Pub Date : 2025-11-29DOI: 10.1016/j.clnu.2025.11.017
Emanuele Cereda , Valeria Borioli , Marilisa Caraccia , Anna Uggè , Francesca De Simeis , Raffaele Bruno , Angelo Guido Corsico , Antonio Di Sabatino , Paolo Pedrazzoli , Riccardo Caccialanza
Background
Acute diseases responsible for hospitalization negatively affect protein-calorie balance, as well as the capacity of patients to cope with it. In those who still retain spontaneous feeding, oral nutritional supplements (ONSs) administration is an effective support strategy, but evidence on the timing they should be provided along with nutritional counseling during hospitalization is lacking. Hence, we evaluated the efficacy of the systematic use of ONSs since hospital admission.
Methods
In a single-site, open-label, randomized, controlled trial (NCT02763904; July 2016–July 2024), acutely hospitalized adults (N = 220) at nutritional risk (NRS-2002 ≥ 3), without severe hypophagia (defined as food intake <50 % of estimated calorie requirements) and with an expected length of stay (LOS) ≥7 days were randomized to receive, along with nutritional counseling, high-protein ONSs systematically since admission or on-demand since day 8. The primary endpoint was the change in phase angle (PhA) on day 8. Secondary outcomes were the change in PhA at discharge and in muscle strength, body weight and protein-calorie intake over the hospital stay. LOS and the rate of acquired infections were also evaluated.
Results
A total of 201 patients were re-assessed at day 8 and at discharge. Systematic ONSs (n = 100) resulted in improved PhA at day 8 (mean difference, 0.47 [95%CI, 0.31–0.62]; P < 0.001) and at discharge (mean difference, 0.49 [95%CI, 0.33–0.64]; P < 0.001). A significant effect was also found for body weight and protein-calorie intake at all time-points (P < 0.001) and for muscle strength at discharge (P = 0.042). LOS was also reduced (−2 days; P = 0.044).
Conclusions
In acutely hospitalized adult patients at nutritional risk and without severe hypophagia, the systematic use of ONSs since admission improved body composition, muscle function, and protein-calorie intake, and reduced LOS.
{"title":"Systematic high-calorie, high-protein oral nutritional support in hospitalized, moderately hypophagic patients at nutritional risk: A randomized-controlled trial","authors":"Emanuele Cereda , Valeria Borioli , Marilisa Caraccia , Anna Uggè , Francesca De Simeis , Raffaele Bruno , Angelo Guido Corsico , Antonio Di Sabatino , Paolo Pedrazzoli , Riccardo Caccialanza","doi":"10.1016/j.clnu.2025.11.017","DOIUrl":"10.1016/j.clnu.2025.11.017","url":null,"abstract":"<div><h3>Background</h3><div>Acute diseases responsible for hospitalization negatively affect protein-calorie balance, as well as the capacity of patients to cope with it. In those who still retain spontaneous feeding, oral nutritional supplements (ONSs) administration is an effective support strategy, but evidence on the timing they should be provided along with nutritional counseling during hospitalization is lacking. Hence, we evaluated the efficacy of the systematic use of ONSs since hospital admission.</div></div><div><h3>Methods</h3><div>In a single-site, open-label, randomized, controlled trial (NCT02763904; July 2016–July 2024), acutely hospitalized adults (N = 220) at nutritional risk (NRS-2002 ≥ 3), without severe hypophagia (defined as food intake <50 % of estimated calorie requirements) and with an expected length of stay (LOS) ≥7 days were randomized to receive, along with nutritional counseling, high-protein ONSs systematically since admission or on-demand since day 8. The primary endpoint was the change in phase angle (PhA) on day 8. Secondary outcomes were the change in PhA at discharge and in muscle strength, body weight and protein-calorie intake over the hospital stay. LOS and the rate of acquired infections were also evaluated.</div></div><div><h3>Results</h3><div>A total of 201 patients were re-assessed at day 8 and at discharge. Systematic ONSs (n = 100) resulted in improved PhA at day 8 (mean difference, 0.47 [95%CI, 0.31–0.62]; P < 0.001) and at discharge (mean difference, 0.49 [95%CI, 0.33–0.64]; P < 0.001). A significant effect was also found for body weight and protein-calorie intake at all time-points (P < 0.001) and for muscle strength at discharge (P = 0.042). LOS was also reduced (−2 days; P = 0.044).</div></div><div><h3>Conclusions</h3><div>In acutely hospitalized adult patients at nutritional risk and without severe hypophagia, the systematic use of ONSs since admission improved body composition, muscle function, and protein-calorie intake, and reduced LOS.</div></div>","PeriodicalId":10517,"journal":{"name":"Clinical nutrition","volume":"56 ","pages":"Article 106532"},"PeriodicalIF":7.4,"publicationDate":"2025-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145760782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-29DOI: 10.1016/j.clnu.2025.11.007
Daniel Habich , Angela Horvath , Nicole Feldbacher , Lavra Rebol , Maximilian Nepel , Tobias Madl , Hans-Jörg Habisch , Franziska Baumann-Durchschein , Stefan Fürst , Johannes Plank , Florian Rainer , Walter Spindelböck , Rudolf E. Stauber , Elisabeth Tatscher , Martin Wagner , Gernot Zollner , Vanessa Stadlbauer
<div><h3>Background & Aims</h3><div>Liver cirrhosis is associated with gut microbiome dysbiosis, intestinal inflammation and gut barrier dysfunction, contributing to reduced quality of life and the development of complications. We showed in a retrospective study that <span>l</span>-ornithine-<span>l</span>-aspartate (LOLA) was associated with improvement in taxonomic composition of the microbiome. Here we prospectively studied the influence of LOLA on the gut microbiome, quality of life, sarcopenia and the gut barrier.</div></div><div><h3>Methods</h3><div>In this phase 4 study, patients with liver cirrhosis and hepatic encephalopathy grade 0–2 received LOLA 18 g/day orally for 3 months. We studied faecal microbiome composition (primary endpoint abundance of the genus <em>Flavonifractor)</em>, microbiome function, quality of life, serum ammonia levels, sarcopenia and frailty, biomarkers of the gut liver axis and the stool, serum and urine metabolome.</div></div><div><h3>Results</h3><div>We screened 258 patients with liver cirrhosis, included 65, of whom 52 patients (40 % female, age 62 (58; 65)) completed the study. LOLA intake decreased the abundance of the genus <em>Romboutsia</em>, increased the abundance of the genus <em>Enterococcus,</em> but did not alter other microbiome parameters. LOLA improved one out of 8 dimension of quality of life (vitality) and decreased serum ammonia concentrations. The subgroup of patients with improved ammonia concentrations responded with a halt in further muscle mass declined over the study period. Diamine oxidase, a marker of intestinal mucosal condition, decreased and LPS binding protein increased. Metabolomic analysis indicated an increase in alanine concentration.