{"paper_id":"4c403469-5124-436c-8a47-66e3450ee561","body_text":"Simply Adding Oral Nutritional Supplementation to Haemodialysis Patients May Not Be Enough: Real-life Prospective Interventional Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Simply Adding Oral Nutritional Supplementation to Haemodialysis Patients May Not Be Enough: Real-life Prospective Interventional Study Andreja Ocepek, Robert Ekart, Petra Povalej Bržan, Sebastjan Bevc This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-2728029/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction: Protein energy wasting (PEW) is a common and serious co-morbidity in haemodialysis patients. Its importance as a prognostic factor has been increasingly recognised during past decades. Much effort has been invested in the improvement of nutritional status and amelioration of consequences through different therapeutic approaches, either intradialytic parenteral nutrition or more commonly oral nutritional supplementation. In the article, we present the results of a prospective study in haemodialysis patients after 12 months of therapeutic intervention with ONS. Methods: 92 HD adult patients were enrolled in the study after three months wash-out period. At baseline nutritional status was assessed using composite scores, laboratory markers, bioelectrical impedance analysis and hand-grip strength test. Patients recognised as undernourished or at high risk for undernutrition received renal-specific commercially available ONS on haemodialysis day in addition to their regular diet. After 12 months, the effect of ONS on surrogate markers of undernutrition, serum albumin level, phase angle and hand-grip strength was analysed in 71 surviving patients. Results: After 12 months data for 71 patients, 39 (54.9%) male, 62.4±12.9 years, median haemodialysis vintage 53.3 (IQR 65.3) months, was available. Patients were divided into three groups: in group A were patients with normal nutritional status at baseline not necessitating ONS; in group B were patients who received ONS; and in group C were patients entitled to receive but refused to take ONS. Baseline results showed statistically significant differences between groups in serum albumin levels and phase angle but not hand-grip strength. Differences between groups remained statistically significant at month 12; we did not find any statistically significant positive changes within groups indicating no positive effect of intervention with ONS. Conclusions: In a prospectively designed interventional single-centre study, we did not find a statistically significant change of surrogate markers of PEW in our cohort of haemodialysis patients receiving ONS for 12 months. Since PEW is an independent risk factor influencing the survival of haemodialysis patients, efforts should be directed towards a timely and comprehensive nutritional approach, including intensive, personalised dietary counselling, increase in protein and energy intake and advocating tight control of nutritional status during haemodialysis treatment, possibly providing psychological support and motivation. haemodialysis protein-energy wasting oral nutritional supplementation serum albumin phase angle hand-grip strength test Figures Figure 1 Figure 2 BACKGROUND Protein-energy wasting (PEW) is highly prevalent in patients with chronic kidney failure especially in patients undergoing maintenance haemodialysis (HD) ( 1 ). PEW is a complex syndrome influenced by multiple factors. Insufficient dietary energy and protein intake, chronic inflammation and catabolic effects of HD procedure are just some of many underlying issues that impact the nutritional status (NUS) of HD patients. Standard PEW criteria developed in 2008 by the International Society of Renal Nutrition and Metabolism (ISRNM) are time-consuming and difficult to implement in daily clinical practice; therefore, simplified classifications or surrogate markers of malnutrition may be more applicable in day-to-day work ( 2 , 3 ). Although nonspecific and influenced by many different factors, low serum albumin remains an important indicator of malnutrition and a simple yet strong predictor of mortality risk in HD patients ( 4 , 5 ). Other biochemical parameters, e.g. serum lipids, total iron binding capacity (TIBC) and C-reactive protein (CRP), are readily used as malnutrition-inflammation markers, while serum potassium and phosphorus levels are monitored safety parameters in HD patients ( 4 , 5 ). Among anthropometric measurements, body mass index (BMI), mid-upper arm muscle circumference (MUAMC) calculated from mid-arm circumference (MAC) and triceps skinfold thickness (TSFT) are regularly utilised, as are hand grip strength (HGS) test for assessment of muscle function and bioelectrical impedance analysis (BIA) derived phase angle (PhA) as an indicator of body cell mass and integrity ( 5 , 6 ). Nutritional intervention studies in HD patients have indicated that the addition of protein and energy-rich supplements to a regular diet may exert a positive effect on several nutritional parameters, subjective global assessment (SGA) of NUS, performance status, quality of life, and prognosis, including hospital re-admission rates and all-cause mortality ( 7 – 9 ). On the other hand, a meta-analysis elucidated only low-quality evidence in support of short-term (up to 6 months) oral energy or protein/amino acid supplements in improving NUS ( 4 ). Consequently, the authors concluded that further studies were necessary, particularly regarding the effects of oral nutritional supplementation (ONS) on mortality and quality of life ( 4 ). The aim of our study was to assess the effect of long-term (12 months) ONS on surrogate markers of PEW in a real-life, single-centre cohort, prospective interventional study in HD patients. METHODS Study design This was a prospective, longitudinal interventional study with repeated measure design on a well-defined cohort of HD patients at the Department of Dialysis, University Medical Centre Maribor, Slovenia. Study population We assessed 140 consecutive patients for study eligibility. All patients on HD were considered. Patients younger than 18 and undergoing dialysis for less than six months were excluded. Thirty-eight patients refused to participate. Finally, 92 patients were included in the study. Figure 1 demonstrates the patient selection process. Measurements and variables We collected data on the medical history along with prescribed medications, HD vintage, atherosclerosis risk factors and comorbidities (arterial hypertension, diabetes mellitus, dyslipidemia, ischemic heart disease, peripheral arterial disease, cerebral arterial disease, cancer). To perform laboratory tests, blood was drawn from a peripheral vein prior to and after HD. Patients were categorized into three groups after baseline NUS was assessed (group 1: patients with normal NUS, group 2: patients with high risk for undernutrition; group 3: undernourished patients) using composite tools including SGA, malnutrition-inflammation score (MIS), anthropometric and biochemical parameters. Laboratory parameters regularly used to describe malnutrition in HD patients, e.g. serum albumin, total cholesterol, triglycerides, TIBC, inflammation marker CRP, and safety markers potassium and phosphate, were recorded. Anthropometric measurements were made, e.g. body weight after the HD procedure and body height were measured with a standard medical scale, waist circumference (WC) and MAC were measured in cm using a tape measure, TSFT was measured in mm using Jamar® skinfold calliper (Lafayette Instrument, Lafayette, IN, USA), BMI and MUAMC were calculated using standard formulas (BMI (kg/m 2 ) = body weight (kg)/body height (m) 2 and MUAMC (cm) = MAC (cm) − 0.314 x TSFT (mm)). Additionally, body composition using BIA and HGS test were done at inclusion, during follow-up and after 12 months. BIA was performed after regular HD sessions with the Bodystat® Quadscan 4000 device (Bodystat Ltd., Isle of Man) with the patient resting in a supine position with pairs of electrodes placed on the dorsum of the hand and foot on the side of the body opposite to the arteriovenous (AV) fistula. The software provided by the manufacturer calculated PhA, fat-free mass index (FFMI) and dry lean mass (DLM). After the same HD session HGS in kg on the arm without AV fistula was measured with the patient in a sitting position, their elbow at 90°, and their forearm in a neutral position using Jamar® handgrip hydraulic dynamometer (Lafayette Instrument, Lafayette, IN, USA). The calculated average HGS of three consecutive measurements was used for analysis. Intervention After a three months wash-out period for all subjects, undernourished patients (group 3) and patients with a high risk for undernutrition (group 2) were prescribed ONS for 12 months. In addition to their regular diet, patients received two bottles of commercially available disease-specific sip-drink (Nepro HP®, Abbott Nutrition) after every HD procedure. All patients were equally followed according to their HD schedule, and the duration of the intervention was 12 months. Outcome The primary outcome was defined as the change in surrogate markers of NUS, e.g. serum albumin, PhA and HGS, from baseline to month 12. Secondary outcomes included changes in another laboratory (TIBC, total cholesterol, triglycerides, CRP), anthropometric (BMI, WC, MAC, MUAMC) and BIA (FFMI, DLM) measurements and two safety parameters, serum potassium and phosphate concentrations. Statistical analysis All statistical calculations were conducted using the R programming language (10). Numerical variables are summarized as a mean value ± standard deviation (MV±SD) or a median and interquartile range (M (IQR)). Categorical variables are presented as a frequency (percentage). An ANOVA or nonparametric Kruskal Wallis test was used to compare the numerical variables among groups. In case of statistically significant differences among groups, we performed Tukey or Dunn non-parametric posthoc test for paired comparisons. For categorical variables, Fisher’s exact test was used. Changes in observed parameters at baseline and after 12 months within groups were compared using paired samples t-test or non-parametric Wilcoxon signed-rank test depending on data distribution. In case of statistically significant differences we performed post-hoc Tukey or Dunn non-parametric test for paired comparisons. A p-value < 0.05 was considered statistically significant. RESULTS Data for 71 patients, 39 (54.9%) male, 62.4±12.9 years, median HD vintage 53.3 (IQR 65.3) months, were available for analysis after 12 months. The most prevalent co-morbidities were arterial hypertension, diabetes mellitus and cardiovascular diseases, contributing to the second leading cause of death in our cohort, in accordance with other authors confirming atherosclerosis as one of the most significant causes of morbidity and mortality in the developed world (11). Three patients were lost to follow-up (2 patients received a kidney transplant, and one patient moved to another HD centre), and 18 patients died, eight due to an infectious cause (4 of pneumonia, 4 of sepsis), six due to cardiovascular complications, three due to malignant disease (lymphoma, kidney carcinoma and lung carcinoma) and one due to hypoglycaemia. After 12 months, three groups were formed for statistical analysis according to ONS intake (figure 1): in group A (n=25) were patients with normal NUS at baseline, in group B (n=37) were patients who received ONS, and in group C (n=9) were patients prescribed ONS but refused to take them. Patients who received less than half prescribed ONS for less than three months were classified in group C. In group B, patients received, on average 1531.49 kcal and 61.38 g of protein per week in addition to their regular diet. The baseline characteristics of patients are summarized in table 1. At baseline, groups were similar in demographics and co-morbidities. The mean age of all patients was 62.4±12.9 years and was not significantly different among groups. Patients in group B were on maintenance HD the longest, however, the