Abstract
Background: Muscle wasting, observed in patients with end-stage kidney disease and protein energy wasting (PEW), is associated with increased mortality for those on hemodialysis (HD). Oral nutritional supplementation (ONS) and nutrition counseling (NC) are treatment options for PEW but research targeting muscle status, as an outcome metric, is limited.Aim: We compared the effects of combined treatment (ONS + NC) vs. NC alone on muscle status and nutritional parameters in HD patients with PEW.Methods: This multi-center randomized, open label-controlled trial, registered under ClinicalTrials.gov (Identifier no. NCT04789031), recruited 56 HD patients identified with PEW using the International Society of Renal Nutrition and Metabolism criteria. Patients were randomly allocated to intervention (ONS + NC, n = 29) and control (NC, n = 27) groups. The ONS + NC received commercial renal-specific ONS providing 475 kcal and 21.7 g of protein daily for 6 months. Both groups also received standard NC during the study period. Differences in quadriceps muscle status assessed using ultrasound (US) imaging, arm muscle area and circumference, bio-impedance spectroscopy (BIS), and handgrip strength (HGS) methods were analyzed using the generalized linear model for repeated measures.Results: Muscle indices as per US metrics indicated significance (p < 0.001) for group × time interaction only in the ONS + NC group, with increases by 8.3 and 7.7% for quadriceps muscle thickness and 4.5% for cross-sectional area (all p < 0.05). This effect was not observed for arm muscle area and circumference, BIS metrics and HGS in both the groups. ONS + NC compared to NC demonstrated increased dry weight (p = 0.039), mid-thigh girth (p = 0.004), serum prealbumin (p = 0.005), normalized protein catabolic rate (p = 0.025), and dietary intakes (p < 0.001), along with lower malnutrition–inflammation score (MIS) (p = 0.041). At the end of the study, lesser patients in the ONS + NC group were diagnosed with PEW (24.1%, p = 0.008) as they had achieved dietary adequacy with ONS provision.Conclusion: Combination of ONS with NC was effective in treating PEW and contributed to a gain in the muscle status as assessed by the US, suggesting that the treatment for PEW requires nutritional optimization via ONS.
Highlights
Treating underlying muscle wasting in malnourished patients with chronic kidney disease (CKD) is challenging
The protein energy wasting (PEW) was identified when any 3 out of 4 International Society of Renal Nutrtition and Metabolism (ISRNM) diagnostic criteria were met: BMI 10% in mid-arm muscle circumference (MAMC) related to the 50th percentile of the reference population, serum albumin
Out of 101 eligible HD patients identified with PEW, only 80 patients consented to participate in this study
Summary
Treating underlying muscle wasting in malnourished patients with chronic kidney disease (CKD) is challenging. The onset of muscle wasting establishes at the early stages of CKD, and the commencement of the dialysis treatment at end-stage kidney disease is an iatrogenic factor for malnutrition as it promotes muscle proteolysis [1]. The issue of muscle wasting is associated with protein energy wasting (PEW) in patients who undergo dialysis, a syndrome affecting 28–54% of patients worldwide [2]. In patients who undergo dialysis, low muscle mass is associated with frailty, depression, malnutrition [3], and poor quality of life [4,5,6]; and is a strong predictor of hospitalization and mortality [7, 8]. Muscle wasting, observed in patients with end-stage kidney disease and protein energy wasting (PEW), is associated with increased mortality for those on hemodialysis (HD). Oral nutritional supplementation (ONS) and nutrition counseling (NC) are treatment options for PEW but research targeting muscle status, as an outcome metric, is limited
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