Ultrasound Cut-Off Values for Rectus Femoris for Detecting Sarcopenia in Patients with Nutritional Risk.

BACKGROUND: A nationwide, prospective, multicenter, cohort study (the Disease-Related caloric-protein malnutrition EChOgraphy (DRECO) study) was designed to assess the usefulness of ultrasound of the rectus femoris for detecting sarcopenia in hospitalized patients at risk of malnutrition and to define cut-off values of ultrasound measures. METHODS: Patients at risk of malnutrition according to the Malnutrition Universal Screening Tool (MUST) underwent handgrip dynamometry, bioelectrical impedance analysis (BIA), a Timed Up and Go (TUG) test, and rectus femoris ultrasound studies. European Working Group on Sarcopenia in Older People (EWGSOP2) criteria were used to define categories of sarcopenia (at risk, probable, confirmed, severe). Receiver operating characteristic (ROC) and area under the curve (AUC) analyses were used to determine the optimal diagnostic sensitivity, specificity, and predictive values of cut-off points of the ultrasound measures for the detection of risk of sarcopenia and probable, confirmed, and severe sarcopenia. RESULTS: A total of 1000 subjects were included and 991 of them (58.9% men, mean age 58.5 years) were evaluated. Risk of sarcopenia was detected in 9.6% patients, probable sarcopenia in 14%, confirmed sarcopenia in 9.7%, and severe sarcopenia in 3.9%, with significant differences in the distribution of groups between men and women (p < 0.0001). The cross-sectional area (CSA) of the rectus femoris showed a significantly positive correlation with body cell mass of BIA and handgrip strength, and a significant negative correlation with TUG. Cut-off values were similar within each category of sarcopenia, ranging between 2.40 cm2 and 3.66 cm2 for CSA, 32.57 mm and 40.21 mm for the X-axis, and 7.85 mm and 10.4 mm for the Y-axis. In general, these cut-off values showed high sensitivities, particularly for the categories of confirmed and severe sarcopenia, with male patients also showing better sensitivities than women. CONCLUSIONS: Sarcopenia in hospitalized patients at risk of malnutrition was high. Cut-off values for the better sensitivities and specificities of ultrasound measures of the rectus femoris are established. The use of ultrasound of the rectus femoris could be used for the prediction of sarcopenia and be useful to integrate nutritional study into real clinical practice.

Pharmaceutical targeting of the cannabinoid type 1 receptor impacts the crosstalk between immune cells and islets to reduce insulitis in humans.

AIMS/HYPOTHESIS: Insulitis, a hallmark of inflammation preceding autoimmune type 1 diabetes, leads to the eventual loss of functional beta cells. However, functional beta cells can persist even in the face of continuous insulitis. Despite advances in immunosuppressive treatments, maintaining functional beta cells to prevent insulitis progression and hyperglycaemia remains a challenge. The cannabinoid type 1 receptor (CB1R), present in immune cells and beta cells, regulates inflammation and beta cell function. Here, we pioneer an ex vivo model mirroring human insulitis to investigate the role of CB1R in this process. METHODS: CD4+ T lymphocytes were isolated from peripheral blood mononuclear cells (PBMCs) from male and female individuals at the onset of type 1 diabetes and from non-diabetic individuals, RNA was extracted and mRNA expression was analysed by real-time PCR. Single beta cell expression from donors with type 1 diabetes was obtained from data mining. Patient-derived human islets from male and female cadaveric donors were 3D-cultured in solubilised extracellular matrix gel in co-culture with the same donor PBMCs, and incubated with cytokines (IL-1ß, TNF-α, IFN-γ) for 24-48 h in the presence of vehicle or increasing concentrations of the CB1R blocker JD-5037. Expression of CNR1 (encoding for CB1R) was ablated using CRISPR/Cas9 technology. Viability, intracellular stress and signalling were assayed by live-cell probing and real-time PCR. The islet function measured as glucose-stimulated insulin secretion was determined in a perifusion system. Infiltration of immune cells into the islets was monitored by microscopy. Non-obese diabetic mice aged 7 weeks were treated for 1 week with JD-5037, then euthanised. Profiling of immune cells infiltrated in the islets was performed by flow cytometry. RESULTS: CNR1 expression was upregulated in circulating CD4+ T cells from individuals at type 1 diabetes onset (6.9-fold higher vs healthy individuals) and in sorted islet beta cells from donors with type 1 diabetes (3.6-fold higher vs healthy counterparts). The peripherally restricted CB1R inverse agonist JD-5037 arrested the initiation of insulitis in humans and mice. Mechanistically, CB1R blockade prevented islet NO production and ameliorated the ATF6 arm of the unfolded protein response. Consequently, cyto/chemokine expression decreased in human islets, leading to sustained islet cell viability and function. CONCLUSIONS/INTERPRETATION: These results suggest that CB1R could be an interesting target for type 1 diabetes while highlighting the regulatory mechanisms of insulitis. Moreover, these findings may apply to type 2 diabetes where islet inflammation is also a pathophysiological factor. DATA AVAILABILITY: Transcriptomic analysis of sorted human beta cells are from Gene Expression Omnibus database, accession no. GSE121863, available at https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSM3448161 .