difference among groups was not significant (p=0.868). Patients in group B had a significantly higher prevalence of malignant disease than the other two groups (p=0.043). All other characteristics, e.g. gender, other co-morbidities and dietary intake of calories and protein, were not significantly different between groups (table 1). Changes in surrogate markers of NUS at baseline and after 12 months within each group and between groups are depicted in table 2 and figure 2. Baseline results showed significantly higher values in serum albumin levels (p Tukey <0.001) and PhA (p Tukey <0.001) when comparing group A with group B and group A with group C (serum albumin p Tukey <0.001 and PhA p Tukey =0.008). There were no statistically significant differences in HGS. Serum albumin and PhA stayed significantly different between groups but showed no statistically significant improvement during follow-up after 12 months within groups, including group B receiving ONS. We observed a statistically significant worsening of serum albumin levels in group A (p=0.015) and a worsening of PhA in group B (p=0.028) despite intervention with ONS in this group. There was no statistically significant change in HGS between and within groups during follow-up. Changes in other measured parameters at baseline and after 12 months within each group and between groups are shown in table 3. Values of BMI (p=0.022 for both comparisons), MAC (p=0.03 and p=0.037), FFMI (p=0.004 and p=0.001) and DLM (p=0.011 and p=0.004) were significantly higher in group A when comparing it with group B and group C. MUAMC was significantly higher in group A compared with group C (p=0.01), but there was no statistically significant difference between groups A and B. There were no statistically significant differences in values of WC, TIBC, total cholesterol, triglycerides and CRP between groups at baseline. There were no statistically significant differences between groups B and C in any measured parameter at baseline. After 12 months, we observed a slight significantly positive change in FFMI (p=0.039) but negative changes of MAC (p=0.003), MUAMC (p=0.001) and DLM (p=0.016) within group A and negative changes of MAC (p=0.01), MUAMC (p<0.001) and DLM (p<0.001) within group B during follow-up. We believe this indicates progressive muscle mass loss in HD patients, even ones supplemented with ONS. In group C, there was no statistically significant change in any observed parameters, probably due to the small number of patients. We observed the worst outcome in group C since 16 out of 25 included patients died during 12 month-follow-up (figure 1). In groups A and B, one patient died in each group during 12 months, both due to cardiac arrest. Although the prevalence of cancer was significantly higher in group B, no patients died due to cancer in this group. Regarding the safety of ONS, we observed no statistically significant change in potassium and phosphate at month 12 in group B. Table 1: Baseline characteristics Group A (n=25) MV±SD M (IQR) Group B (n=37) MV±SD M (IQR) Group C (n=9) MV±SD M (IQR) p-value Demographics Age (years) 58.0±13.2 59.0 (17.0) 65.8±11.3 65.0 (11.0) 60.3±15.8 64.0 (14.0) 0.055 Gender (male; n (%)) 17 (68%) 19 (51.4%) 3 (33.3%) 0.172 Dialysis vintage (months) 71.2±65.3 45.4 (70.5) 73.1±63.7 61.9 (55.4) 64±36.8 45.7 (51.6) 0.868 Co-morbidities Diabetes mellitus 9 (36%) 12 (32%) 3 (33%) 0.939 Arterial hypertension 21 (84%) 32 (86%) 8 (89%) 1.000 Cardio-vascular diseases 5 (23.81%) 12 (57.14%) 4 (19.05%) 0.332 Cancer 1 (4%) 10 (27%) 1 (11%) 0.043 Dietary parameters Dietary energy intake (kcal/day) 1483.8±515.5 1424.3 (501.6) 1547.8±477.4 1563.7 (629.2) 1379.4±461.7 1411.2 (373.3) 0.729 Dietary protein intake (g/day) 63.0±30.7 54.4 (24.9) 59.2±18.8 57.7 (21.9) 57.0±26.4 56.8 (15.9) 0.964 MV±SD = mean value ± standard deviation; M = median; IQR = interquartile range; Cardiovascular diseases = ischemic heart disease, peripheral arterial disease and cerebral arterial disease. P values <0.05 were considered statistically significant and are marked bold. Table 2: Changes in surrogate markers of NUS at baseline and after 12 months Group A (n=25) MV±SD M (IQR) p-value (baseline-12 mo) Group B (n=37) MV±SD M (IQR) p-value (baseline-12 mo) Group C (n=9) MV±SD M (IQR) p-value (baseline-12 mo) p-value (between groups) Albumin (mg/L) baseline 42.1±1.6 42.1 (2.5) 0.015 38.1±2.6 38.2 (3.1) 0.137 38.5±2.5 38.8 (1.2) 0.286 <0.001 12 mo 39.6±4.3 40.0 (3.9) 37.2±3.3 38.4 (4.2) 38.0±2.4 36.3 (3.9) 0.014 PhA (◦) baseline 5.5±1.1 5.2 (1.2) 0.258 4.4±0.8 4.4 (1.2) 0.028 4.3±1-3 4.4 (1.4) 0.498 <0.001 12 mo 5.5±2.1 5.2 (1.5) 4.2±1.0 4.1 (1.5) 4.2±1.1 4.5 (1.6) 0.001 HGS (kg) baseline 24.8±10.2 25.7 (14.0) 0.115 22.1±8.7 22.3 (13.0) 0.656 19.3±7.8 15.0 (12.7) 0.362 0.275 12 mo 26.8±11.8 23.7 (19.0) 21.4±8.7 21.3 (11.3) 20.1±9.6 15.0 (14.7) 0.119 12 mo = after 12 months; MV±SD = mean value ± standard deviation; M = median; IQR = interquartile range; PhA = phase angle; HGS = hand grip strength. P-values <0.05 were considered statistically significant and are marked bold. Table 3: Changes in other measured parameters at baseline and after 12 months Group A (n=25) MV±SD M (IQR) p-value (baseline-12 mo) Group B (n=37) MV±SD M (IQR) p-value (baseline-12 mo) Group C (n=9) MV±SD M (IQR) p-value (baseline-12 mo) p-value (between groups) BMI (kg/m2) baseline 28.4±5.0 27.0 (5.0) 0.360 25.5±6.0 24.2 (6.9) 0.097 23.3±5.3 21.9 (3.2) 0.652 0.009 12 mo 28.0±5.2 27.3 (5.6) 25.1±5.9 24.0 (7.6) 23.3±4.7 21.9 (5.0) 0.019 WC (cm) baseline 103.6±13.5 103.4 (11) 0.600 96.2±18.0 93.0 (24.3) 0.789 91.1±19.0 89.0 (8.0) 0.594 0.049 12 mo 102.5±17.3 98.4 (15) 95.9±18.3 92.5 (22.5) 90.5±17.6 90 (9.0) 0.112 MAC (cm) baseline 30.5±3.8 31.0 (5.0) 0.003 28.3±5.0 27.0 (6.0) 0.010 26.3±4.6 26.0 (4.7) 0.076 0.015 12 mo 29.0±3.2 29.8 (3.9) 27.5±5.4 26.5 (5.1) 24.2±3.4 24.5 (5.9) 0.006 MUAMC (cm) baseline 26.2±2.5 26.1 (3.5) 0.001 24.4±3.6 24.2 (5.6) <0.001 22.5±2.7 22.0 (4.2) 0.008 0.008 12 mo 24.4±3.1 24.6 (5.2) 22.8±3.6 22.7 (4.1) 20.3±2.6 19.8 (4.4) 0.007 FFMI baseline 18.5±2.7 18.4 (4.3) 0.039 16.2±2.9 15.8 (4.2) 0.925 14.6±2.1 15.5 (3.6) 0.906 <0.001 12 mo 19.1±2.8 18.5 (3.9) 16.2±2.9 16.2 (4.0) 14.7±2.3 15.6 (3.1) <0.001 DLM (kg) baseline 13.3±5.2 12.7 (7.9) 0.016 9.5±4.7 9.0 (6.9) <0.001 6.9±4.7 5.9 (4.0) 0.326 0.002 12 mo 12.8±5.2 12.5 (8.7) 8.9±4.8 8.7 (6.9) 7.7±4.2 6.8 (4.7) 0.005 TIBC baseline 47.1±6.5 47.7 (10.0) 0.330 44.7±9.7 42.7 (10.1) 0.193 42.4±6.5 42.7 (5.0) 0.250 0.049 12 mo 46.0±9.5 42.7 (14.5) 43.5±10.6 41.9 (8.1) 39.5±10.5 35.9 (5.8) 0.081 Total cholesterol (mmol/L) baseline 4.5±1.4 4.2 (1.5) 0.679 4.0±1.0 3.9 (1.3) 0.827 4.1±1.3 3.6 (1.7) 1.000 0.463 12 mo 4.3±0.8 4.2 (1.2) 4.0±1.0 4.2 (1.4) 4.3±1.1 4.0 (1.8) 0.488 TG (mmol/L) baseline 2.0±1.3 1.7 (1.4) 0.594 1.5±0.8 1.4 (0.9) 0.700 1.9±2.3 1.2 (0.7) 0.800 0.128 12 mo 1.9±1.1 1.8 (1.2) 1.4±0.6 1.4 (0.5) 1.6±0.9 1.4 (0.7) 0.273 CRP (mg/L) baseline 7.3±14.6 1.0 (6.0) 0.224 7.8±10.0 4.0 (7.0) 0.122 6.6±6.0 5.0 (5.0) 0.151 0.557 12 mo 10.4±18.1 6.0 (8.0) 12.4±15.2 6.0 (14.0) 24.4±36.5 13.0 (21.0) 0.580 Potassium (mmol/L) baseline 4.8±0.5 4.7 (0.6) 0.696 4.7±0.5 4.7 (0.4) 0.700 4.7±0.5 4.8 (0.6) 0.042 0.934 12 mo 4.7±0.7 4.7 (0.6) 4.8±0.7 4.9 (0.7) 4.9±0.5 5.0 (0.5) 0.517 Phosphate (mmol/L) baseline 1.7±0.4 1.6 (0.5) 0.737 1.5±0.4 1.4 (0.5) 0.446 1.5±0.4 1.6 (0.4) 0.820 0.058 12 mo 1.7±0.5 1.7 (0.6) 1.5±0.5 1.4 (0.4) 1.6±0.5 1.7 (0.5) 0.092 12 mo = after 12 months; MV±SD = mean value ± standard deviation; M = median; IQR = interquartile range; BMI = body mass index; WC = waist circumference; MAC = mid-arm circumference; MUAMC = mid-upper arm muscle circumference; FFMI = fat free mass index; DLM = dry lean mass; TIBC = total iron binding capacity; TG = triglycerides; CRP = C-reactive protein. P-values <0.05 were considered statistically significant and are marked bold. DISCUSSION In our real-life single-centre cohort study, we prospectively evaluated the effect of ONS on surrogate markers of NUS in HD patients. We did not find any statistically significant improvement after 12 months of intervention, although our preliminary results of short-term intervention suggested a possible positive effect of ONS on the preservation of NUS in HD patients (12). Data from two systematic reviews and a meta-analysis of randomised control trials showed mixed results regarding the effects of ONS on certain markers of NUS in HD patients, e.g. albumin, pre-albumin, MUAMC, TSFT, BMI, lean mass (4,13). Although albumin is not solely a marker of NUS and is influenced by many factors in HD patients (e.g. inflammation, overhydration, protein catabolism during HD session), it is still widely used as a traditional biochemical marker of NUS (14,15). Albumin has also persistently been correlated with morbidity and mortality in HD patients (8,16,17). In our study, serum albumin at baseline was significantly lower in groups B and C compared to group A, but there was no difference between groups B and C. During follow-up, we observed continuous statistically significant differences in serum albumin between groups but no change in serum albumin within group B, although patients were receiving ONS. There was a significant worsening of serum albumin in group A, where patients were evaluated as having normal NUS at baseline, indicating likely an important deterioration of overall health and NUS in these patients during a 12-monthperiod. PhA is derived from bioelectrical impedance analysis of body composition and reflects body cell mass and integrity. PhA has been shown to be altered in patients with chronic kidney disease of different stages (18). In HD patients, PhA correlates with certain nutritional markers, e.g. albumin, pre-albumin, fat-free mass, and MUAMC, and it has been shown to be a strong independent predictor of PEW (6,19). In our cohort of HD patients, we observed statistically significant differences in PhA between groups at baseline, consistent with their NUS. However, PhA has worsened at month 12 in group B, despite receiving ONS, again pointing to an important deterioration of body cell mass and integrity in this well-defined population of patients. Muscle function can, in clinical practice, be easily assessed using the HGS test. It is a simple, readily repeatable, reliable, non-invasive tool which has been shown to have a negative correlation with frequently used nutritional screening tools (e.g. SGA, MIS, BMI) and a positive correlation with other nutritional markers (e.g. PhA, fat-free mass and MAC) (20–22). HGS was also confirmed to be an independent predictor of all-cause mortality with a cut-off value of 22,5 kg for men and 7 kg for women independent of dialysis modality (21). Our study did not demonstrate a significant difference in HGS between groups at baseline. Furthermore, we observed no statistically significant change in HGS during follow-up in any of the groups. Our results are do not align with published literature showing a positive effect of ONS on markers of NUS (1). On the other hand, a recent review in the Cochrane library and a meta-analysis of randomised controlled trials debate that there is still a lack of evidence concerning the effect of ONS on NUS in HD patients (4,13). We believe the intake of calories and protein with ONS in our group of patients was not sufficient. Recommended intake is 7-10 kcal of energy and 0.3-0.4 g of protein per kg of body weight per day, which target patients in our cohort could not reach (1,23). Another important issue may be the time of administration of ONS. In our study, patients received ONS after HD sessions, not intradialyticaly which would expectedly counteract the catabolic effect of HD (23,24). The reason for such an approach was the patient’s convenience and desire to avoid potential side effects, mostly intradialytic hypotension and gastrointestinal symptoms, thus lowering adherence to ONS. A critical assessment of our results proved this approach to be questionable since adherence was still insufficient, which is, in our belief, the leading cause for the negative result of the study. Up to 50% of HD patients consume less than 1.0 g of protein/kg/ day with their regular diet and have insufficient dietary energy intake as well (3). In our cohort mean dietary energy intake was 1504.2±484.9 kcal per day, and the median protein intake was 56.8 (IQR 23.3) g per day, and groups did not differ in dietary intake of energy or protein, presenting clearly that most patients in our cohort did not have a sufficient intake of nutrients with their regular diet. HD patients are inclined to continue following dietary restrictions recommended during the pre-dialysis period of chronic kidney failure. Nutritional counselling is therefore recommended as a first intervention (24,25). Such a basic intervention may be lacking in HD centres due to staff shortages, as in our centre. As a further consequence, one of the pivotal limitations of our study was volatile adherence to ONS. In HD patients’ low adherence to ONS is, in our opinion, a result of taste fatigue, lack of regular dietary consultations and an inclination towards reluctance and even depression in this group of patients. Systematic nutritional support with regular consultations with a clinical dietitian is expected to improve the NUS of HD patients receiving ONS (26). Furthermore, a systematic review of depression in HD patients reported high dietary non-adherence, ranging from 41.1 to as high as 98.3%, with a significant association between depressive symptoms and dietary non-adherence. The authors recommended early diagnosis and treatment of depression and close monitoring of adherence behaviour to enhance adherence and improve the quality of life and survival rates of HD patients (27). Finally, complementary and alternative medicine is also popular in the HD population, corresponding with dietary non-adherence (28,29). Acknowledging and addressing depression, complementary and alternative medicine may significantly influence dietary adherence in our cohort of HD patients, therefore, in the future additional efforts should be directed towards psychological evaluation and support. CONCLUSIONS In our cohort of HD patients, simply adding ONS to a regular diet did not improve surrogate markers of PEW. Further efforts must be directed into a timely and comprehensive nutritional approach, including systematic, personalized dietary counselling to increase protein and energy intake, advocating tight control of NUS during HD treatment and possibly providing psychological support and motivation. Abbreviations AV; arterio-venous BIA; bioelectrical impedance analysis BMI; body mass index CRP; C-reactive protein DLM; dry lean mass FFMI; fat-free mass index HD; haemodialysis HGS; hand grip strength IQR; interquartile range ISRNM; International Society of Renal Nutrition and Metabolism M; median MAC; mid-arm circumference MIS: malnutrition-inflammation score MUAMC; mid-upper arm muscle circumference MV; mean value NUS; nutritional status ONS; oral nutritional supplementation PEW; protein-energy wasting PhA; phase angle SD; standard deviation SGA; subjective global assessment TIBC; total iron binding capacity TG; triglycerides TSFT; triceps skinfold thickness WC; waist circumference Declarations Acknowledgements Not applicable. Author Contribution AO, PP and SB wrote the manuscript. AO was a major contributor in writing the manuscript. PP performed the statistical analysis. AO, PP and SB analysed and interpreted the statistical results. AO and PP created tables and figures. All authors reviewed and approved the final manuscript. Funding This publication did not receive any external funding. Data Availability Datasets used in this article are available from corresponding author on reasonable request. Ethics approval and consent to participate The study was approved by the National Ethics Committee of Slovenia and adhered to Helsinki Declaration (study registration number: 0120-664/2015-2) approved 11/01/2016. Informed consent was obtained from each patient at inclusion. All methods were performed in accordance with the relevant guidelines and regulations. Consent for publication Not applicable. Conflict of interest The authors have no conflicts of interest to declare. References Ikizler TA, Cano NJ, Franch H, Fouque D, Himmelfarb J, Kalantar-Zadeh K et al. Prevention and treatment of protein energy wasting in chronic kidney disease patients: A consensus statement by the International Society of Renal Nutrition and Metabolism. Kidney Int [Internet]. 2013;84(6):1096–107. Available from: http://dx.doi.org/10.1038/ki.2013.147 Fouque D, Kopple J, Cano N, Chauveau P, Cuppari L, Franch H et al. A proposed nomenclature and diagnostic criteria for protein – energy wasting in acute and chronic kidney disease. Kidney Int [Internet]. 2008;73(4):391–8. Available from: http://dx.doi.org/10.1038/sj.ki.5002585 Gracia-Iguacel C, González-Parra E, Mahillo I, Ortiz A. Criteria for classi fi cation of protein – energy wasting in dialysis patients: impact on prevalence. Br J Nutr. 2019;121:1271–8. Liu PJ, Ma F, Wang QY, He SL. The effects of oral nutritional supplements in patients with maintenance dialysis therapy: A systematic review and meta-analysis of randomized clinical trials. PLoS ONE. 2018;13(9):1–17. Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, et al. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020;2020:5. Tan R, Ms DL, Liu Y, Zhong X, Bs DZ, Ms JM. Bioelectrical Impedance Analysis – Derived Phase Angle Predicts Protein – Energy Wasting in Maintenance Hemodialysis. J Ren Nutr [Internet]. 2019;29(4):295–301. Available from: https://doi.org/10.1053/j.jrn.2018.09.001 Riobó Serván P, Ortiz Arduan A. Eficacia de la suplementación oral intradiálisis en pacientes con insuficiencia renal crónica. Endocrinol y Nutr. 2011;58(5):236–42. Weiner DE, Tighiouart H, Ladik V, Meyer KB, Zager PG, Johnson DS. Oral Intradialytic Nutritional Supplement Use and Mortality in Hemodialysis Patients. Am J Kidney Dis [Internet]. 2014;63(2):276–85. Available from: http://dx.doi.org/10.1053/j.ajkd.2013.08.007 Amanda K, Leonberg-Yoo W, Wang, Daniel E, Weiner ELJ. Oral Nutritional Supplements and 30-Day Readmission Rate in Hypoalbuminemic Maintenance Hemodialysis Patients. Hemodial Int. 2019;23(1):93–100. R Core Team. R: A Language and Environment for Statistical Computing. [Internet]. R Foundation for Statistical Computing, Vienna. ; 2021. Available from: https://www.r-project.org Piko N, Ekart R, Bevc S, Hojs R. Atherosclerosis, epigenetic modifications, and arterial stiffness. ACTA MEDICO–BIOTECHNICA. 2017;10(2):10–7. Ocepek A, Bevc S, Ekart R. Impact of short-term nutritional supplementation on surrogate markers of undernutrition in hemodialysis patients – prospective real-life interventional study. Clin Nephrol. 2017;00(Suppl1):1–4. Jy M, Sw C, Am D, Sm G, Lp M. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020;5(5):CD012616. Gama-Axelsson T, Heimbu O, Stenvinkel P, Barany P, Lindholm B, Qureshi AR. Serum Albumin as Predictor of Nutritional Status in Patients with ESRD. CJASN ePress. 2012;7(6):1–8. Friedman AN, Fadem SZ. Reassessment of Albumin as a Nutritional Marker in Kidney Disease. J Am Soc Nephrol. 2010;21:223–30. Kato A, Takita T, Furuhashi M, Maruyama Y, Hishida A. Comparison of serum albumin, C-reactive protein and carotid atherosclerosis as predictors of 10-year mortality in hemodialysis patients. Hemodial Int. 2010;14(2):226–32. Kalantar-Zadeh K, Kopple JD, Humphreys MH, Block G. Comparing outcome predictability of markers of malnutrition – inflammation complex syndrome in haemodialysis patients. Nephrol Dial Transpl. 2004;19(6):1507–19. Bellizzi V, Scalfi L, Terracciano V, De Nicola L, Minutolo R, Marra M, et al. Early changes in bioelectrical estimates of body composition in chronic kidney disease. J Am Soc Nephrol. 2006;17(5):1481–7. Zhou H, Yao W, Pan D, Sun G. Predicational ability of phase angle on protein energy wasting in kidney disease patients with renal replacement therapy: A cross- ­ sectional study.Food Sci Nutr. 2021;(April):3573–9. Garcia Ferreira M, Wazlawik E, Moreno YMF, Fuhr ML, González-Chica DA. Diagnostic accuracy of handgrip strength in the assessment of malnutrition in hemodialyzed patients. ESPEN J [Internet]. 2013;8(4):e181–6. Available from: http://dx.doi.org/10.1016/j.clnme.2013.06.003 Vogt BP, Clementoni M, Borges C, Regina C, Go D, Costa J, et al. Handgrip strength is an independent predictor of all-cause mortality in maintenance dialysis patients. Clin Nutr ESPEN. 2016;35(6):1429–33. Bakkal H, Dizdar OS, Erdem S, Kulakoğlu S, Akcakaya B, Katırcılar Y, et al. The Relationship Between Hand Grip Strength and Nutritional Status Determined by Malnutrition Inflammation Score and Biochemical Parameters in Hemodialysis Patients. J Ren Nutr. 2020;30(6):548–55. Sabatino A, Regolisti G, Karupaiah T, Shathevan S, Sadu Singh B, Khor B et al. Protein-energy wasting and nutritional supplementation in patients with end-stage renal disease on hemodialysis. Clin Nutr [Internet]. 2017;36(3):663–71. Available from: http://dx.doi.org/10.1016/j.clnu.2016.06.007 Sabatino A, Piotti G, Cosola C, Gandolfini I, Kooman JP, Fiaccadori E. Dietary protein and nutritional supplements in conventional hemodialysis. Semin Dial. 2018;31(6):583–91. Jo I-Y, Kim WJ, Park HC, Choi HY, Lee JE, Lee SM. Effect of Personalized Nutritional Counseling on the Nutritional Status of Hemodialysis Patients. Clin Nutr Res. 2017;6(4):285. Limwannata P, Satirapoj B, Chotsriluecha S, Thimachai P, Supasyndh O. Effectiveness of renal-specific oral nutritional supplements compared with diet counseling in malnourished hemodialysis patients. Int Urol Nephrol [Internet]. 2021;53(8):1675–87. Available from: https://doi.org/10.1007/s11255-020-02768-5 Gebrie MH, Ford J. Depressive symptoms and dietary non-adherence among end stage renal disease patients undergoing hemodialysis therapy: Systematic review. BMC Nephrol. 2019;20(1):1–7. Duncan HJ, Pittman S, Govil A, Sorn L, Bissler G, Schultz T, et al. Alternative medicine use in dialysis patients: potential for good and bad! Nephron - Clinical Practice. 2007;105(3):108–13. Ivetic CB, Klemenc-Ketis Z, Kersnik J. Use of complementary and alternative treatment methods among adults in Slovenia. ACTA MEDICO–BIOTECHNICA. 2013;6(1):51–8. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {\"props\":{\"pageProps\":{\"initialData\":{\"identity\":\"rs-2728029\",\"acceptedTermsAndConditions\":true,\"allowDirectSubmit\":true,\"archivedVersions\":[],\"articleType\":\"Research Article\",\"associatedPublications\":[],\"authors\":[{\"id\":199179624,\"identity\":\"f896a86d-f427-416f-83cc-14d6d85c9bfe\",\"order_by\":0,\"name\":\"Andreja Ocepek\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"University Medical Centre Maribor\",\"correspondingAuthor\":false,\"submittingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Andreja\",\"middleName\":\"\",\"lastName\":\"Ocepek\",\"suffix\":\"\"},{\"id\":199179625,\"identity\":\"2f5166ea-9182-4f71-bd37-6690a3c25b83\",\"order_by\":1,\"name\":\"Robert Ekart\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"University Medical Centre Maribor\",\"correspondingAuthor\":false,\"submittingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Robert\",\"middleName\":\"\",\"lastName\":\"Ekart\",\"suffix\":\"\"},{\"id\":199179626,\"identity\":\"18a341ea-4f9b-4d17-a3e0-684e137c5589\",\"order_by\":2,\"name\":\"Petra Povalej Bržan\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"University of Maribor\",\"correspondingAuthor\":false,\"submittingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Petra\",\"middleName\":\"Povalej\",\"lastName\":\"Bržan\",\"suffix\":\"\"},{\"id\":199179627,\"identity\":\"015b7114-0903-4604-9b88-93e9c7857d18\",\"order_by\":3,\"name\":\"Sebastjan Bevc\",\"email\":\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABAklEQVRIiWNgGAWjYFACHhDBBmPYMEgASWYYF7eWBLiWNKK1wK07DNeCE8i39x78+PMHn7w5A+/Bxzw15xNnth9g3VzAUCeDS4vBmXPJ0jwJbIY7G/iSjXmO3U6cDeTdnsFwGKfDDCRyDKSBfmHccIDHTHJmw+3EeRL8327zMBzAqUV+/hvjnz8S2OyBWsx/zmw4B9TCwAbUUofb+zd4zCSATkkE2cLwseFA4myIFmbcDjuTl2bNk8aWvOEwX7LEh2PJxjN7QH4xwO0X+fazh2/+sDlmu+F478EPCTV2sjOOH2C7XVBRZ4/TYRBwDD0uDAhoYGCoIahiFIyCUTAKRjAAABdEUUTuMvuPAAAAAElFTkSuQmCC\",\"orcid\":\"\",\"institution\":\"University