</div></div><div><h3>Conclusions</h3><div>LOLA improved one quality of life dimension (vitality) and biomarker of the gut–liver axis, altered innate immune response, faecal microbiome and metabolome. LOLA prevented muscle loss only in patients with elevated ammonia concentrations at baseline. LOLA may therefore be a useful adjunct treatment to improve quality of life in cirrhosis and a promising intervention for muscle loss prevention in hyperammonemic patients.</div></div><div><h3>Clinical Trials Registration number</h3><div>clinicaltrials.gov NCT05737030.</div></div><div><h3>Impact and implication</h3><div>We conducted a 12-week prospective cohort study to test the effect of the ammonia lowering drug <span>l</span>-ornithine-<span>l</span>-aspartate (LOLA) on the gut microbiome, biomarkers along the gut-liver-axis, muscle health and quality of life in patients with liver cirrhosis and hepatic encephalopathy. Although our primary endpoint was not reached, LOLA slightly altered microbiome composition and function and improved vitality, a clinically relevant patient reported outcome parameter. LOLA also improved biomarkers for the gut-liver-axis, innate immune response and prevented muscle loss in patients with elevated ammonia levels at baselin
{"title":"An observational study on the effect of l-ornithine-l-aspartate (LOLA) on the gut microbiome in liver cirrhosis. A single center phase 4 study","authors":"Daniel Habich , Angela Horvath , Nicole Feldbacher , Lavra Rebol , Maximilian Nepel , Tobias Madl , Hans-Jörg Habisch , Franziska Baumann-Durchschein , Stefan Fürst , Johannes Plank , Florian Rainer , Walter Spindelböck , Rudolf E. Stauber , Elisabeth Tatscher , Martin Wagner , Gernot Zollner , Vanessa Stadlbauer","doi":"10.1016/j.clnu.2025.11.007","DOIUrl":"10.1016/j.clnu.2025.11.007","url":null,"abstract":"<div><h3>Background & Aims</h3><div>Liver cirrhosis is associated with gut microbiome dysbiosis, intestinal inflammation and gut barrier dysfunction, contributing to reduced quality of life and the development of complications. We showed in a retrospective study that <span>l</span>-ornithine-<span>l</span>-aspartate (LOLA) was associated with improvement in taxonomic composition of the microbiome. Here we prospectively studied the influence of LOLA on the gut microbiome, quality of life, sarcopenia and the gut barrier.</div></div><div><h3>Methods</h3><div>In this phase 4 study, patients with liver cirrhosis and hepatic encephalopathy grade 0–2 received LOLA 18 g/day orally for 3 months. We studied faecal microbiome composition (primary endpoint abundance of the genus <em>Flavonifractor)</em>, microbiome function, quality of life, serum ammonia levels, sarcopenia and frailty, biomarkers of the gut liver axis and the stool, serum and urine metabolome.</div></div><div><h3>Results</h3><div>We screened 258 patients with liver cirrhosis, included 65, of whom 52 patients (40 % female, age 62 (58; 65)) completed the study. LOLA intake decreased the abundance of the genus <em>Romboutsia</em>, increased the abundance of the genus <em>Enterococcus,</em> but did not alter other microbiome parameters. LOLA improved one out of 8 dimension of quality of life (vitality) and decreased serum ammonia concentrations. The subgroup of patients with improved ammonia concentrations responded with a halt in further muscle mass declined over the study period. Diamine oxidase, a marker of intestinal mucosal condition, decreased and LPS binding protein increased. Metabolomic analysis indicated an increase in alanine concentration.</div></div><div><h3>Conclusions</h3><div>LOLA improved one quality of life dimension (vitality) and biomarker of the gut–liver axis, altered innate immune response, faecal microbiome and metabolome. LOLA prevented muscle loss only in patients with elevated ammonia concentrations at baseline. LOLA may therefore be a useful adjunct treatment to improve quality of life in cirrhosis and a promising intervention for muscle loss prevention in hyperammonemic patients.</div></div><div><h3>Clinical Trials Registration number</h3><div>clinicaltrials.gov NCT05737030.</div></div><div><h3>Impact and implication</h3><div>We conducted a 12-week prospective cohort study to test the effect of the ammonia lowering drug <span>l</span>-ornithine-<span>l</span>-aspartate (LOLA) on the gut microbiome, biomarkers along the gut-liver-axis, muscle health and quality of life in patients with liver cirrhosis and hepatic encephalopathy. Although our primary endpoint was not reached, LOLA slightly altered microbiome composition and function and improved vitality, a clinically relevant patient reported outcome parameter. LOLA also improved biomarkers for the gut-liver-axis, innate immune response and prevented muscle loss in patients with elevated ammonia levels at baselin","PeriodicalId":10517,"journal":{"name":"Clinical nutrition","volume":"56 ","pages":"Article 106522"},"PeriodicalIF":7.4,"publicationDate":"2025-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145760785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-22DOI: 10.1016/j.clnu.2025.11.014
Robert Martindale , Manpreet S. Mundi , Dan Waitzberg , Elisabeth De Waele , Marialaura Scarcella , Michele Umbrello , Philip C. Calder , Jesmond Dalli , Zudin Puthucheary , Arthur R.H. van Zanten
Acute inflammation is a crucial biological response necessary for host defense and tissue repair, but unresolved inflammation can contribute to adverse outcomes across critical illness, cardiovascular disease, neurodegeneration, and cancer. Emerging evidence emphasizes that the resolution of inflammation is an active biosynthetic process mediated in part by specialized pro-resolving mediators (SPMs), lipid-derived molecules generated from omega-3 polyunsaturated fatty acids (PUFAs) such as eicosapentaenoic acid (C20:5n-3, EPA) and docosahexaenoic acid (C22:6n-3, DHA). These mediators—including resolvins, protectins, and maresins—exert potent immunomodulatory actions that restore tissue homeostasis and attenuate inflammation without immunosuppression. Despite the established role of SPMs, clinical and preclinical studies demonstrate that SPM biosynthesis is often impaired in disease states, limiting the efficacy of omega-3 PUFA-based nutritional interventions. To explore the potential of standardized SPM enrichment in enteral nutrition (EN), a multidisciplinary panel of experts conducted a Delphi-based consensus process. Consensus statements were developed supporting the rationale for enriching EN with preformed SPMs or their stable precursors to overcome compromised endogenous biosynthesis and enhance clinical benefits. Preliminary human studies suggest that such enrichment may reduce inflammation, improve immune function, and contribute to better outcomes in conditions such as obesity, atherosclerosis, infections, and chronic pain. The panel emphasized the need for rigorously designed clinical trials to determine whether enteral SPMs have measurable clinical effects and, if so, to define effective dosing strategies. Overall, SPM-enriched EN represents a potential advancement in the nutritional modulation of inflammation, warranting further investigation to guide evidence-based clinical application.