AI-Assisted Body Composition Assessment Using CT Imaging in Colorectal Cancer Patients: Predictive Capacity for Sarcopenia and Malnutrition Diagnosis.

(1) Background: The assessment of muscle mass is crucial in the nutritional evaluation of patients with colorectal cancer (CRC), as decreased muscle mass is linked to increased complications and poorer prognosis. This study aims to evaluate the utility of AI-assisted L3 CT for assessing body composition and determining low muscle mass using both the Global Leadership Initiative on Malnutrition (GLIM) criteria for malnutrition and the European Working Group on Sarcopenia in Older People (EWGSOP2) criteria for sarcopenia in CRC patients prior to surgery. Additionally, we aim to establish cutoff points for muscle mass in men and women and propose their application in these diagnostic frameworks. (2) Methods: This retrospective observational study included CRC patients assessed by the Endocrinology and Nutrition services of the Regional University Hospitals of Malaga, Virgen de la Victoria of Malaga, and Vall d'Hebrón of Barcelona from October 2018 to July 2023. A morphofunctional assessment, including anthropometry, bioimpedance analysis (BIA), and handgrip strength, was conducted to apply the GLIM criteria for malnutrition and the EWGSOP2 criteria for sarcopenia. Body composition evaluation was performed through AI-assisted analysis of CT images at the L3 level. ROC analysis was used to determine the predictive capacity of variables derived from the CT analysis regarding the diagnosis of low muscle mass and to describe cutoff points. (3) Results: A total of 586 patients were enrolled, with a mean age of 68.4 ± 10.2 years. Using the GLIM criteria, 245 patients (41.8%) were diagnosed with malnutrition. Applying the EWGSOP2 criteria, 56 patients (9.6%) were diagnosed with sarcopenia. ROC curve analysis for the skeletal muscle index (SMI) showed a strong discriminative capacity of muscle area to detect low fat-free mass index (FFMI) (AUC = 0.82, 95% CI 0.77-0.87, p < 0.001). The identified SMI cutoff for diagnosing low FFMI was 32.75 cm2/m2 (Sn 77%, Sp 64.3%; AUC = 0.79, 95% CI 0.70-0.87, p < 0.001) in women, and 39.9 cm2/m2 (Sn 77%, Sp 72.7%; AUC = 0.85, 95% CI 0.80-0.90, p < 0.001) in men. Additionally, skeletal muscle area (SMA) showed good discriminative capacity for detecting low appendicular skeletal muscle mass (ASMM) (AUC = 0.71, 95% CI 0.65-0.76, p < 0.001). The identified SMA cutoff points for diagnosing low ASMM were 83.2 cm2 (Sn 76.7%, Sp 55.3%; AUC = 0.77, 95% CI 0.69-0.84, p < 0.001) in women and 112.6 cm2 (Sn 82.3%, Sp 58.6%; AUC = 0.79, 95% CI 0.74-0.85, p < 0.001) in men. (4) Conclusions: AI-assisted body composition assessment using CT is a valuable tool in the morphofunctional evaluation of patients with colorectal cancer prior to surgery. CT provides quantitative data on muscle mass for the application of the GLIM criteria for malnutrition and the EWGSOP2 criteria for sarcopenia, with specific cutoff points established for diagnostic use.