of Maribor\",\"correspondingAuthor\":true,\"submittingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Sebastjan\",\"middleName\":\"\",\"lastName\":\"Bevc\",\"suffix\":\"\"}],\"badges\":[],\"createdAt\":\"2023-03-23 14:14:23\",\"currentVersionCode\":1,\"declarations\":\"\",\"doi\":\"10.21203/rs.3.rs-2728029/v1\",\"doiUrl\":\"https://doi.org/10.21203/rs.3.rs-2728029/v1\",\"draftVersion\":[],\"editorialEvents\":[],\"editorialNote\":\"\",\"failedWorkflow\":false,\"files\":[{\"id\":37101452,\"identity\":\"9cf1a439-3e06-4816-89e1-300c31326376\",\"added_by\":\"auto\",\"created_at\":\"2023-05-16 17:23:02\",\"extension\":\"png\",\"order_by\":1,\"title\":\"Figure 1\",\"display\":\"\",\"copyAsset\":false,\"role\":\"figure\",\"size\":52702,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003eFlow of clinical study\\u003c/p\\u003e\\n\\u003cp\\u003eNUS = nutritional status, ONS = oral nutritional supplements, HD = haemodialysis\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"floatimage1.png\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-2728029/v1/27b821f4ec2b06f15c36e698.png\"},{\"id\":37101451,\"identity\":\"7c0f9b2f-6fd7-4072-a272-e0baf38c6f27\",\"added_by\":\"auto\",\"created_at\":\"2023-05-16 17:23:02\",\"extension\":\"png\",\"order_by\":2,\"title\":\"Figure 2\",\"display\":\"\",\"copyAsset\":false,\"role\":\"figure\",\"size\":122104,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003eChanges of surrogate markers of PEW\\u003c/p\\u003e\\n\\u003cp\\u003ePhA = phase angle, HGS = hand-grip strength\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"floatimage2.png\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-2728029/v1/b478965c8fc5ce8e8eee9e40.png\"},{\"id\":39052747,\"identity\":\"335c7db9-10dd-4c51-875e-208b50f11542\",\"added_by\":\"auto\",\"created_at\":\"2023-06-26 04:59:43\",\"extension\":\"pdf\",\"order_by\":0,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"manuscript-pdf\",\"size\":424746,\"visible\":true,\"origin\":\"\",\"legend\":\"\",\"description\":\"\",\"filename\":\"manuscript.pdf\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-2728029/v1/09195ae6-bb4c-4d2b-964a-5c907763fcb2.pdf\"}],\"financialInterests\":\"No competing interests reported.\",\"formattedTitle\":\"\\u003cp\\u003eSimply Adding Oral Nutritional Supplementation to Haemodialysis Patients May Not Be Enough: Real-life Prospective Interventional Study\\u003c/p\\u003e\",\"fulltext\":[{\"header\":\"BACKGROUND\",\"content\":\"\\u003cp\\u003eProtein-energy wasting (PEW) is highly prevalent in patients with chronic kidney failure especially in patients undergoing maintenance haemodialysis (HD) (\\u003cspan citationid=\\\"CR1\\\" class=\\\"CitationRef\\\"\\u003e1\\u003c/span\\u003e). PEW is a complex syndrome influenced by multiple factors. Insufficient dietary energy and protein intake, chronic inflammation and catabolic effects of HD procedure are just some of many underlying issues that impact the nutritional status (NUS) of HD patients. Standard PEW criteria developed in 2008 by the International Society of Renal Nutrition and Metabolism (ISRNM) are time-consuming and difficult to implement in daily clinical practice; therefore, simplified classifications or surrogate markers of malnutrition may be more applicable in day-to-day work (\\u003cspan citationid=\\\"CR2\\\" class=\\\"CitationRef\\\"\\u003e2\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR3\\\" class=\\\"CitationRef\\\"\\u003e3\\u003c/span\\u003e). Although nonspecific and influenced by many different factors, low serum albumin remains an important indicator of malnutrition and a simple yet strong predictor of mortality risk in HD patients (\\u003cspan citationid=\\\"CR4\\\" class=\\\"CitationRef\\\"\\u003e4\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR5\\\" class=\\\"CitationRef\\\"\\u003e5\\u003c/span\\u003e). Other biochemical parameters, e.g. serum lipids, total iron binding capacity (TIBC) and C-reactive protein (CRP), are readily used as malnutrition-inflammation markers, while serum potassium and phosphorus levels are monitored safety parameters in HD patients (\\u003cspan citationid=\\\"CR4\\\" class=\\\"CitationRef\\\"\\u003e4\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR5\\\" class=\\\"CitationRef\\\"\\u003e5\\u003c/span\\u003e). Among anthropometric measurements, body mass index (BMI), mid-upper arm muscle circumference (MUAMC) calculated from mid-arm circumference (MAC) and triceps skinfold thickness (TSFT) are regularly utilised, as are hand grip strength (HGS) test for assessment of muscle function and bioelectrical impedance analysis (BIA) derived phase angle (PhA) as an indicator of body cell mass and integrity (\\u003cspan citationid=\\\"CR5\\\" class=\\\"CitationRef\\\"\\u003e5\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR6\\\" class=\\\"CitationRef\\\"\\u003e6\\u003c/span\\u003e). Nutritional intervention studies in HD patients have indicated that the addition of protein and energy-rich supplements to a regular diet may exert a positive effect on several nutritional parameters, subjective global assessment (SGA) of NUS, performance status, quality of life, and prognosis, including hospital re-admission rates and all-cause mortality (\\u003cspan additionalcitationids=\\\"CR8\\\" citationid=\\\"CR7\\\" class=\\\"CitationRef\\\"\\u003e7\\u003c/span\\u003e\\u0026ndash;\\u003cspan citationid=\\\"CR9\\\" class=\\\"CitationRef\\\"\\u003e9\\u003c/span\\u003e). On the other hand, a meta-analysis elucidated only low-quality evidence in support of short-term (up to 6 months) oral energy or protein/amino acid supplements in improving NUS (\\u003cspan citationid=\\\"CR4\\\" class=\\\"CitationRef\\\"\\u003e4\\u003c/span\\u003e). Consequently, the authors concluded that further studies were necessary, particularly regarding the effects of oral nutritional supplementation (ONS) on mortality and quality of life (\\u003cspan citationid=\\\"CR4\\\" class=\\\"CitationRef\\\"\\u003e4\\u003c/span\\u003e).\\u003c/p\\u003e \\u003cp\\u003eThe aim of our study was to assess the effect of long-term (12 months) ONS on surrogate markers of PEW in a real-life, single-centre cohort, prospective interventional study in HD patients.\\u003c/p\\u003e\"},{\"header\":\"METHODS\",\"content\":\"\\u003cp\\u003eStudy design\\u003c/p\\u003e\\n\\u003cp\\u003eThis was a prospective, longitudinal interventional study with repeated measure design on a well-defined cohort of HD patients at the Department\\u0026nbsp;of Dialysis, University Medical Centre Maribor, Slovenia.\\u003c/p\\u003e\\n\\u003cp\\u003eStudy population\\u003c/p\\u003e\\n\\u003cp\\u003eWe assessed 140 consecutive patients\\u0026nbsp;for study eligibility. All patients on HD were considered. Patients younger than 18 and undergoing dialysis for less than six months were excluded. Thirty-eight patients refused to participate. Finally, 92 patients were included in the study.\\u0026nbsp;\\u0026nbsp;Figure 1 demonstrates the patient selection process.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003eMeasurements and variables\\u003c/p\\u003e\\n\\u003cp\\u003eWe collected data on the medical history along with prescribed medications, HD vintage, atherosclerosis risk factors and comorbidities (arterial hypertension, diabetes mellitus, dyslipidemia, ischemic heart disease, peripheral arterial disease, cerebral arterial disease, cancer). To perform laboratory tests, blood was drawn from a peripheral vein prior to and after HD. Patients\\u0026nbsp;were categorized into three groups after baseline NUS was assessed (group 1: patients with normal NUS, group 2: patients with high risk for undernutrition; group 3: undernourished patients) using composite tools including SGA, malnutrition-inflammation score (MIS), anthropometric and biochemical parameters. Laboratory parameters regularly used to describe malnutrition in HD patients, e.g. serum albumin, total cholesterol, triglycerides, TIBC, inflammation marker CRP, and safety markers potassium and phosphate, \\u0026nbsp;were recorded. Anthropometric measurements were made, e.g. body weight after the HD procedure and body height were measured with a standard medical scale, waist circumference (WC) and MAC\\u0026nbsp;were measured in cm using a tape measure,\\u0026nbsp;TSFT was measured in mm using Jamar\\u0026reg;\\u0026nbsp;skinfold calliper (Lafayette Instrument, Lafayette, IN, USA), BMI and MUAMC were calculated using standard formulas (BMI (kg/m\\u003csup\\u003e2\\u003c/sup\\u003e) = body weight (kg)/body height (m)\\u003csup\\u003e2\\u003c/sup\\u003e and\\u0026nbsp;MUAMC (cm) = MAC (cm) \\u0026minus; 0.314 x TSFT (mm)). Additionally, body composition using BIA and HGS test were done at inclusion, during follow-up and after 12 months. BIA was performed after regular HD sessions with the Bodystat\\u0026reg; Quadscan 4000 device (Bodystat Ltd., Isle of Man) with the patient resting in a supine position with pairs of electrodes placed on the dorsum of the hand and foot on the side of the body opposite to the arteriovenous (AV) fistula. The software provided by the manufacturer calculated PhA, fat-free mass index (FFMI) and dry lean mass (DLM). After the same HD session HGS in kg on the arm without AV fistula was measured with the patient in a sitting position, their elbow at 90\\u0026deg;, and their forearm in a neutral position using Jamar\\u0026reg; handgrip hydraulic dynamometer (Lafayette Instrument, Lafayette, IN, USA). The calculated average HGS of three consecutive measurements was used for analysis.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003eIntervention\\u003c/p\\u003e\\n\\u003cp\\u003eAfter a three months wash-out period for all subjects, undernourished patients (group 3) and patients with a high risk for undernutrition (group 2) were prescribed ONS for 12 months. In addition to their regular diet, patients received two bottles of commercially available disease-specific sip-drink (Nepro HP\\u0026reg;, Abbott Nutrition) after every HD procedure. All patients were equally followed according to their HD schedule, and the duration of the intervention was 12 months.\\u003c/p\\u003e\\n\\u003cp\\u003eOutcome\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003eThe primary outcome was defined as the change in surrogate markers of NUS, e.g. serum albumin, PhA and HGS, from baseline to month 12. Secondary outcomes included changes in another laboratory (TIBC, total cholesterol, triglycerides, CRP), anthropometric (BMI, WC, MAC, MUAMC) and BIA (FFMI, DLM) measurements and two safety parameters, serum potassium and phosphate concentrations.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003eStatistical analysis\\u003c/p\\u003e\\n\\u003cp\\u003eAll statistical calculations were conducted using the R programming language (10). Numerical variables are summarized as a mean value \\u0026plusmn; standard deviation (MV\\u0026plusmn;SD) or a median and interquartile range (M (IQR)). Categorical variables are presented as a frequency (percentage). An ANOVA or nonparametric Kruskal Wallis test was used to compare the numerical variables among groups. In case of statistically significant differences among groups, we performed Tukey or Dunn non-parametric posthoc test for paired comparisons. \\u0026nbsp;For categorical variables, Fisher\\u0026rsquo;s exact test was used. Changes in observed parameters at baseline and after 12 months within groups were compared using paired samples t-test or non-parametric Wilcoxon signed-rank test depending on data distribution. In case of statistically significant differences we performed post-hoc Tukey or Dunn non-parametric test for paired comparisons. A p-value \\u0026lt; 0.05 was considered statistically significant.