{"title":"Integrating downstream mediators of Omega-3 fatty acids into enteral nutrition for improved patient care: An expert panel consensus","authors":"Robert Martindale , Manpreet S. Mundi , Dan Waitzberg , Elisabeth De Waele , Marialaura Scarcella , Michele Umbrello , Philip C. Calder , Jesmond Dalli , Zudin Puthucheary , Arthur R.H. van Zanten","doi":"10.1016/j.clnu.2025.11.014","DOIUrl":"10.1016/j.clnu.2025.11.014","url":null,"abstract":"<div><div>Acute inflammation is a crucial biological response necessary for host defense and tissue repair, but unresolved inflammation can contribute to adverse outcomes across critical illness, cardiovascular disease, neurodegeneration, and cancer. Emerging evidence emphasizes that the resolution of inflammation is an active biosynthetic process mediated in part by specialized pro-resolving mediators (SPMs), lipid-derived molecules generated from omega-3 polyunsaturated fatty acids (PUFAs) such as eicosapentaenoic acid (C20:5n-3, EPA) and docosahexaenoic acid (C22:6n-3, DHA). These mediators—including resolvins, protectins, and maresins—exert potent immunomodulatory actions that restore tissue homeostasis and attenuate inflammation without immunosuppression. Despite the established role of SPMs, clinical and preclinical studies demonstrate that SPM biosynthesis is often impaired in disease states, limiting the efficacy of omega-3 PUFA-based nutritional interventions. To explore the potential of standardized SPM enrichment in enteral nutrition (EN), a multidisciplinary panel of experts conducted a Delphi-based consensus process. Consensus statements were developed supporting the rationale for enriching EN with preformed SPMs or their stable precursors to overcome compromised endogenous biosynthesis and enhance clinical benefits. Preliminary human studies suggest that such enrichment may reduce inflammation, improve immune function, and contribute to better outcomes in conditions such as obesity, atherosclerosis, infections, and chronic pain. The panel emphasized the need for rigorously designed clinical trials to determine whether enteral SPMs have measurable clinical effects and, if so, to define effective dosing strategies. Overall, SPM-enriched EN represents a potential advancement in the nutritional modulation of inflammation, warranting further investigation to guide evidence-based clinical application.</div></div>","PeriodicalId":10517,"journal":{"name":"Clinical nutrition","volume":"56 ","pages":"Article 106529"},"PeriodicalIF":7.4,"publicationDate":"2025-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145760803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<div><h3>Background and aims</h3><div>Cachexia, which is a complex metabolic disorder that is characterized by weight loss, muscle atrophy, and inflammation, is commonly associated with chronic diseases. However, the occurrence of cachexia among community-dwelling, middle-aged and older adults remains underexplored. This study aimed to assess the associations among cachexia, intrinsic capacity (IC) impairment, and mortality in adults aged 50 years and older.</div></div><div><h3>Methods</h3><div>We pooled data from three longitudinal cohort studies, which included 3112 individuals aged 50 years and older. The cachexia phenotype was defined using two algorithms suggested by the Asian Working Group for Cachexia (AWGC), even in the absence of specific index diseases. For Algorithm 1, patients were identified as having cachexia when they presented with weight loss or low body mass index (BMI) combined with one of the following: anorexia, decreased grip strength, or elevated C-reactive protein (CRP) levels. For Algorithm 2, the identification of cachexia required elevated CRP levels, along with weight loss or low BMI, combined with either anorexia or decreased grip strength. Importantly, the presence of a specific index disease was not necessary to define the cachexia phenotype using these criteria. Instead, we screened for the following index diseases as comorbid conditions: malignancy, congestive heart failure, chronic pulmonary disease, chronic kidney disease, severe liver disease, rheumatic or immune diseases, and acquired immunodeficiency syndrome (AIDS). IC was evaluated using the World Health Organization’s ICOPE framework (Step 1 screening; Step 2 in-depth assessment), which includes six domains: locomotor, vitality, vision, hearing, cognition, and psychological capacity. Logistic regression was used to assess the association between cachexia and IC impairment, and Cox proportional hazard models were used to examine the effect of cachexia on all-cause mortality.</div></div><div><h3>Results</h3><div>Among 3112 participants (median age 68.8 years, 43.7 % male) in the three cohorts, 5.4 % of participants were identified as having the cachexia phenotype using Algorithm 1, whereas only 0.4 % met the criteria for Algorithm 2. Notably, only 22 % of the participants with the cachexia phenotype (Algorithm 1) had at least one of the screened index diseases compared with 12 % in the non-cachexia group (<em>p</em> < 0.001). These findings demonstrate that the cachexia phenotype can be identified even in the absence of specific index diseases. The cachexia phenotype was significantly associated with impairments in multiple IC domains, including vitality (Step 1: aOR 8.44 [95 % CI 5.15–13.83], <em>p</em> < 0.001; Step 2: aOR 15.89 [10.72–23.56], <em>p</em> < 0.001), cognition (Step 1: aOR 1.75 [1.17–2.62], <em>p</em> = 0.007), and psychological capacity (Step 2: aOR 2.56 [1.39–4.73], <em>p</em> = 0.003). Individuals with the cachexia phenotype had a