Modulation of miR-29a and miR-29b Expression and Their Target Genes Related to Inflammation and Renal Fibrosis by an Oral Nutritional Supplement with Probiotics in Malnourished Hemodialysis Patients.

Malnutrition is prevalent in patients with chronic kidney disease (CKD), especially those on hemodialysis. Recently, our group described that a new oral nutritional supplement (ONS), specifically designed for malnourished (or at risk) hemodialysis patients with a "similar to the Mediterranean diet" pattern, improved caloric-protein intake, nutritional status and biomarkers of inflammation and oxidation. Our aim in this study was to evaluate whether the new ONS, associated with probiotics or not, may produce changes in miRNA's expression and its target genes in malnourished hemodialysis patients, compared to individualized diet recommendations. We performed a randomized, multicenter, parallel-group trial in malnourished hemodialysis patients with three groups (1: control (C) individualized diet (n = 11); 2: oral nutritional supplement (ONS) + placebo (ONS-PL) (n = 10); and 3: ONS + probiotics (ONS-PR) (n = 10)); the trial was open regarding the intake of ONS or individualized diet recommendations but double-blinded for the intake of probiotics. MiRNAs and gene expression levels were analyzed by RT-qPCR at baseline and after 3 and 6 months. We observed that the expression of miR-29a and miR-29b increased significantly in patients with ONS-PR at 3 months in comparison with baseline, stabilizing at the sixth month. Moreover, we observed differences between studied groups, where miR-29b expression levels were elevated in patients receiving ONS-PR compared to the control group in the third month. Regarding the gene expression levels, we observed a decrease in the ONS-PR group compared to the control group in the third month for RUNX2 and TNFα. TGFB1 expression was decreased in the ONS-PR group compared to baseline in the third month. PTEN gene expression was significantly elevated in the ONS-PR group at 3 months in comparison with baseline. LEPTIN expression was significantly increased in the ONS-PL group at the 3-month intervention compared to baseline. The new oral nutritional supplement associated with probiotics increases the expression levels of miR-29a and miR-29b after 3 months of intervention, modifying the expression of target genes with anti-inflammatory and anti-fibrotic actions. This study highlights the potential benefit of this oral nutritional supplement, especially associated with probiotics, in malnourished patients with chronic renal disease on hemodialysis.

Au@16-pH-16/miR-21 mimic nanosystem: An efficient treatment for obesity through browning and thermogenesis induction.

Despite the abundance of registered clinical trials worldwide, the availability of effective drugs for obesity treatment is limited due to their associated side effects. Thus, there is growing interest in therapies that stimulate energy expenditure in white adipose tissue. Recently, we demonstrated that the delivery of a miR-21 mimic using JetPEI effectively inhibits weight gain in an obese mouse model by promoting metabolism, browning, and thermogenesis, suggesting the potential of miR-21 mimic as a treatment for obesity. Despite these promising results, the implementation of more advanced delivery system techniques for miR-21 mimic would greatly enhance the advancement of safe and efficient treatment approaches for individuals with obesity in the future. Our objective is to explore whether a new delivery system based on gold nanoparticles and Gemini surfactants (Au@16-ph-16) can replicate the favorable effects of the miR-21 mimic on weight gain, browning, and thermogenesis. We found that dosages as low as 0.2 µg miR-21 mimic /animal significantly inhibited weight gain and induced browning and thermogenic parameters. This was evidenced by the upregulation of specific genes and proteins associated with these processes, as well as the biogenesis of beige adipocytes and mitochondria. Significant increases in miR-21 levels were observed in adipose tissue but not in other tissue types. Our data indicates that Au@16-ph-16 could serve as an effective delivery system for miRNA mimics, suggesting its potential suitability for the development of future clinical treatments against obesity.

Standards for the Use of Enteral Nutrition in Patients with Diabetes or Stress Hyperglycaemia: Expert Consensus.