\\u003c/p\\u003e\"},{\"header\":\"RESULTS\",\"content\":\"\\u003cp\\u003eData for 71 patients, 39 (54.9%) male, 62.4\\u0026plusmn;12.9 years, median HD vintage 53.3 (IQR 65.3) months, were available for analysis after 12 months. The most prevalent co-morbidities were arterial hypertension, diabetes mellitus and cardiovascular diseases, contributing to the second leading cause of death in our cohort, in accordance with other authors confirming atherosclerosis as one of the most significant causes of morbidity and mortality in the developed world (11). Three patients were lost to follow-up (2 patients received a kidney transplant, and one patient moved to another HD centre), and 18 patients died, eight due to an infectious cause (4 of pneumonia, 4 of sepsis), six due to cardiovascular complications, three due to malignant disease (lymphoma, kidney carcinoma and lung carcinoma) and one due to hypoglycaemia. After 12 months, three groups were formed for statistical analysis according to ONS intake (figure 1): in group A (n=25) were patients with normal NUS at baseline, in group B (n=37) were patients who received ONS, and in group C (n=9) were patients prescribed ONS but refused to take them. Patients who received less than half prescribed ONS for less than three months were classified in group C. In group B, patients received, on average 1531.49 kcal and 61.38 g of protein per week in addition to their regular diet. The baseline characteristics of patients are summarized in table 1.\\u003c/p\\u003e\\n\\u003cp\\u003eAt baseline, groups were similar in demographics and co-morbidities. The mean age of all patients was 62.4\\u0026plusmn;12.9 years and was not significantly different among groups. Patients in group B were on maintenance HD the longest, however, the difference among groups was not significant (p=0.868). Patients in group B had a significantly higher prevalence of malignant disease than the other two groups (p=0.043). All other characteristics, e.g. gender, other co-morbidities and dietary intake of calories and protein, were not significantly different between groups (table 1).\\u003c/p\\u003e\\n\\u003cp\\u003eChanges in surrogate markers of NUS at baseline and after 12 months within each group and between groups are depicted in table 2 and figure 2. Baseline results showed significantly higher values in serum albumin levels (p\\u003csub\\u003eTukey\\u003c/sub\\u003e\\u0026lt;0.001) and PhA \\u0026nbsp;(p\\u003csub\\u003eTukey\\u003c/sub\\u003e\\u0026lt;0.001) when comparing group A with group B and group A with group C (serum albumin p\\u003csub\\u003eTukey\\u003c/sub\\u003e\\u0026lt;0.001 and PhA p\\u003csub\\u003eTukey\\u003c/sub\\u003e=0.008). There were no statistically significant differences in HGS. Serum albumin and PhA stayed significantly different between groups but showed no statistically significant improvement during follow-up after 12 months within groups, including group B receiving ONS. We observed a statistically significant worsening of serum albumin levels in group A (p=0.015)\\u0026nbsp;and a worsening of PhA in group B (p=0.028) despite intervention with ONS in this group. There was no statistically significant change in HGS between and within groups during follow-up.\\u003c/p\\u003e\\n\\u003cp\\u003eChanges in other measured parameters at baseline and after 12 months within each group and between groups are shown in table 3. Values of BMI (p=0.022 for both comparisons), MAC (p=0.03 and p=0.037), FFMI (p=0.004 and p=0.001) and DLM (p=0.011 and p=0.004) were significantly higher in group A when comparing it with group B and group C. MUAMC was significantly higher in group A compared with group C (p=0.01), but there was no statistically significant difference between groups A and B. There were no statistically significant differences in values of WC, TIBC, total cholesterol, triglycerides and CRP between groups at baseline. There were no statistically significant differences between groups B and C in any measured parameter at baseline.\\u003c/p\\u003e\\n\\u003cp\\u003eAfter 12 months, we observed a slight significantly positive change in FFMI (p=0.039) but negative changes of MAC (p=0.003), MUAMC (p=0.001) and DLM (p=0.016) within group A and negative changes of MAC (p=0.01), MUAMC (p\\u0026lt;0.001) and DLM (p\\u0026lt;0.001) within group B during follow-up. We believe this indicates progressive muscle mass loss in HD patients, even ones supplemented with ONS. In group C, there was no statistically significant change in any observed parameters, probably due to the small number of patients. We observed the worst outcome in group C since 16 out of 25 included patients died during 12 month-follow-up (figure 1). In groups A and B, one patient died in each group during 12 months, both due to cardiac arrest. Although the prevalence of cancer was significantly higher in group B, no patients died due to cancer in this group.\\u003c/p\\u003e\\n\\u003cp\\u003eRegarding the safety of ONS, we observed no statistically significant change in potassium and phosphate at month 12 in group B.\\u003c/p\\u003e\\n\\u003cp\\u003eTable 1: Baseline characteristics\\u003c/p\\u003e\\n\\u003ctable border=\\\"1\\\" cellspacing=\\\"0\\\" cellpadding=\\\"0\\\" width=\\\"624\\\"\\u003e\\n \\u003ctbody\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"36.43659711075441%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003eGroup A\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003cp\\u003e(n=25)\\u003c/p\\u003e\\n \\u003cp\\u003eMV\\u0026plusmn;SD\\u003c/p\\u003e\\n \\u003cp\\u003eM (IQR)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003eGroup B\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003cp\\u003e(n=37)\\u003c/p\\u003e\\n \\u003cp\\u003eMV\\u0026plusmn;SD\\u003c/p\\u003e\\n \\u003cp\\u003eM (IQR)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"15.088282504012842%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003eGroup C\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003cp\\u003e(n=9)\\u003c/p\\u003e\\n \\u003cp\\u003eMV\\u0026plusmn;SD\\u003c/p\\u003e\\n \\u003cp\\u003eM (IQR)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.199036918138042%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ep-value\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"36.43659711075441%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e\\u003cem\\u003eDemographics\\u0026nbsp;\\u003c/em\\u003e\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"15.088282504012842%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.199036918138042%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"36.43659711075441%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp; \\u0026nbsp; \\u0026nbsp;Age (years)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e58.0\\u0026plusmn;13.2\\u003c/p\\u003e\\n \\u003cp\\u003e59.0 (17.0)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e65.8\\u0026plusmn;11.3\\u003c/p\\u003e\\n \\u003cp\\u003e65.0 (11.0)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"15.088282504012842%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e60.3\\u0026plusmn;15.8\\u003c/p\\u003e\\n \\u003cp\\u003e64.0 (14.0)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.199036918138042%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.055\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"36.43659711075441%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp; \\u0026nbsp; \\u0026nbsp;Gender (male; n (%))\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e17 (68%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e19 (51.4%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"15.088282504012842%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e3 (33.3%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.199036918138042%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.172\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"36.43659711075441%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003eDialysis vintage (months)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e71.2\\u0026plusmn;65.3\\u003c/p\\u003e\\n \\u003cp\\u003e45.4 (70.5)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e73.1\\u0026plusmn;63.7\\u003c/p\\u003e\\n \\u003cp\\u003e61.9 (55.4)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"15.088282504012842%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e64\\u0026plusmn;36.8\\u003c/p\\u003e\\n \\u003cp\\u003e45.7 (51.6)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.199036918138042%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.868\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"36.43659711075441%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e\\u003cem\\u003eCo-morbidities\\u003c/em\\u003e\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"15.088282504012842%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.199036918138042%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"36.43659711075441%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp; \\u0026nbsp; \\u0026nbsp;Diabetes mellitus\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e9 (36%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e12 (32%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"15.088282504012842%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e3 (33%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.199036918138042%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.939\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"36.43659711075441%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp; \\u0026nbsp; \\u0026nbsp;Arterial hypertension\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e21 (84%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e32 (86%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"15.088282504012842%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e8 (89%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.199036918138042%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1.000\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"36.43659711075441%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp; \\u0026nbsp; \\u0026nbsp;Cardio-vascular diseases\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e5 (23.81%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e12 (57.14%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"15.088282504012842%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e4 (19.05%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.199036918138042%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.332\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"36.43659711075441%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp; \\u0026nbsp; \\u0026nbsp;Cancer\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1 (4%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e10 (27%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"15.088282504012842%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1 (11%)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.199036918138042%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e0.043\\u003c/strong\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"36.43659711075441%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e\\u003cem\\u003eDietary parameters\\u003c/em\\u003e\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"15.088282504012842%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.199036918138042%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"36.43659711075441%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp; \\u0026nbsp; \\u0026nbsp;Dietary energy intake (kcal/day)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1483.8\\u0026plusmn;515.5\\u003c/p\\u003e\\n \\u003cp\\u003e1424.3 (501.6)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1547.8\\u0026plusmn;477.4\\u003c/p\\u003e\\n \\u003cp\\u003e1563.7 (629.2)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"15.088282504012842%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1379.4\\u0026plusmn;461.7\\u003c/p\\u003e\\n \\u003cp\\u003e1411.2 (373.3)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.199036918138042%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.729\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"36.43659711075441%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp; \\u0026nbsp; \\u0026nbsp;Dietary protein intake (g/day)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e63.0\\u0026plusmn;30.7\\u003c/p\\u003e\\n \\u003cp\\u003e54.4 (24.9)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.13804173354735%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e59.2\\u0026plusmn;18.8\\u003c/p\\u003e\\n \\u003cp\\u003e57.7 (21.9)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"15.088282504012842%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e57.0\\u0026plusmn;26.4\\u003c/p\\u003e\\n \\u003cp\\u003e56.8 (15.9)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.199036918138042%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.964\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003c/tbody\\u003e\\n\\u003c/table\\u003e\\n\\u003cp\\u003eMV\\u0026plusmn;SD = mean value \\u0026plusmn; standard deviation; M = median; IQR = interquartile range; Cardiovascular diseases = ischemic heart disease, peripheral arterial disease and cerebral arterial disease. P values \\u0026lt;0.05 were considered statistically significant and are marked bold.