4. Discussion
CKD
RENAL, MALNUTRITION
We evaluated the impact of low-protein renal ONSs as either a complete or a partial meal replacement designed for the dietary management of pre-dialysis CKD patients after four weeks. The main endpoint of efficacy was the change in body weight and other parameters regarding nutritional status, including BMI, body composition, waist circumference, and hand strength; none showed any significant differences between the two groups (ITT and PP populations). In the analysis of 3-day food records, the ITT population showed a significant reduction in the energy percentage obtained from protein. Concurrently, the ITT population showed a significant increase in the energy percentage obtained from fat, including SFAs, MUFAs, and EPA, while the mineral intake remained unchanged. Meanwhile, the PP population experienced a similar result and an increase in energy intake (kcal/kg/day). Recently, a systematic review indicated that a low-protein diet might delay the progression of renal function; however, concomitantly, it may increase the risk of malnutrition, as demonstrated by the reductions seen in BMI and body weight [Safety endpoints did not exhibit any changes in biochemical markers. Renal function was maintained and was not significantly different between the two groups. This result may be explained by considering the impact of weight on serum creatinine levels [Furthermore, implementing an LPD may increase fat and carbohydrate intake, possibly affecting glycemic control or lipid profile metabolic markers. The results of metabolic markers remained stable, presumably due to either the favorable fatty acid profile or the replacement of the protein-rich foods using an HE-LPF as an interventional ONS. In our study, the analysis of the 3 day food records showed that the intake of MUFAs and EPA increased, as did that of SFAs. Evidence suggests that a MUFA-rich diet is beneficial in regulating fat oxidation, weight maintenance, and cholesterol metabolism [Adherence to the investigational product was perfect, with only a slight reduction in the last two weeks of the study compared to the first 2 week period. This result is also promising for applications in clinical practice. Uremic symptoms in CKD patients, particularly those not dialyzed, elicit taste changes and reduced food appeal [There were several limitations to this study. First, the current study may have been too short in its relative duration and could not improve nutritional status. Previous studies have reported that body weight and BMI using renal-specific ONSs for six months were enhanced in patients with advanced CKD [