(1) Background: Hyperglycaemia that occurs during enteral nutrition (EN) should be prevented and treated appropriately since it can have important consequences for morbidity and mortality. However, there are few quality studies in the literature regarding the management of EN in this situation. The objective of this project was to attempt to respond, through a panel of experts, to those clinical problems regarding EN in patients with diabetes or stress hyperglycaemia (hereinafter referred to only as hyperglycaemia) for which we do not have conclusive scientific evidence; (2) Methods: The RAND/UCLA Appropriateness Method, a modified Delphi panel method, was applied. A panel of experts made up of 10 clinical nutrition specialists was formed, and they scored on the appropriateness of EN in hyperglycaemia, doing so in two rounds. A total of 2992 clinical scenarios were examined, which were stratified into five chapters: type of formula used, method of administration, infusion site, treatment of diabetes, and gastrointestinal complications. (3) Results: consensus was detected in 36.4% of the clinical scenarios presented, of which 23.7% were deemed appropriate scenarios, while 12.7% were deemed inappropriate. The remaining 63.6% of the scenarios were classified as uncertain; (4) Conclusions: The recommendations extracted will be useful for improving the clinical management of these patients. However, there are still many uncertain scenarios reflecting that the criteria for the management of EN in hyperglycaemia are not completely standardised. More studies are required to provide quality recommendations in this area.

Protocol for a prospective cohort study on the feasibility of application of nutritional ultrasound in the diagnosis and follow-up of patients with nutritional risk at hospital discharge: study on body composition and function (DRECO).

INTRODUCTION: Nutritional ultrasound (US) is an emerging technique in clinical nutrition for the morphological and structural study of muscle mass. Currently, all definitions of malnutrition include the measurement of muscle mass; however, there is no single way to assess it. It is necessary to develop new techniques to identify muscle involvement in malnutrition that are valid, standardised, reliable, accurate and profitable. OBJECTIVE: To value the new muscle US techniques aimed to measure muscle and functional status, to make a more accurate diagnosis and a better prediction of complications and morbidity and mortality in patients at nutritional risk. PRIMARY OUTCOME: to assess the feasibility of US or muscle US techniques in both nutritional diagnosis and follow-up in a nutritional intervention programme. METHODS AND ANALYSIS: Disease-Related caloric-protein malnutrition EChOgraphy (DRECO) is a prospective, multicentre (25 Spanish hospitals), uncontrolled clinical study in standard clinical practice to value the usefulness of nutritional US (muscle US) in the nutritional diagnosis and follow-up, over 3-6 months, after standard nutritional clinical practice intervention and physical activity, to control their disease-related malnutrition. 1000 patients are expected to be included in. DISCUSSION: This study will standardise nutritional US measures. It will validate and define specific cut-off values for nutritional US and correlate it with already well-known nutritional tools such as Subjective Global Assessment or Global Leadership Initiative on Malnutrition criteria. Thus, muscle US will become not only a tool to diagnose malnutrition, but it will also be integrated in the daily practice to evaluate nutritional interventions. ETHICS AND DISSEMINATION: All DRECO study materials have been approved by each of the IRB/IEC of all the sites enrolled (either approval of the own IRB/IEC or validating the approval of the IRB/IEC of another hospital). The study has been registered with ClinicalTrials.gov, on 27 June 2022. The results from this study will be presented at scientific conferences and in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT05433831.

MiR-221-3p/222-3p Cluster Expression in Human Adipose Tissue Is Related to Obesity and Type 2 Diabetes.

The progression of obesity and type 2 diabetes (T2D) is intricately linked with adipose tissue (AT) angiogenesis. Despite an established network of microRNAs (miRNAs) regulating AT function, the specific role of angiogenic miRNAs remains less understood. The miR-221/222 cluster has recently emerged as being associated with antiangiogenic activity. However, no studies have explored its role in human AT amidst the concurrent development of obesity and T2D. Therefore, this study aims to investigate the association between the miR-221-3p/222-3p cluster in human AT and its regulatory network with obesity and T2D. MiR-221-3p/222-3p and their target gene (TG) expression levels were quantified through qPCR in visceral (VAT) and subcutaneous (SAT) AT from patients (n = 33) categorized based on BMI as normoweight (NW) and obese (OB) and by glycemic status as normoglycemic (NG) and type 2 diabetic (T2D) subjects. In silico analyses of miR-221-3p/222-3p and their TGs were conducted to identify pertinent signaling pathways. The results of a multivariate analysis, considering the simultaneous expression of miR-221-3p and miR-222-3p as dependent variables, revealed statistically significant distinctions when accounting for variables such as tissue depot, obesity, sex, and T2D as independent factors. Furthermore, both miRNAs and their TGs exhibited differential expression patterns based on obesity severity, glycemic status, sex, and type of AT depot. Our in silico analysis indicated that miR-221-3p/222-3p cluster TGs predominantly participate in angiogenesis, WNT signaling, and apoptosis pathways. In conclusion, these findings underscore a promising avenue for future research, emphasizing the miR-221-3p/222-3p cluster and its associated regulatory networks as potential targets for addressing obesity and related metabolic disorders.