\\u003c/p\\u003e\\n\\u003cp\\u003eTable 2: Changes in surrogate markers of NUS at baseline and after 12 months\\u003c/p\\u003e\\n\\u003ctable border=\\\"1\\\" cellspacing=\\\"0\\\" cellpadding=\\\"0\\\" width=\\\"623\\\"\\u003e\\n \\u003ctbody\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"12.01923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"9.134615384615385%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003eGroup A\\u0026nbsp;\\u003c/strong\\u003e(n=25)\\u003c/p\\u003e\\n \\u003cp\\u003eMV\\u0026plusmn;SD\\u003c/p\\u003e\\n \\u003cp\\u003eM (IQR)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ep-value\\u003c/p\\u003e\\n \\u003cp\\u003e(baseline-12 mo)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003eGroup B\\u0026nbsp;\\u003c/strong\\u003e(n=37)\\u003c/p\\u003e\\n \\u003cp\\u003eMV\\u0026plusmn;SD\\u003c/p\\u003e\\n \\u003cp\\u003eM (IQR)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ep-value\\u003c/p\\u003e\\n \\u003cp\\u003e(baseline-12 mo)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003eGroup C\\u0026nbsp;\\u003c/strong\\u003e(n=9)\\u003c/p\\u003e\\n \\u003cp\\u003eMV\\u0026plusmn;SD\\u003c/p\\u003e\\n \\u003cp\\u003eM (IQR)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ep-value\\u003c/p\\u003e\\n \\u003cp\\u003e(baseline-12 mo)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ep-value\\u003c/p\\u003e\\n \\u003cp\\u003e(between groups)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"12.01923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003eAlbumin\\u0026nbsp;(mg/L)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"9.134615384615385%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ebaseline\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e42.1\\u0026plusmn;1.6\\u003c/p\\u003e\\n \\u003cp\\u003e42.1 (2.5)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e0.015\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e38.1\\u0026plusmn;2.6\\u003c/p\\u003e\\n \\u003cp\\u003e38.2 (3.1)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.137\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e38.5\\u0026plusmn;2.5\\u003c/p\\u003e\\n \\u003cp\\u003e38.8 (1.2)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.286\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e\\u0026lt;0.001\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"16.23931623931624%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e12 mo\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e39.6\\u0026plusmn;4.3\\u003c/p\\u003e\\n \\u003cp\\u003e40.0 (3.9)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e37.2\\u0026plusmn;3.3\\u003c/p\\u003e\\n \\u003cp\\u003e38.4 (4.2)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e38.0\\u0026plusmn;2.4\\u003c/p\\u003e\\n \\u003cp\\u003e36.3 (3.9)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.803418803418804%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e0.014\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"12.01923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ePhA\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e(◦)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"9.134615384615385%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ebaseline\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e5.5\\u0026plusmn;1.1\\u003c/p\\u003e\\n \\u003cp\\u003e5.2 (1.2)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.258\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e4.4\\u0026plusmn;0.8\\u003c/p\\u003e\\n \\u003cp\\u003e4.4 (1.2)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e0.028\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e4.3\\u0026plusmn;1-3\\u003c/p\\u003e\\n \\u003cp\\u003e4.4 (1.4)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.498\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e\\u0026lt;0.001\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"16.23931623931624%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e12 mo\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e5.5\\u0026plusmn;2.1\\u003c/p\\u003e\\n \\u003cp\\u003e5.2 (1.5)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e4.2\\u0026plusmn;1.0\\u003c/p\\u003e\\n \\u003cp\\u003e4.1 (1.5)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e4.2\\u0026plusmn;1.1\\u003c/p\\u003e\\n \\u003cp\\u003e4.5 (1.6)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.803418803418804%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e0.001\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"12.01923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003eHGS\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e(kg)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"9.134615384615385%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ebaseline\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e24.8\\u0026plusmn;10.2\\u003c/p\\u003e\\n \\u003cp\\u003e25.7 (14.0)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.115\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e22.1\\u0026plusmn;8.7\\u003c/p\\u003e\\n \\u003cp\\u003e22.3 (13.0)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.656\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e19.3\\u0026plusmn;7.8\\u003c/p\\u003e\\n \\u003cp\\u003e15.0 (12.7)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.362\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.275\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"16.23931623931624%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e12 mo\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e26.8\\u0026plusmn;11.8\\u003c/p\\u003e\\n \\u003cp\\u003e23.7 (19.0)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e21.4\\u0026plusmn;8.7\\u003c/p\\u003e\\n \\u003cp\\u003e21.3 (11.3)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e20.1\\u0026plusmn;9.6\\u003c/p\\u003e\\n \\u003cp\\u003e15.0 (14.7)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.803418803418804%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.119\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003c/tbody\\u003e\\n\\u003c/table\\u003e\\n\\u003cp\\u003e12 mo\\u0026nbsp;= after 12 months; MV\\u0026plusmn;SD = mean value \\u0026plusmn; standard deviation; M = median; IQR = interquartile range; PhA = phase angle; HGS = hand grip strength. P-values \\u0026lt;0.05 were considered statistically significant and are marked bold.\\u003c/p\\u003e\\n\\u003cp\\u003eTable 3: Changes in other measured parameters at baseline and after 12 months\\u003c/p\\u003e\\n\\u003ctable border=\\\"1\\\" cellspacing=\\\"0\\\" cellpadding=\\\"0\\\" width=\\\"623\\\"\\u003e\\n \\u003ctbody\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"12.01923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"9.134615384615385%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003eGroup A\\u0026nbsp;\\u003c/strong\\u003e(n=25)\\u003c/p\\u003e\\n \\u003cp\\u003eMV\\u0026plusmn;SD\\u003c/p\\u003e\\n \\u003cp\\u003eM (IQR)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ep-value\\u003c/p\\u003e\\n \\u003cp\\u003e(baseline-12 mo)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003eGroup B\\u0026nbsp;\\u003c/strong\\u003e(n=37)\\u003c/p\\u003e\\n \\u003cp\\u003eMV\\u0026plusmn;SD\\u003c/p\\u003e\\n \\u003cp\\u003eM (IQR)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ep-value\\u003c/p\\u003e\\n \\u003cp\\u003e(baseline-12 mo)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003eGroup C\\u0026nbsp;\\u003c/strong\\u003e(n=9)\\u003c/p\\u003e\\n \\u003cp\\u003eMV\\u0026plusmn;SD\\u003c/p\\u003e\\n \\u003cp\\u003eM (IQR)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ep-value\\u003c/p\\u003e\\n \\u003cp\\u003e(baseline-12 mo)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ep-value\\u003c/p\\u003e\\n \\u003cp\\u003e(between groups)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"12.01923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003eBMI\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e(kg/m2)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"9.134615384615385%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ebaseline\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e28.4\\u0026plusmn;5.0\\u003c/p\\u003e\\n \\u003cp\\u003e27.0 (5.0)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.360\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e25.5\\u0026plusmn;6.0\\u003c/p\\u003e\\n \\u003cp\\u003e24.2 (6.9)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.097\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e23.3\\u0026plusmn;5.3\\u003c/p\\u003e\\n \\u003cp\\u003e21.9 (3.2)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.652\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n 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rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.827\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e4.1\\u0026plusmn;1.3\\u003c/p\\u003e\\n \\u003cp\\u003e3.6 (1.7)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e1.000\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.463\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"16.23931623931624%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e12 mo\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e4.3\\u0026plusmn;0.8\\u003c/p\\u003e\\n \\u003cp\\u003e4.2 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valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e2.0\\u0026plusmn;1.3\\u003c/p\\u003e\\n \\u003cp\\u003e1.7 (1.4)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.594\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1.5\\u0026plusmn;0.8\\u003c/p\\u003e\\n \\u003cp\\u003e1.4 (0.9)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.700\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1.9\\u0026plusmn;2.3\\u003c/p\\u003e\\n \\u003cp\\u003e1.2 (0.7)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.800\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.128\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"16.23931623931624%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e12 mo\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1.9\\u0026plusmn;1.1\\u003c/p\\u003e\\n \\u003cp\\u003e1.8 (1.2)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1.4\\u0026plusmn;0.6\\u003c/p\\u003e\\n \\u003cp\\u003e1.4 (0.5)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1.6\\u0026plusmn;0.9\\u003c/p\\u003e\\n \\u003cp\\u003e1.4 (0.7)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.803418803418804%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.273\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"12.01923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003eCRP\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e(mg/L)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"9.134615384615385%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ebaseline\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e7.3\\u0026plusmn;14.6\\u003c/p\\u003e\\n \\u003cp\\u003e1.0 (6.0)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.224\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n 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\\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e10.4\\u0026plusmn;18.1\\u003c/p\\u003e\\n \\u003cp\\u003e6.0 (8.0)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e12.4\\u0026plusmn;15.2\\u003c/p\\u003e\\n \\u003cp\\u003e6.0 (14.0)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e24.4\\u0026plusmn;36.5\\u003c/p\\u003e\\n \\u003cp\\u003e13.0 (21.0)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.803418803418804%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.580\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"12.01923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ePotassium\\u0026nbsp;(mmol/L)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"9.134615384615385%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ebaseline\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e4.8\\u0026plusmn;0.5\\u003c/p\\u003e\\n \\u003cp\\u003e4.7 (0.6)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.696\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e4.7\\u0026plusmn;0.5\\u003c/p\\u003e\\n \\u003cp\\u003e4.7 (0.4)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.700\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e4.7\\u0026plusmn;0.5\\u003c/p\\u003e\\n \\u003cp\\u003e4.8 (0.6)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003e0.042\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.934\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"16.23931623931624%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e12 mo\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e4.7\\u0026plusmn;0.7\\u003c/p\\u003e\\n \\u003cp\\u003e4.7 (0.6)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e4.8\\u0026plusmn;0.7\\u003c/p\\u003e\\n \\u003cp\\u003e4.9 (0.7)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e4.9\\u0026plusmn;0.5\\u003c/p\\u003e\\n \\u003cp\\u003e5.0 (0.5)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.803418803418804%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.517\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"12.01923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ePhosphate\\u0026nbsp;(mmol/L)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"9.134615384615385%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003ebaseline\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1.7\\u0026plusmn;0.4\\u003c/p\\u003e\\n \\u003cp\\u003e1.6 (0.5)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.737\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1.5\\u0026plusmn;0.4\\u003c/p\\u003e\\n \\u003cp\\u003e1.4 (0.5)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.446\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"12.179487179487179%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1.5\\u0026plusmn;0.4\\u003c/p\\u003e\\n \\u003cp\\u003e1.6 (0.4)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" rowspan=\\\"2\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003e0.820\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"10.576923076923077%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.058\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd width=\\\"16.23931623931624%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e12 mo\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1.7\\u0026plusmn;0.5\\u003c/p\\u003e\\n \\u003cp\\u003e1.7 (0.6)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1.5\\u0026plusmn;0.5\\u003c/p\\u003e\\n \\u003cp\\u003e1.4 (0.4)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"21.65242165242165%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e1.6\\u0026plusmn;0.5\\u003c/p\\u003e\\n \\u003cp\\u003e1.7 (0.5)\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd width=\\\"18.803418803418804%\\\" valign=\\\"top\\\"\\u003e\\n \\u003cp\\u003e0.092\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003c/tbody\\u003e\\n\\u003c/table\\u003e\\n\\u003cp\\u003e12 mo = after 12 months; MV\\u0026plusmn;SD = mean value \\u0026plusmn; standard deviation; M = median; IQR = interquartile range; BMI = body mass index; WC = waist circumference; MAC = mid-arm circumference; MUAMC = mid-upper arm muscle circumference; FFMI = fat free mass index; DLM = dry lean mass; TIBC = total iron binding capacity; TG = triglycerides; CRP = C-reactive protein. P-values \\u0026lt;0.05 were considered statistically significant and are marked bold.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cbr\\u003e\\u003c/p\\u003e\"},{\"header\":\"DISCUSSION\",\"content\":\"\\u003cp\\u003eIn our real-life single-centre cohort study, we prospectively evaluated the effect of ONS on surrogate markers of NUS in HD patients. We did not find any statistically significant improvement after 12 months of intervention, although our preliminary results of short-term intervention suggested a possible positive effect of ONS on the preservation of NUS in HD patients\\u0026nbsp;(12). Data from two systematic reviews and a meta-analysis of randomised control trials showed mixed results regarding the effects of ONS on certain markers of NUS in HD patients, e.g. albumin, pre-albumin, MUAMC, TSFT, BMI, lean mass\\u0026nbsp;(4,13). Although albumin is not solely a marker of NUS and is influenced by many factors in HD patients (e.g. inflammation, overhydration, protein catabolism during HD session), it is still widely used as a traditional biochemical marker of NUS\\u0026nbsp;(14,15). Albumin has also persistently been correlated with morbidity and mortality in HD patients\\u0026nbsp;(8,16,17). In our study, serum albumin at baseline was significantly lower in groups B and C compared to group A, but there was no difference between groups B and C.\\u0026nbsp;During follow-up, we observed continuous statistically significant differences in serum albumin between groups but no change in serum albumin within group B, although patients were receiving ONS. There was a significant worsening of serum albumin in group A, where patients were evaluated as having normal NUS at baseline, indicating likely an important deterioration of overall health and NUS in these patients during a 12-monthperiod. PhA is derived from bioelectrical impedance analysis of body composition and reflects body cell mass and integrity. PhA has been shown to be altered in patients with chronic kidney disease of different stages\\u0026nbsp;(18). In HD patients, PhA correlates with certain nutritional markers, e.g. albumin, pre-albumin, fat-free mass, and MUAMC, and it has been shown to be a strong independent predictor of PEW\\u0026nbsp;(6,19). In our cohort of HD patients, we observed statistically significant differences in PhA between groups at baseline, consistent with their NUS. However, PhA has worsened at month 12 in group B, despite receiving ONS, again pointing to an important deterioration of body cell mass and integrity in this well-defined population of patients. Muscle function can, in clinical practice, be easily assessed using the HGS test. It is a simple, readily repeatable, reliable, non-invasive tool which has been shown to have a negative correlation with frequently used nutritional screening tools (e.g. SGA, MIS, BMI) and a positive correlation with other nutritional markers (e.g. PhA, fat-free mass and MAC)\\u0026nbsp;(20\\u0026ndash;22). HGS was also confirmed to be an independent predictor of all-cause mortality with a cut-off value of 22,5 kg for men and 7 kg for women independent of dialysis modality\\u0026nbsp;(21). Our study did not demonstrate a significant difference in HGS between groups at baseline. Furthermore, we observed no statistically significant change in HGS during follow-up in any of the groups.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003eOur results are do not align with published literature showing a positive effect of ONS on markers of NUS (1). On the other hand, a recent review in the Cochrane library and a meta-analysis of randomised controlled trials debate that there is still a lack of evidence concerning the effect of ONS on NUS in HD patients (4,13). We believe the intake of calories and protein with ONS in our group of patients was not sufficient. Recommended intake is 7-10 kcal of energy and 0.3-0.4 g of protein per kg of body weight per day, which target patients in our cohort could not reach (1,23). Another important issue may be the time of administration of ONS. In our study, patients received ONS after HD sessions, not intradialyticaly which would expectedly counteract the catabolic effect of HD (23,24). The reason for such an approach was the patient\\u0026rsquo;s convenience and desire to avoid potential side effects, mostly intradialytic hypotension and gastrointestinal symptoms, thus lowering adherence to ONS. A critical assessment of our results proved this approach to be questionable since adherence was still insufficient, which is, in our belief, the leading cause for the negative result of the study. Up to 50% of HD patients consume less than 1.0 g of protein/kg/ day with their regular diet and have insufficient dietary energy intake as well (3). In our cohort mean dietary energy intake was 1504.2\\u0026plusmn;484.9 kcal per day, and the median protein intake was 56.8 (IQR 23.3) g per day, and groups did not differ in dietary intake of energy or protein, presenting clearly that most patients in our cohort did not have a sufficient intake of nutrients with their regular diet. HD patients are inclined to continue following dietary restrictions recommended during the pre-dialysis period of chronic kidney failure. Nutritional counselling is therefore recommended as a first intervention (24,25). Such a basic intervention may be lacking in HD centres due to staff shortages, as in our centre. As a further consequence, one of the pivotal limitations of our study was volatile adherence to ONS. In HD patients\\u0026rsquo; low adherence to ONS is, in our opinion, a result of taste fatigue, lack of regular dietary consultations and an inclination towards reluctance and even depression in this group of patients. Systematic nutritional support with regular consultations with a clinical dietitian is expected to improve the NUS of HD patients receiving ONS (26). Furthermore, a systematic review of depression in HD patients reported high dietary non-adherence, ranging from 41.1 to as high as 98.3%, with a significant association between depressive symptoms and dietary non-adherence. The authors recommended early diagnosis and treatment of depression and close monitoring of adherence behaviour to enhance adherence and improve the quality of life and survival rates of HD patients (27). Finally, complementary and alternative medicine is also popular in the HD population, corresponding with dietary non-adherence (28,29). Acknowledging and addressing depression, complementary and alternative medicine may significantly influence dietary adherence in our cohort of HD patients, therefore, in the future additional efforts should be directed towards psychological evaluation and support.\\u0026nbsp;\\u003c/p\\u003e\"},{\"header\":\"CONCLUSIONS\",\"content\":\"\\u003cp\\u003eIn our cohort of HD patients, simply adding ONS to a regular diet did not improve surrogate markers of PEW. Further efforts must be directed into a timely and comprehensive nutritional approach, including systematic, personalized dietary counselling to increase protein and energy intake, advocating tight control of NUS during HD treatment and possibly providing psychological support and motivation.