Volume 10,Issue 1
Fall 2025
Study on the Effects of a Novel Low-Protein Enteral Nutrition Formula on Patients with Chronic Kidney Disease
Objective: To explore the effects of a novel low-protein enteral nutrition formula on the nutritional status of patients with stage 3–4 chronic kidney disease (CKD) under personalized dietary guidance. Methods: Sixty outpatient follow-up patients at West China Hospital, Sichuan University, were randomly divided into an experimental group and a control group. Both groups received personalized dietary guidance and were administered either the novel low-protein enteral nutrition formula or a formula food for special medical purposes (FSMP). Follow-ups were conducted at baseline (day 0), day 45, and day 90 of the intervention. Based on the intention-to-treat analysis principle, generalized estimating equations were used to analyze intergroup differences, time-related trends, and interaction effects of the nutritional formulas. The stability of the results was further verified using a per-protocol analysis. Results: There were no significant intergroup differences in nutritional adequacy, clinical efficacy, or anthropometric indicators (P > 0.05). During the intervention, both groups showed significant reductions in protein (χ² = 17.680, P < 0.001) and sodium (χ² = 21.427, P < 0.001) intake while maintaining stable energy intake. Additionally, total protein (χ² = 18.075, P < 0.001), calcium (χ² = 9.438, P = 0.009), phosphorus (χ² = 13.866, P = 0.001), and uric acid (χ² = 9.005, P = 0.011) levels fluctuated within normal ranges. Per-protocol analysis results were largely consistent with intention-to-treat analysis results, except for significant differences in trends of mid-arm muscle circumference (χ² = 6.435, P = 0.040) and intergroup comparisons of energy ratio (χ² = 4.478, P = 0.034). Conclusion: The novel low-protein enteral nutrition formula is non-inferior to FSMP in improving nutritional status and slowing disease progression in CKD patients. The use of enteral nutrition formulas under dietary guidance supports clinical nutrition management in CKD patients.
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