUTRILAB-Akern impedanciometer (Akern, Pis, Italy); for handgrip strength, a Jamar