Expert design thinking workshops to analyze users' perceived applicability of NUTRI-ONCOCARE algorithm to prevent and treat malnutrition in cancer patients under routine clinical practice conditions in Spain: the ALLIANCE study.

PURPOSE: NUTRI-ONCOCARE algorithm has been developed to identify and treat patients with solid tumors who are at risk of malnutrition. The present study is aimed at analyzing users' opinion about this new tool and at assessing whether it is perceived as useful to achieve the behavioral change required for a successful integration of nutritional assessment into routine cancer care. METHODS: Design thinking Double Diamond process was applied. A multidisciplinary team composed of ten potential end-users (four oncologists, three endocrinologists, one nutritionist, and two hospital pharmacists) participated in three different workshops aiming to analyze the different tasks included within the NUTRI-ONCOCARE algorithm. RESULTS: Users agreed on the need to perform nutritional assessment around cancer diagnosis and through the course of the disease using standardized tools included in hospital nutritional protocols and involving healthcare professionals with nutrition expertise. Nutritional evaluation and intervention should be individual and comprehensive, considering not only nutritional parameters but also patients' functional status. According to participants' opinion, the implementation of nutritional screening in routine clinical practice is limited by the lack of time and staff to conduct nutritional assessments, the low level of nutrition expert participation, and the poor support provided by hospital managers, which are often unaware of nutrition's impact in cancer care. CONCLUSIONS: Experts recognized the importance of considering nutritional status in cancer patients and identified the opportunity provided by the NUTRI-ONCOCARE algorithm for this purpose, as it meets main requirements for being used routinely in clinical practice.

Experience With Elexacaftor/Tezacaftor/Ivacaftor in Patients With Cystic Fibrosis and Advanced Disease

Introduction: Elexacaftor/tezacaftor/ivacaftor (ETI) was used through the early access programme in Spain from December 2019 in cystic fibrosis (CF) patients with homozygous or heterozygous F508del mutation with advanced lung disease. Methodology: Multicentre, ambispective, observational, study in which 114 patients in follow-up in 16 national CF units were recruited. Clinical data, functional tests, nutritional parameters, quality of life questionnaires, microbiological isolates, number of exacerbations, antibiotic treatments and side effects were collected. The study also compared patients with homozygous and heterozygous F508del mutations. Results: Of the 114 patients, 85 (74.6%) were heterozygous for F508del mutation, and the mean age was 32.2±9.96 years. After 30 months of treatment, lung function measured by FEV1% showed improvement from 37.5 to 48.6 (p<0.001), BMI increased from 20.5 to 22.3 (p<0.001), and all isolated microorganisms decreased significantly. The total number of exacerbations was also significantly reduced from 3.9 (±2.9) to 0.9 (±1.1) (p<0.001). All items in the CFQ-R questionnaire showed improvement, except for the digestive domain. Oxygen therapy use decreased by 40%, and only 20% of patients referred for lung transplantation remained on the active transplant list. ETI was well-tolerated, with only 4 patients discontinuing treatment due to hypertransaminemia. Conclusions: ETI decreases the number of exacerbations, increases lung function and nutritional parameters, decrease in all isolated microorganisms, for 30 months of treatment. There is an improvement in the CFQ-R questionnaire score except for the digestive item. It is a safe and well-tolerated drug. (AU)

Management of thyroid dysfunction and thyroid nodules in the ageing patient.