背景和目的苦胆病是一种复杂的代谢紊乱,以体重减轻、肌肉萎缩和炎症为特征,通常与慢性疾病相关。然而,恶病质在社区居民、中老年人中的发生情况仍未得到充分研究。本研究旨在评估50岁及以上成人恶病质、内在能力(IC)损伤和死亡率之间的关系。方法:我们汇集了三项纵向队列研究的数据,其中包括3112名年龄在50岁及以上的个体。使用亚洲恶病质工作组(AWGC)提出的两种算法定义恶病质表型,即使在没有特定指数疾病的情况下。对于算法1,当患者出现体重减轻或低体重指数(BMI)并伴有以下情况之一时,患者被确定为患有恶病质:厌食症、握力下降或c反应蛋白(CRP)水平升高。对于算法2,识别恶病质需要CRP水平升高,同时体重减轻或低BMI,并伴有厌食症或握力下降。重要的是,使用这些标准来定义恶病质表型并不需要特定指数疾病的存在。相反,我们筛选了以下指标疾病作为合并症:恶性肿瘤,充血性心力衰竭,慢性肺病,慢性肾病,严重肝病,风湿病或免疫疾病,以及获得性免疫缺陷综合征(艾滋病)。使用世界卫生组织的ICOPE框架(第1步筛查;第2步深入评估)对IC进行评估,其中包括六个领域:运动、活力、视觉、听觉、认知和心理能力。采用Logistic回归评估恶病质与IC损伤之间的关系,采用Cox比例风险模型检验恶病质对全因死亡率的影响。结果在三个队列的3112名参与者(中位年龄68.8岁,43.7%为男性)中,使用算法1确定5.4%的参与者具有恶病质表型,而只有0.4%的参与者符合算法2的标准。值得注意的是,只有22%的具有恶病质表型(算法1)的参与者至少有一种筛查的指标疾病,而非恶病质组的这一比例为12% (p < 0.001)。这些发现表明,即使在没有特定指数疾病的情况下,恶病质表型也可以被识别。恶病质表型与多个IC领域的损伤显著相关,包括活力(步骤1:aOR 8.44 [95% CI 5.15-13.83], p < 0.001;步骤2:aOR 15.89 [10.72-23.56], p < 0.001)、认知(步骤1:aOR 1.75 [1.17-2.62], p = 0.007)和心理能力(步骤2:aOR 2.56 [1.39-4.73], p = 0.003)。校正混杂因素后,恶病质表型个体的死亡风险显著高于非恶病质组(aHR 1.77 [95% CI 1.15-2.73], p = 0.010)。结论在没有特定指标疾病的情况下,恶病质表型与中老年人IC损伤和死亡率增加有关。早期识别和有针对性的干预对于减轻恶病质表型患者的功能衰退和提高生存率至关重要。
{"title":"Cachexia phenotype in community-dwelling, middle-aged and older adults and its impacts on intrinsic capacity and mortality: A pooled analysis of three cohorts","authors":"Liang-Kung Chen , Chi-Yun Wu , Wei-Ju Lee , Li-Ning Peng , Pi-Shan Hsu , Fei-Yuan Hsiao","doi":"10.1016/j.clnu.2025.11.011","DOIUrl":"10.1016/j.clnu.2025.11.011","url":null,"abstract":"<div><h3>Background and aims</h3><div>Cachexia, which is a complex metabolic disorder that is characterized by weight loss, muscle atrophy, and inflammation, is commonly associated with chronic diseases. However, the occurrence of cachexia among community-dwelling, middle-aged and older adults remains underexplored. This study aimed to assess the associations among cachexia, intrinsic capacity (IC) impairment, and mortality in adults aged 50 years and older.</div></div><div><h3>Methods</h3><div>We pooled data from three longitudinal cohort studies, which included 3112 individuals aged 50 years and older. The cachexia phenotype was defined using two algorithms suggested by the Asian Working Group for Cachexia (AWGC), even in the absence of specific index diseases. For Algorithm 1, patients were identified as having cachexia when they presented with weight loss or low body mass index (BMI) combined with one of the following: anorexia, decreased grip strength, or elevated C-reactive protein (CRP) levels. For Algorithm 2, the identification of cachexia required elevated CRP levels, along with weight loss or low BMI, combined with either anorexia or decreased grip strength. Importantly, the presence of a specific index disease was not necessary to define the cachexia phenotype using these criteria. Instead, we screened for the following index diseases as comorbid conditions: malignancy, congestive heart failure, chronic pulmonary disease, chronic kidney disease, severe liver disease, rheumatic or immune diseases, and acquired immunodeficiency syndrome (AIDS). IC was evaluated using the World Health Organization’s ICOPE framework (Step 1 screening; Step 2 in-depth assessment), which includes six domains: locomotor, vitality, vision, hearing, cognition, and psychological capacity. Logistic regression was used to assess the association between cachexia and IC impairment, and Cox proportional hazard models were used to examine the effect of cachexia on all-cause mortality.</div></div><div><h3>Results</h3><div>Among 3112 participants (median age 68.8 years, 43.7 % male) in the three cohorts, 5.4 % of participants were identified as having the cachexia phenotype using Algorithm 1, whereas only 0.4 % met the criteria for Algorithm 2. Notably, only 22 % of the participants with the cachexia phenotype (Algorithm 1) had at least one of the screened index diseases compared with 12 % in the non-cachexia group (<em>p</em> < 0.001). These findings demonstrate that the cachexia phenotype can be identified even in the absence of specific index diseases. The cachexia phenotype was significantly associated with impairments in multiple IC domains, including vitality (Step 1: aOR 8.44 [95 % CI 5.15–13.83], <em>p</em> < 0.001; Step 2: aOR 15.89 [10.72–23.56], <em>p</em> < 0.001), cognition (Step 1: aOR 1.75 [1.17–2.62], <em>p</em> = 0.007), and psychological capacity (Step 2: aOR 2.56 [1.39–4.73], <em>p</em> = 0.003). Individuals with the cachexia phenotype had a","PeriodicalId":10517,"journal":{"name":"Clinical nutrition","volume":"56 ","pages":"Article 106526"},"PeriodicalIF":7.4,"publicationDate":"2025-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145838345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-13DOI: 10.1016/j.clnu.2025.11.001
Tommy Cederholm, Rocco Barazzoni, Elisabet Rothenberg, Kremlin Wickramasinghe, Cristina Cuerda, Stéphane Schneider, Stanislaw Klek
{"title":"A new diagnosis code in ICD-11 for Undernutrition in Adults – A historic achievement for the clinical nutrition community","authors":"Tommy Cederholm, Rocco Barazzoni, Elisabet Rothenberg, Kremlin Wickramasinghe, Cristina Cuerda, Stéphane Schneider, Stanislaw Klek","doi":"10.1016/j.clnu.2025.11.001","DOIUrl":"10.1016/j.clnu.2025.11.001","url":null,"abstract":"","PeriodicalId":10517,"journal":{"name":"Clinical nutrition","volume":"55 ","pages":"Pages 219-221"},"PeriodicalIF":7.4,"publicationDate":"2025-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145573253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-05DOI: 10.1016/j.clnu.2025.10.022
Kensuke Nakamura , Hidehiko Nakano , Naoki Kanda
Background and aims
One potential adverse effect of protein loading in critically ill patients is elevated blood urea nitrogen (BUN) concentrations. Along with kidney function, we hypothesized that muscle volume also affects the BUN trajectory with protein administration.
