High-Energy Low-Protein Formula Plus Low-Protein Diet Improves Subjective Global Assessment-Defined Nutritional Status in Nondialysis Chronic Kidney Disease: An Open-Label Randomized Trial

Objective Protein-energy wasting is common in chronic kidney disease (CKD) and maintaining adequate energy intake while counseling patients toward a low-protein diet (LPD) remains challenging. We evaluated whether adding a kidney-specific high-energy, low-protein formula containing free amino acids, dietary fiber, vitamins, and minerals to dietitian-led counseling improved nutritional status in non-dialysis CKD stages 3–5. Methods In this 6-month, single-center, open-label, largely randomized trial analyzed by as-treated principle, all participants received counseling toward protein intake of 0.6–0.8 g/kg ideal body weight (IBW)/day and energy intake of 25–35 kcal/kg IBW/day. The intervention group (n = 48) received 2 daily sachets of the study formula; controls (n = 48) received counseling alone. The primary outcome was improvement in Subjective Global Assessment (SGA) score at 6 months, defined as an increase of at least 1 point. Results The intervention group had a higher proportion of participants with SGA improvement than controls (47.9% vs. 25.0%; P = 0.020; OR, 2.76; 95% CI, 1.16–6.55). Excluding within-category transitions from SGA score 6 to 7 yielded a similar result (44.4% vs. 25.0%; P = 0.049). The intervention effect was greatest in participants with baseline BMI <23 kg/m 2 . Nutritional profiles favored the intervention, and the between-group difference in estimated glomerular filtration rate (eGFR) decline slope was not significant. Conclusion In non-dialysis CKD stages 3–5, adding a kidney-specific high-energy, low-protein formula to counseling toward LPD targets was associated with improved SGA-defined nutritional status without evidence of accelerated eGFR decline over 6 months.