2.2. Study Design
nausea
When included in the study, all patients received general education about nutritional support, OS, Mediterranean diet and physical activity; additionally, patients received oral supplementation with calcifediol (in different doses to reach levels of sufficiency, defined with a serum 25OH vitamin D levels > 30 ng/dL) for avoiding confounding results. This was an open clinical trial. Patients were randomly assigned by the clinical investigator to receive either standard hypercaloric, hyperproteic (whey protein-based) OS or hypercaloric, hyperproteic, leucine-enriched oral supplement with a 1:1 allocation during a twelve-week period. Any orexigenic was used. A total of 46 patients were recruited, 23 patients for each arm; during the first week of the study, 2 patients reported nausea with the leucine-enriched oral supplement and switched arms. Nutritional evaluation was performed by the same endocrinologist in all cases; vectorial bioelectrical bioimpedance was performed using a NUTRILAB-Akern impedanciometer (Akern, Florence, Italy); for grip strength, a Jamar