Efficacy and Safety of a High-Energy, Low-Protein Formula Replacement Meal for Pre-Dialysis Chronic Kidney Disease Patients: A Randomized Controlled Trial

Abstract

High-energy, low-protein formulas (HE-LPFs) are commonly used as oral nutritional supplements (ONSs) to help provide extra calories to patients who are adhering to a low-protein diet (LPD) after diagnosis with chronic kidney disease (CKD). This randomized controlled trial aimed to evaluate the efficacy and safety of an HE-LPF as either a partial or a total replacement for one meal in pre-dialysis CKD patients. Stage 4-5 CKD patients received either a once-daily HE-LPF (HE-LPF group) or normal food (control group) for a period of 4 weeks while following an LPD. Overall, 73 patients who completed the study were included in the intention-to-treat population. After analyzing the 3-day food records, the HE-LPF group experienced a significant decrease in the percentage of energy derived from protein (p < 0.05) and an increase in the percentage of energy derived from fat (p < 0.05) compared to the control group. The two groups had no significant differences in body weight, body composition, grip strength, renal function, electrolytes, or metabolic markers. The HE-LPF group had a high adherence (94.9% at week 4), and no adverse effects were observed. HE-LPFs are safe to employ as meal replacements for pre-dialysis CKD patients adhering to an LPD.

Keywords: chronic kidney disease; low-protein diet; meal replacement; oral nutritional supplement.

Figure 1

CONSORT flow diagram for trial patients, distinguishing between ITT and PP populations. In the ITT population, 11 patients were discontinued: in the HE-LPF Group, consent withdrawn, n = 2; exclusion criteria, n = 2, one severe liver disease and one albumin < 3. In the Control Group, consent withdrawn, n = 6; exclusion criteria, n = 1, one albumin <3. In the PP population, five patients were discontinued: <85% adherence with the HE-LPF, n = 5 in the HE-LPF Group.

Figure 2

Comparison of 24 h urine protein levels at baseline and after four weeks in the HE-LPF Group and Control Group, (A) ITT population and (B) PP population.