Methods
A post-hoc analysis was conducted of a prospective historical control study in which intensive care unit (ICU) patients were assigned to protein delivery targets of 0.9 and 1.8 g/kg/day over 10 days. Patients who received renal replacement therapy were excluded. Femoral muscle volume FMV was evaluated by computed tomography on ICU admission. Daily BUN and protein delivery were recorded throughout the 10 days.
Results
Eighty-two eligible patients were analyzed. The BUN trajectories were slightly higher in patients with a lower muscle volume. The relative ratio of total protein delivery over 10 days to FMV showed a positive correlation with the BUN concentration on day 10 (r = 0.37, p = 0.0007); while this relationship was not significant with protein intake to actual body weight (r = 0.22, p = 0.068). In the linear mixed-effects model, protein intake per FMV was significantly associated with higher blood BUN concentrations (coefficient 0.07, 95 % CI 0.01 to 0.13, p = 0.02). Simultaneously, age and baseline creatinine were also significant predictors of BUN concentrations.
Conclusions
In critically ill patients, the relative ratio of total protein delivery to muscle volume was associated with BUN elevations. Protein targets may be more appropriately set based on muscle volume, for example, by using the grams per fat-free mass calculation.
Registration
The present study is registered at the University Hospital Medical Information Network-clinical trials registry (UMIN000040290, Registration date: May 7, 2020); https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045970.
背景和目的:危重患者蛋白质负荷的一个潜在不良影响是血尿素氮(BUN)浓度升高。除了肾功能外,我们假设肌肉体积也会影响蛋白质给药后的BUN轨迹。方法:对一项前瞻性历史对照研究进行事后分析,在该研究中,重症监护病房(ICU)患者在10天内被分配到0.9和1.8 g/kg/天的蛋白质递送目标。接受肾脏替代治疗的患者排除在外。在ICU入院时通过计算机断层扫描评估股骨肌体积FMV。在10天内记录每日BUN和蛋白质递送量。结果:分析了82例符合条件的患者。在肌肉体积较小的患者中,BUN轨迹略高。10 d总蛋白递送量与FMV的相对比值与第10 d BUN浓度呈正相关(r = 0.37, p = 0.0007);而蛋白质摄入量与实际体重之间的关系不显著(r = 0.22, p = 0.068)。在线性混合效应模型中,每FMV蛋白质摄入量与较高的血尿素氮浓度显著相关(系数0.07,95% CI 0.01 ~ 0.13, p = 0.02)。同时,年龄和基线肌酐也是BUN浓度的重要预测因子。结论:危重患者总蛋白递送量与肌肉体积的相对比值与BUN升高有关。蛋白质目标可能更适合根据肌肉体积来设定,例如,通过使用克/无脂质量计算。注册:本研究在大学医院医学信息网临床试验注册中心注册(UMIN000040290,注册日期:2020年5月7日);https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045970。
{"title":"Optimizing protein in critical illness: Is g/fat-free mass the key?","authors":"Kensuke Nakamura , Hidehiko Nakano , Naoki Kanda","doi":"10.1016/j.clnu.2025.10.022","DOIUrl":"10.1016/j.clnu.2025.10.022","url":null,"abstract":"<div><h3>Background and aims</h3><div>One potential adverse effect of protein loading in critically ill patients is elevated blood urea nitrogen (BUN) concentrations. Along with kidney function, we hypothesized that muscle volume also affects the BUN trajectory with protein administration.</div></div><div><h3>Methods</h3><div>A post-hoc analysis was conducted of a prospective historical control study in which intensive care unit (ICU) patients were assigned to protein delivery targets of 0.9 and 1.8 g/kg/day over 10 days. Patients who received renal replacement therapy were excluded. Femoral muscle volume FMV was evaluated by computed tomography on ICU admission. Daily BUN and protein delivery were recorded throughout the 10 days.</div></div><div><h3>Results</h3><div>Eighty-two eligible patients were analyzed. The BUN trajectories were slightly higher in patients with a lower muscle volume. The relative ratio of total protein delivery over 10 days to FMV showed a positive correlation with the BUN concentration on day 10 (r = 0.37, p = 0.0007); while this relationship was not significant with protein intake to actual body weight (r = 0.22, p = 0.068). In the linear mixed-effects model, protein intake per FMV was significantly associated with higher blood BUN concentrations (coefficient 0.07, 95 % CI 0.01 to 0.13, p = 0.02). Simultaneously, age and baseline creatinine were also significant predictors of BUN concentrations.</div></div><div><h3>Conclusions</h3><div>In critically ill patients, the relative ratio of total protein delivery to muscle volume was associated with BUN elevations. Protein targets may be more appropriately set based on muscle volume, for example, by using the grams per fat-free mass calculation.</div></div><div><h3>Registration</h3><div>The present study is registered at the University Hospital Medical Information Network-clinical trials registry (UMIN000040290, Registration date: May 7, 2020); <span><span>https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045970</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10517,"journal":{"name":"Clinical nutrition","volume":"55 ","pages":"Pages 189-195"},"PeriodicalIF":7.4,"publicationDate":"2025-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145511665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-03DOI: 10.1016/j.clnu.2025.10.021
Francesco Campa , A. Sampieri , G. Cerullo , L. Zoffoli , G. Coratella , Antonio Paoli
Background and aims
Disagreement between bioelectrical impedance analysis (BIA) technologies in measuring resistance (R), reactance (Xc), and phase angle (PhA) is well documented and mainly due to device-specific features. Whether such a variability translates into differences in body composition estimates remains uncertain. This study evaluated agreement in fat-free mass (FFM) estimates from different BIA technologies against dual-energy X-ray absorptiometry (DXA), while accounting for the role of predictive equations. Additionally, agreement of BIA-based fat mass (FM), indirectly calculated from FFM, was assessed.
