Study design
muscle mass, PEW, kidney failure
SECONDARY, KIDNEY FAILURE, OVERHYDRATION
This prospective three-month open-label randomized controlled trial was conducted from August 2022 to November 2022. Sixty-four eligible patients were enrolled and randomly allocated 1:1 to intervention group (IG) and control group (CG). A simple randomization table generated by a computer software program was used to determine randomization. The sequence holder, who was located off-site, determined the allocation. A nutritionist counseled both groups on increasing dietary protein intake (≥ 1.2 g/kg/day) and consuming calorie-dense foods (30–35 kcal/kg/d). In addition, patients in the IG consumed oral nutritional supplement (ONS) powder (NEO-MUNE; Otsuka, Table Patients’ demographics and causes of kidney failure were collected from medical records. Body fluid volume and lean body weight were assessed by bioimpedance analysis using a body composition monitor (Fresenius Medical Care, Germany) after the end of the HD session on the same day as blood sampling. Dry body weight was determined as: post-dialysis weight – overhydration estimated by body composition analysis. Body mass index (BMI) was calculated as: dry body weight (kg) / height (mThe primary outcome of this study was the change in serum albumin level. The secondary outcomes were the changes in (i) other biochemical nutritional and inflammatory markers, including serum prealbumin, cholesterol, total iron binding capacity (TIBC), high-sensitivity C-reactive protein (hs-CRP), and ferritin; (ii) dry weight and BMI as surrogates for body mass; (iii) serum creatinine/BSA and lean body weight as surrogates for muscle mass; (iv) nPNA as a surrogate for dietary protein intake; and (v) the composite French PEW score.
Composition of the oral nutritional supplement (NEO-MUNE; Otsuka) Per 100 g