\\u003c/p\\u003e\"},{\"header\":\"Abbreviations\",\"content\":\"\\u003cp\\u003eAV; arterio-venous\\u003c/p\\u003e\\n\\u003cp\\u003eBIA; bioelectrical impedance analysis\\u003c/p\\u003e\\n\\u003cp\\u003eBMI; body mass index\\u003c/p\\u003e\\n\\u003cp\\u003eCRP; C-reactive protein\\u003c/p\\u003e\\n\\u003cp\\u003eDLM; dry lean mass\\u003c/p\\u003e\\n\\u003cp\\u003eFFMI; fat-free mass index\\u003c/p\\u003e\\n\\u003cp\\u003eHD; haemodialysis\\u003c/p\\u003e\\n\\u003cp\\u003eHGS; hand grip strength\\u003c/p\\u003e\\n\\u003cp\\u003eIQR; interquartile range\\u003c/p\\u003e\\n\\u003cp\\u003eISRNM; International Society of Renal Nutrition and Metabolism\\u003c/p\\u003e\\n\\u003cp\\u003eM; median\\u003c/p\\u003e\\n\\u003cp\\u003eMAC; mid-arm circumference\\u003c/p\\u003e\\n\\u003cp\\u003eMIS: malnutrition-inflammation score\\u003c/p\\u003e\\n\\u003cp\\u003eMUAMC; mid-upper arm muscle circumference\\u003c/p\\u003e\\n\\u003cp\\u003eMV; mean value\\u003c/p\\u003e\\n\\u003cp\\u003eNUS; nutritional status\\u003c/p\\u003e\\n\\u003cp\\u003eONS; oral nutritional supplementation\\u003c/p\\u003e\\n\\u003cp\\u003ePEW; protein-energy wasting\\u003c/p\\u003e\\n\\u003cp\\u003ePhA; phase angle\\u003c/p\\u003e\\n\\u003cp\\u003eSD; standard deviation\\u003c/p\\u003e\\n\\u003cp\\u003eSGA; subjective global assessment\\u003c/p\\u003e\\n\\u003cp\\u003eTIBC; total iron binding capacity\\u003c/p\\u003e\\n\\u003cp\\u003eTG; triglycerides\\u003c/p\\u003e\\n\\u003cp\\u003eTSFT; triceps skinfold thickness\\u003c/p\\u003e\\n\\u003cp\\u003eWC; waist circumference\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003e\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\"},{\"header\":\"Declarations\",\"content\":\"\\u003cp\\u003e\\u003cstrong\\u003eAcknowledgements\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eNot applicable.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAuthor Contribution\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eAO, PP and SB wrote the manuscript. AO was a major contributor in writing the manuscript. PP performed the statistical analysis. AO, PP and SB analysed and interpreted the statistical results. AO and PP created tables and figures. All authors\\u0026nbsp;reviewed\\u0026nbsp;and approved the final manuscript.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eFunding\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThis publication did not receive any external funding.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eData Availability\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eDatasets used in this article are available from corresponding author on reasonable request.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eEthics approval and consent to participate\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe study was approved by the National Ethics Committee of Slovenia and adhered to Helsinki Declaration (study registration number: 0120-664/2015-2) approved 11/01/2016. Informed consent was obtained from each patient at inclusion. All methods were performed in accordance with the relevant guidelines and regulations.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eConsent for publication\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eNot applicable.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eConflict of interest\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe authors have no conflicts of interest to declare.\\u003c/p\\u003e\"},{\"header\":\"References\",\"content\":\"\\u003col\\u003e\\n \\u003cli\\u003e\\u003cspan\\u003eIkizler TA, Cano NJ, Franch H, Fouque D, Himmelfarb J, Kalantar-Zadeh K et al. Prevention and treatment of protein energy wasting in chronic kidney disease patients: A consensus statement by the International Society of Renal Nutrition and Metabolism. Kidney Int [Internet]. 2013;84(6):1096\\u0026ndash;107. 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Nephrol Dial Transpl. 2004;19(6):1507\\u0026ndash;19.\\u003c/span\\u003e\\u003c/li\\u003e\\n \\u003cli\\u003e\\u003cspan\\u003eBellizzi V, Scalfi L, Terracciano V, De Nicola L, Minutolo R, Marra M, et al. Early changes in bioelectrical estimates of body composition in chronic kidney disease. J Am Soc Nephrol. 2006;17(5):1481\\u0026ndash;7.\\u003c/span\\u003e\\u003c/li\\u003e\\n \\u003cli\\u003e\\u003cspan\\u003eZhou H, Yao W, Pan D, Sun G. Predicational ability of phase angle on protein energy wasting in kidney disease patients with renal replacement therapy: A cross- \\u0026shy; sectional study.Food Sci Nutr. 2021;(April):3573\\u0026ndash;9.\\u003c/span\\u003e\\u003c/li\\u003e\\n \\u003cli\\u003e\\u003cspan\\u003eGarcia Ferreira M, Wazlawik E, Moreno YMF, Fuhr ML, Gonz\\u0026aacute;lez-Chica DA. Diagnostic accuracy of handgrip strength in the assessment of malnutrition in hemodialyzed patients. ESPEN J [Internet]. 2013;8(4):e181\\u0026ndash;6. 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Protein-energy wasting and nutritional supplementation in patients with end-stage renal disease on hemodialysis. Clin Nutr [Internet]. 2017;36(3):663\\u0026ndash;71. Available from: \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttp://dx.doi.org/10.1016/j.clnu.2016.06.007\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/li\\u003e\\n \\u003cli\\u003e\\u003cspan\\u003eSabatino A, Piotti G, Cosola C, Gandolfini I, Kooman JP, Fiaccadori E. Dietary protein and nutritional supplements in conventional hemodialysis. Semin Dial. 2018;31(6):583\\u0026ndash;91.\\u003c/span\\u003e\\u003c/li\\u003e\\n \\u003cli\\u003e\\u003cspan\\u003eJo I-Y, Kim WJ, Park HC, Choi HY, Lee JE, Lee SM. Effect of Personalized Nutritional Counseling on the Nutritional Status of Hemodialysis Patients. Clin Nutr Res. 2017;6(4):285.\\u003c/span\\u003e\\u003c/li\\u003e\\n \\u003cli\\u003e\\u003cspan\\u003eLimwannata P, Satirapoj B, Chotsriluecha S, Thimachai P, Supasyndh O. Effectiveness of renal-specific oral nutritional supplements compared with diet counseling in malnourished hemodialysis patients. Int Urol Nephrol [Internet]. 2021;53(8):1675\\u0026ndash;87. Available from: \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://doi.org/10.1007/s11255-020-02768-5\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/li\\u003e\\n \\u003cli\\u003e\\u003cspan\\u003eGebrie MH, Ford J. Depressive symptoms and dietary non-adherence among end stage renal disease patients undergoing hemodialysis therapy: Systematic review. BMC Nephrol. 2019;20(1):1\\u0026ndash;7.\\u003c/span\\u003e\\u003c/li\\u003e\\n \\u003cli\\u003e\\u003cspan\\u003eDuncan HJ, Pittman S, Govil A, Sorn L, Bissler G, Schultz T, et al. Alternative medicine use in dialysis patients: potential for good and bad! Nephron - Clinical Practice. 2007;105(3):108\\u0026ndash;13.\\u003c/span\\u003e\\u003c/li\\u003e\\n \\u003cli\\u003e\\u003cspan\\u003eIvetic CB, Klemenc-Ketis Z, Kersnik J. Use of complementary and alternative treatment methods among adults in Slovenia. ACTA MEDICO\\u0026ndash;BIOTECHNICA. 2013;6(1):51\\u0026ndash;8.\\u003c/span\\u003e\\u003c/li\\u003e\\n\\u003c/ol\\u003e\"}],\"fulltextSource\":\"\",\"fullText\":\"\",\"funders\":[],\"hasAdminPriorityOnWorkflow\":false,\"hasManuscriptDocX\":true,\"hasOptedInToPreprint\":true,\"hasPassedJournalQc\":\"\",\"hasAnyPriority\":false,\"hideJournal\":true,\"highlight\":\"\",\"institution\":\"\",\"isAcceptedByJournal\":false,\"isAuthorSuppliedPdf\":false,\"isDeskRejected\":\"\",\"isHiddenFromSearch\":false,\"isInQc\":false,\"isInWorkflow\":false,\"isPdf\":false,\"isPdfUpToDate\":true,\"isWithdrawnOrRetracted\":false,\"journal\":{\"display\":true,\"email\":\"info@researchsquare.com\",\"identity\":\"researchsquare\",\"isNatureJournal\":false,\"hasQc\":true,\"allowDirectSubmit\":true,\"externalIdentity\":\"\",\"sideBox\":\"\",\"snPcode\":\"\",\"submissionUrl\":\"/submission\",\"title\":\"Research Square\",\"twitterHandle\":\"researchsquare\",\"acdcEnabled\":true,\"dfaEnabled\":false,\"editorialSystem\":\"\",\"reportingPortfolio\":\"\",\"inReviewEnabled\":false,\"inReviewRevisionsEnabled\":true},\"keywords\":\"haemodialysis, protein-energy wasting, oral nutritional supplementation, serum albumin, phase angle, hand-grip strength test\",\"lastPublishedDoi\":\"10.21203/rs.3.rs-2728029/v1\",\"lastPublishedDoiUrl\":\"https://doi.org/10.21203/rs.3.rs-2728029/v1\",\"license\":{\"name\":\"CC BY 4.0\",\"url\":\"https://creativecommons.org/licenses/by/4.0/\"},\"manuscriptAbstract\":\"\\u003cp\\u003e\\u003cstrong\\u003eIntroduction:\\u003c/strong\\u003e Protein energy wasting (PEW) is a common and serious co-morbidity in haemodialysis patients. Its importance as a prognostic factor has been increasingly recognised during past decades. Much effort has been invested in the improvement of nutritional status and amelioration of consequences through different therapeutic approaches, either intradialytic parenteral nutrition or more commonly oral nutritional supplementation. In the article, we present the results of a prospective study in haemodialysis patients after 12 months of therapeutic intervention with ONS.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eMethods:\\u003c/strong\\u003e 92 HD adult patients were enrolled in the study after three months wash-out period. At baseline nutritional status was assessed using composite scores, laboratory markers, bioelectrical impedance analysis and hand-grip strength test. Patients recognised as undernourished or at high risk for undernutrition received renal-specific commercially available ONS on haemodialysis day in addition to their regular diet. After 12 months, the effect of ONS on surrogate markers of undernutrition, serum albumin level, phase angle and hand-grip strength was analysed in 71 surviving patients.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eResults:\\u003c/strong\\u003e After 12 months data for 71 patients, 39 (54.9%) male, 62.4±12.9 years, median haemodialysis vintage 53.3 (IQR 65.3) months, was available. Patients were divided into three groups: in group A were patients with normal nutritional status at baseline not necessitating ONS; in group B were patients who received ONS; and in group C were patients entitled to receive but refused to take ONS. Baseline results showed statistically significant differences between groups in serum albumin levels and phase angle but not hand-grip strength. Differences between groups remained statistically significant at month 12; we did not find any statistically significant positive changes within groups indicating no positive effect of intervention with ONS.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eConclusions:\\u003c/strong\\u003e In a prospectively designed interventional single-centre study, we did not find a statistically significant change of surrogate markers of PEW in our cohort of haemodialysis patients receiving ONS for 12 months. Since PEW is an independent risk factor influencing the survival of haemodialysis patients, efforts should be directed towards a timely and comprehensive nutritional approach, including intensive, personalised dietary counselling, increase in protein and energy intake and advocating tight control of nutritional status during haemodialysis treatment, possibly providing psychological support and motivation.\\u003c/p\\u003e\",\"manuscriptTitle\":\"Simply Adding Oral Nutritional Supplementation to Haemodialysis Patients May Not Be Enough: Real-life Prospective Interventional Study\",\"msid\":\"\",\"msnumber\":\"\",\"nonDraftVersions\":[{\"code\":1,\"date\":\"2023-05-16 17:22:57\",\"doi\":\"10.21203/rs.3.rs-2728029/v1\",\"editorialEvents\":[{\"type\":\"communityComments\",\"content\":0}],\"status\":\"published\",\"journal\":{\"display\":true,\"email\":\"info@researchsquare.com\",\"identity\":\"researchsquare\",\"isNatureJournal\":false,\"hasQc\":true,\"allowDirectSubmit\":true,\"externalIdentity\":\"\",\"sideBox\":\"\",\"snPcode\":\"\",\"submissionUrl\":\"/submission\",\"title\":\"Research Square\",\"twitterHandle\":\"researchsquare\",\"acdcEnabled\":true,\"dfaEnabled\":false,\"editorialSystem\":\"\",\"reportingPortfolio\":\"\",\"inReviewEnabled\":false,\"inReviewRevisionsEnabled\":true}}],\"origin\":\"\",\"ownerIdentity\":\"bfb22e5a-d2c9-44b7-8a25-b49466da0631\",\"owner\":[],\"postedDate\":\"May 16th, 2023\",\"published\":true,\"recentEditorialEvents\":[],\"rejectedJournal\":[],\"revision\":\"\",\"amendment\":\"\",\"status\":\"posted\",\"subjectAreas\":[],\"tags\":[],\"updatedAt\":\"2023-06-26T04:59:32+00:00\",\"versionOfRecord\":[],\"versionCreatedAt\":\"2023-05-16 17:22:57\",\"video\":\"\",\"vorDoi\":\"\",\"vorDoiUrl\":\"\",\"workflowStages\":[]},\"version\":\"v1\",\"identity\":\"rs-2728029\",\"journalConfig\":\"researchsquare\"},\"__N_SSP\":true},\"page\":\"/article/[identity]/[[...version]]\",\"query\":{\"redirect\":\"/article/rs-2728029\",\"identity\":\"rs-2728029\",\"version\":[\"v1\"]},\"buildId\":\"FbvkV6FR0MCFSLy54lSbu\",\"isFallback\":false,\"isExperimentalCompile\":false,\"dynamicIds\":[84888],\"gssp\":true,\"scriptLoader\":[]}","source_license":"CC-BY-4.0","license_restricted":false}