Methods
A total of 288 adults (167 men, 37.2 ± 18.7 y, BMI 23.0 ± 3.1 kg/m2; 121 women, 33.8 ± 16.8 y, BMI 25.1 ± 3.3 kg/m2) participated in this study. Whole-body foot-to-hand and direct segmental BIA at 50 kHz measured R, Xc, and PhA. DXA served as the reference. Predictive equations for FFM were developed by stepwise regression in two-thirds of the sample and validated in the remaining third. Agreement was evaluated between BIA technologies and against DXA using Bland–Altman and Lin's concordance correlation coefficient.
Results
Foot-to-hand BIA yielded lower R (p < 0.001) but higher Xc and PhA (p < 0.001) than direct segmental BIA. Despite these differences, no significant bias (p > 0.05) was observed in FFM estimation across devices. Concordance analyses indicated high agreement without systematic deviations. FM derived from FFM agreed with DXA at a group level but showed systematic trends at the individual level.
Conclusions
Although raw bioelectrical parameters differ between technologies, FFM estimates can be comparable when equations are derived within the same population and reference method. However, FM indirectly obtained from FFM lacks accuracy at the individual level.
背景和目的生物电阻抗分析(BIA)技术在测量电阻(R)、电抗(Xc)和相角(PhA)方面的分歧是有案可查的,主要是由于器件的特定特性。这种差异是否会转化为身体成分估计值的差异仍不确定。本研究评估了不同BIA技术对双能x射线吸收测定法(DXA)的无脂质量(FFM)估计值的一致性,同时考虑了预测方程的作用。此外,评估了从FFM间接计算的基于bia的脂肪量(FM)的一致性。方法共288例成人(男性167例,37.2±18.7 y, BMI 23.0±3.1 kg/m2);女性121例,33.8±16.8 y, BMI 25.1±3.3 kg/m2)。在50 kHz下,全身脚到手和直接节段BIA测量R, Xc和PhA。DXA作为参考。在三分之二的样本中,通过逐步回归建立了FFM的预测方程,并在其余三分之一的样本中进行了验证。使用Bland-Altman和Lin的一致性相关系数评估BIA技术与DXA的一致性。结果与直接节段BIA相比,脚-手BIA的R值较低(p < 0.001),而Xc和PhA值较高(p < 0.001)。尽管存在这些差异,但在不同设备的FFM估计中未观察到显著偏差(p > 0.05)。一致性分析显示一致性高,无系统偏差。从FFM得到的FM在群体水平上与DXA一致,但在个体水平上表现出系统的趋势。结论虽然不同技术的原始生物电参数不同,但在相同人群和参考方法中推导方程时,FFM估计值是可以比较的。然而,从FFM间接获得的FM在个体层面上缺乏准确性。
{"title":"Determining body composition using different bioimpedance technologies: Is an agreement possible?","authors":"Francesco Campa , A. Sampieri , G. Cerullo , L. Zoffoli , G. Coratella , Antonio Paoli","doi":"10.1016/j.clnu.2025.10.021","DOIUrl":"10.1016/j.clnu.2025.10.021","url":null,"abstract":"<div><h3>Background and aims</h3><div>Disagreement between bioelectrical impedance analysis (BIA) technologies in measuring resistance (R), reactance (Xc), and phase angle (PhA) is well documented and mainly due to device-specific features. Whether such a variability translates into differences in body composition estimates remains uncertain. This study evaluated agreement in fat-free mass (FFM) estimates from different BIA technologies against dual-energy X-ray absorptiometry (DXA), while accounting for the role of predictive equations. Additionally, agreement of BIA-based fat mass (FM), indirectly calculated from FFM, was assessed.</div></div><div><h3>Methods</h3><div>A total of 288 adults (167 men, 37.2 ± 18.7 y, BMI 23.0 ± 3.1 kg/m<sup>2</sup>; 121 women, 33.8 ± 16.8 y, BMI 25.1 ± 3.3 kg/m<sup>2</sup>) participated in this study. Whole-body foot-to-hand and direct segmental BIA at 50 kHz measured R, Xc, and PhA. DXA served as the reference. Predictive equations for FFM were developed by stepwise regression in two-thirds of the sample and validated in the remaining third. Agreement was evaluated between BIA technologies and against DXA using Bland–Altman and Lin's concordance correlation coefficient.</div></div><div><h3>Results</h3><div>Foot-to-hand BIA yielded lower R (p < 0.001) but higher Xc and PhA (p < 0.001) than direct segmental BIA. Despite these differences, no significant bias (p > 0.05) was observed in FFM estimation across devices. Concordance analyses indicated high agreement without systematic deviations. FM derived from FFM agreed with DXA at a group level but showed systematic trends at the individual level.</div></div><div><h3>Conclusions</h3><div>Although raw bioelectrical parameters differ between technologies, FFM estimates can be comparable when equations are derived within the same population and reference method. However, FM indirectly obtained from FFM lacks accuracy at the individual level.</div></div>","PeriodicalId":10517,"journal":{"name":"Clinical nutrition","volume":"55 ","pages":"Pages 180-188"},"PeriodicalIF":7.4,"publicationDate":"2025-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145475504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01DOI: 10.1016/j.clnu.2025.10.017
Michelle A.J. van Oeteren , David M. de Groot , Amée M. Buziau , Jean L.J.M. Scheijen , Marjo P.H. van de Waarenburg , Abraham A. Kroon , Simone J.P.M. Eussen , Pieter C. Dagnelie , Marleen M.J. van Greevenbroek , Alfons J.H.M. Houben , Steven J.R. Meex , Casper G. Schalkwijk , Martijn C.G.J. Brouwers
Background and aims
Fruits and sugar-sweetened beverages have opposing effects on cardiometabolic health, despite comparable amounts of fructose per serving. Here, we sought evidence for a role of the food matrix in modifying serum fructose dynamics and blood pressure.
