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.

Abstract

Objective: Protein-energy wasting is common in chronic kidney disease (CKD) and maintaining adequate energy intake while counseling patients toward a low-protein diet 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 nondialysis CKD stages 3-5.

Methods: In this 6-month, single-center, open-label, largely randomized trial analyzed according to the as-treated principle, all participants received counseling toward protein intake of 0.6-0.8 g/kg ideal body weight/day and energy intake of 25-35 kcal/kg ideal body weight/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 = .020; odds ratio, 2.76; 95% confidence interval, 1.16-6.55). Excluding within-category transitions from SGA score 6 to 7 yielded a similar result (44.4% vs. 25.0%; P = .049). The intervention effect was greatest in participants with baseline body mass index <23 kg/m². Nutritional profiles favored the intervention, and the between-group difference in estimated glomerular filtration rate decline slope was not significant.

Conclusions: In nondialysis CKD stages 3-5, adding a kidney-specific, high-energy low-protein formula to counseling toward low-protein diet targets was associated with improved SGA-defined nutritional status without evidence of accelerated estimated glomerular filtration rate decline over 6 months.