Methods
We first performed multiple linear regression analyses to assess the association between energy-adjusted intake of fructose from different sources (total, fruit, fruit juice and sugar-sweetened beverages) and blood pressure (24-h ambulatory, 7-day ambulatory, and office) using data from The Maastricht Study, a large population-based cohort (n = 5,426–6,471). Next, we conducted a randomized crossover trial in which healthy individuals (n = 21) were exposed to a fixed amount of fructose (20g) from different matrices (apple, mashed apple, apple juice, and fructose dissolved in water), and measured the serum fructose and blood pressure response.
Results
The intake of fructose from sugar-sweetened beverages, but not from fruits or fruit juice, was associated with higher ambulatory 7-day mean blood pressure, higher office blood pressure, and greater risk of hypertension (OR: 1.29, 95%CI 1.12; 1.50 per 10g fructose). In the crossover study, pure fructose intake yielded the greatest serum fructose excursions (p < 0.05 for all comparisons). The systolic blood pressure response was higher after pure fructose compared to the other matrices (+1.8 mmHg, 95%CI 0.02; 3.5).
Conclusions
Here, we provide epidemiological and experimental evidence that highlights the relevance of the food matrix on fructose dynamics and blood pressure, independent of the caloric value of fructose.
{"title":"The effects of dietary fructose on blood pressure are modified by the food matrix","authors":"Michelle A.J. van Oeteren , David M. de Groot , Amée M. Buziau , Jean L.J.M. Scheijen , Marjo P.H. van de Waarenburg , Abraham A. Kroon , Simone J.P.M. Eussen , Pieter C. Dagnelie , Marleen M.J. van Greevenbroek , Alfons J.H.M. Houben , Steven J.R. Meex , Casper G. Schalkwijk , Martijn C.G.J. Brouwers","doi":"10.1016/j.clnu.2025.10.017","DOIUrl":"10.1016/j.clnu.2025.10.017","url":null,"abstract":"<div><h3>Background and aims</h3><div>Fruits and sugar-sweetened beverages have opposing effects on cardiometabolic health, despite comparable amounts of fructose per serving. Here, we sought evidence for a role of the food matrix in modifying serum fructose dynamics and blood pressure.</div></div><div><h3>Methods</h3><div>We first performed multiple linear regression analyses to assess the association between energy-adjusted intake of fructose from different sources (total, fruit, fruit juice and sugar-sweetened beverages) and blood pressure (24-h ambulatory, 7-day ambulatory, and office) using data from The Maastricht Study, a large population-based cohort (n = 5,426–6,471). Next, we conducted a randomized crossover trial in which healthy individuals (n = 21) were exposed to a fixed amount of fructose (20g) from different matrices (apple, mashed apple, apple juice, and fructose dissolved in water), and measured the serum fructose and blood pressure response.</div></div><div><h3>Results</h3><div>The intake of fructose from sugar-sweetened beverages, but not from fruits or fruit juice, was associated with higher ambulatory 7-day mean blood pressure, higher office blood pressure, and greater risk of hypertension (OR: 1.29, 95%CI 1.12; 1.50 per 10g fructose). In the crossover study, pure fructose intake yielded the greatest serum fructose excursions (p < 0.05 for all comparisons). The systolic blood pressure response was higher after pure fructose compared to the other matrices (+1.8 mmHg, 95%CI 0.02; 3.5).</div></div><div><h3>Conclusions</h3><div>Here, we provide epidemiological and experimental evidence that highlights the relevance of the food matrix on fructose dynamics and blood pressure, independent of the caloric value of fructose.</div></div><div><h3>Registration</h3><div><span><span>https://onderzoekmetmensen.nl/en/trial/53397</span><svg><path></path></svg></span>; Unique identifier: NL-OMON53397.</div></div>","PeriodicalId":10517,"journal":{"name":"Clinical nutrition","volume":"55 ","pages":"Pages 134-140"},"PeriodicalIF":7.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145470672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01DOI: 10.1016/j.clnu.2025.10.020
Lucia Kerkhof, Ronald P. Mensink, Jogchum Plat, Kevin M.R. Nijssen, Peter J. Joris
Background and aims
Reduced brain vascular function contributes to age-related cognitive decline. While peanut consumption may improve cognitive performance, the underlying mechanisms remain unclear. This study aimed to investigate the longer-term effects of skin-roasted peanut consumption on brain vascular function and cognitive performance in older adults.
Methods
In a randomized, single-blind, controlled crossover trial, 31 healthy individuals (age [mean ± SD]: 67 ± 4 years; BMI: 26.7 ± 3.3 kg/m2) consumed 60 g/day of unsalted, skin-roasted peanuts or no peanuts (control) for 16 weeks, separated by an 8-week washout. During follow-up, brain vascular function was assessed by quantifying global cerebral blood flow (CBF) using arterial spin labeling magnetic resonance imaging, which was the primary outcome. Cognitive performance was evaluated using the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Results
The consumption of peanuts was well-tolerated and median compliance was excellent: 100 % (interquartile range [IQR] 99–100 %). Compared with control, peanut consumption significantly increased global CBF by 3.6 % (intervention effect: 1.5 mL/100 g/min, 95 % CI [0.3, 2.6], p = 0.014) and gray matter CBF by 4.5 % (2.2 mL/100 g/min, 95 % CI [0.9, 3.6], p = 0.002). Verbal memory improved by 5.8 % during the delayed recall condition of the verbal recognition memory (VRM) task (+1.4 words correct (95 % CI [0.0, 2.7], p = 0.043). No beneficial effects were found in executive function and psychomotor speed outcomes. Systolic blood pressure (−5 mmHg; 95 % CI [-8, −2], p = 0.004) and pulse pressure (−4 mmHg; 95 % CI [-7, −1], p = 0.006) decreased during the peanut intervention.
Conclusions
Daily consumption of skin-roasted peanuts for 16 weeks improved brain vascular function in healthy older men and women. These favorable effects may underlie the observed improvements in verbal memory, highlighting a potential mechanism by which increased peanut intake beneficially affects cognitive performance.
Clinical trial registry
This trial was registered at clinicaltrial.gov as NCT05724654.
背景和目的脑血管功能的降低会导致与年龄相关的认知能力下降。虽然食用花生可能会提高认知能力,但潜在的机制尚不清楚。本研究旨在探讨皮肤烤花生食用对老年人脑血管功能和认知能力的长期影响。方法在一项随机、单盲、对照交叉试验中,31名健康个体(年龄[mean±SD]: 67±4岁;BMI: 26.7±3.3 kg/m2)连续16周食用60 g/天的无盐、皮烤花生或不食用花生(对照组),并进行8周的洗脱期。在随访期间,通过动脉自旋标记磁共振成像量化脑血流(CBF)来评估脑血管功能,这是主要结果。认知表现采用剑桥神经心理测试自动化电池(CANTAB)进行评估。结果花生耐受良好,中位依从性极好:100%(四分位间距[IQR] 99 - 100%)。与对照组相比,花生摄入显著增加了3.6%(干预效果:1.5 mL/100 g/min, 95% CI [0.3, 2.6], p = 0.014)和4.5% (2.2 mL/100 g/min, 95% CI [0.9, 3.6], p = 0.002)的脑灰质CBF。在言语识别记忆(VRM)任务的延迟回忆条件下,言语记忆提高了5.8%(+1.4个单词正确率)(95% CI [0.0, 2.7], p = 0.043)。在执行功能和精神运动速度方面没有发现有益的影响。收缩压(- 5 mmHg, 95% CI [-8, - 2], p = 0.004)和脉压(- 4 mmHg, 95% CI [-7, - 1], p = 0.006)在花生干预期间下降。结论连续16周每天食用皮烤花生可改善健康老年男女的脑血管功能。这些有利的影响可能是观察到的言语记忆改善的基础,强调了增加花生摄入量有益影响认知表现的潜在机制。临床试验注册本试验在clinicaltrial.gov注册为NCT05724654。
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In old adult patients with sarcopenia hospitalized for rehabilitation, the superior clinical benefit of a muscle-targeted formula (MTF; whey protein-based enriched with leucine and vitamin D) over an iso-caloric protein-free one was assessed through the IRIS trial (NCT03120026). The aim of this study is to further evaluate the economic benefit in the Italian context.
Methods
A cost-consequence secondary analysis was developed. Clinical inputs were evaluated over the course of the year in terms of nutrition cost, rehabilitation cost and modality of discharge (cost of staying at home vs institution) in three different payer perspectives: (1) hospital, including only nutrition and rehabilitation costs; (2) third-party payer (TPP), including also the economic consequences of patients discharged to an institution; and (3) societal perspective, including also the economic impact on families due to home assistance. For each one, the mean annual cost per patient was calculated. An estimation of the additional number of patients that could be hospitalized each year in Italy using the MTF was also computed.
Results
The MTF was less expensive in all three perspectives considered. Mean saving per patient by perspective was: hospital, € 1536; TPP, € 10,540; societal, € 14,363. Rehabilitation was faster in patients taking the MTF resulting in lower costs to manage sarcopenia, though savings were mostly driven by patients being discharged at home instead of an institution. Finally, assuming a use of the MTF ranging from 50 % to 80 %, about 495,214–792,342 bed days could be saved meaning that 10,538–18,067 additional patients may be treated every year.
Conclusions
Costs associated with the nutritional support of adult patients with sarcopenia hospitalized for rehabilitation with a MTF were inferior than an iso-caloric formula in all payer perspectives. Furthermore, LOS was shorter and more patients could be hospitalized with the same number of beds.
{"title":"Budget impact analysis of a muscle-targeted nutritional intervention for sarcopenia","authors":"Emanuele Cereda , Massimiliano Povero , Luca Castello , Riccardo Caccialanza , Lorenzo Pradelli , Mariangela Rondanelli","doi":"10.1016/j.clnu.2025.10.019","DOIUrl":"10.1016/j.clnu.2025.10.019","url":null,"abstract":"<div><h3>Background</h3><div>In old adult patients with sarcopenia hospitalized for rehabilitation, the superior clinical benefit of a muscle-targeted formula (MTF; whey protein-based enriched with leucine and vitamin D) over an iso-caloric protein-free one was assessed through the IRIS trial (NCT03120026). The aim of this study is to further evaluate the economic benefit in the Italian context.</div></div><div><h3>Methods</h3><div>A cost-consequence secondary analysis was developed. Clinical inputs were evaluated over the course of the year in terms of nutrition cost, rehabilitation cost and modality of discharge (cost of staying at home vs institution) in three different payer perspectives: (1) hospital, including only nutrition and rehabilitation costs; (2) third-party payer (TPP), including also the economic consequences of patients discharged to an institution; and (3) societal perspective, including also the economic impact on families due to home assistance. For each one, the mean annual cost per patient was calculated. An estimation of the additional number of patients that could be hospitalized each year in Italy using the MTF was also computed.</div></div><div><h3>Results</h3><div>The MTF was less expensive in all three perspectives considered. Mean saving per patient by perspective was: hospital, € 1536; TPP, € 10,540; societal, € 14,363. Rehabilitation was faster in patients taking the MTF resulting in lower costs to manage sarcopenia, though savings were mostly driven by patients being discharged at home instead of an institution. Finally, assuming a use of the MTF ranging from 50 % to 80 %, about 495,214–792,342 bed days could be saved meaning that 10,538–18,067 additional patients may be treated every year.</div></div><div><h3>Conclusions</h3><div>Costs associated with the nutritional support of adult patients with sarcopenia hospitalized for rehabilitation with a MTF were inferior than an iso-caloric formula in all payer perspectives. Furthermore, LOS was shorter and more patients could be hospitalized with the same number of beds.</div></div>","PeriodicalId":10517,"journal":{"name":"Clinical nutrition","volume":"55 ","pages":"Pages 162-169"},"PeriodicalIF":7.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145475505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}