Thyroid dysfunction is a common endocrine disorder in the general population, with a reported prevalence of 10-15%. However, this rate is even higher in older adults, with an estimated prevalence of ≈25% in some populations. Since elderly patients usually present more comorbidities than younger individuals, thyroid dysfunction may carry a synergistic negative health impact, mainly due to increased cardiovascular disease risk. Moreover, thyroid dysfunction in the elderly can be more difficult to diagnose due to its subtle or even asymptomatic clinical presentation, and the interpretation of thyroid function tests may be affected by drugs that interfere with thyroid function or by the coexistence of several diseases. On the other hand, thyroid nodules are also a prevalent condition in older adults, and its incidence increases with age. The assessment and management of thyroid nodules in the ageing patient should take into account several factors, as risk stratification, thyroid cancer biology, patient´s overall health, comorbidities, treatment preferences, and goals of care. In this review article, we summarize the current knowledge on the pathophysiology, diagnosis, and therapeutic management of thyroid dysfunction in elderly patients and we also review how to identify and manage thyroid nodules in this population.

Experience With Elexacaftor/Tezacaftor/Ivacaftor in Patients With Cystic Fibrosis and Advanced Disease.

INTRODUCTION: Elexacaftor/tezacaftor/ivacaftor (ETI) was used through the early access programme in Spain from December 2019 in cystic fibrosis (CF) patients with homozygous or heterozygous F508del mutation with advanced lung disease. METHODOLOGY: Multicentre, ambispective, observational, study in which 114 patients in follow-up in 16 national CF units were recruited. Clinical data, functional tests, nutritional parameters, quality of life questionnaires, microbiological isolates, number of exacerbations, antibiotic treatments and side effects were collected. The study also compared patients with homozygous and heterozygous F508del mutations. RESULTS: Of the 114 patients, 85 (74.6%) were heterozygous for F508del mutation, and the mean age was 32.2±9.96 years. After 30 months of treatment, lung function measured by FEV1% showed improvement from 37.5 to 48.6 (p<0.001), BMI increased from 20.5 to 22.3 (p<0.001), and all isolated microorganisms decreased significantly. The total number of exacerbations was also significantly reduced from 3.9 (±2.9) to 0.9 (±1.1) (p<0.001). All items in the CFQ-R questionnaire showed improvement, except for the digestive domain. Oxygen therapy use decreased by 40%, and only 20% of patients referred for lung transplantation remained on the active transplant list. ETI was well-tolerated, with only 4 patients discontinuing treatment due to hypertransaminemia. CONCLUSIONS: ETI decreases the number of exacerbations, increases lung function and nutritional parameters, decrease in all isolated microorganisms, for 30 months of treatment. There is an improvement in the CFQ-R questionnaire score except for the digestive item. It is a safe and well-tolerated drug.

Rich oleocanthal and oleacein extra virgin olive oil and inflammatory and antioxidant status in people with obesity and prediabetes. The APRIL study: A randomised, controlled crossover study.

BACKGROUND: Oleocanthal and oleacein are olive oil phenolic compounds with well known anti-inflammatory and anti-oxidant properties. The main evidence, however, is provided by experimental studies. Few human studies have examined the health benefits of olive oils rich in these biophenols. Our aim was to assess the health properties of rich oleocanthal and oleacein extra virgin olive oil (EVOO), compared to those of common olive oil (OO), in people with prediabetes and obesity. METHODS: Randomised, double-blind, crossover trial done in people aged 40-65 years with obesity (BMI 30-40 kg/m2) and prediabetes (HbA1c 5.7-6.4%). The intervention consisted in substituting for 1 month the oil used for food, both raw and cooked, by EVOO or OO. No changes in diet or physical activity were recommended. The primary outcome was the inflammatory status. Secondary outcomes were the oxidative status, body weight, glucose handling and lipid profile. An ANCOVA model adjusted for age, sex and treatment administration sequence was used for the statistical analysis. RESULTS: A total of 91 patients were enrolled (33 men and 58 women) and finished the trial. A decrease in interferon-γ was observed after EVOO treatment, reaching inter-treatment differences (P = 0.041). Total antioxidant status increased and lipid and organic peroxides decreased after EVOO treatment, the changes reaching significance compared to OO treatment (P < 0.05). Decreases in weight, BMI and blood glucose (p < 0.05) were found after treatment with EVOO and not with OO. CONCLUSIONS: Treatment with EVOO rich in oleocanthal and oleacein differentially improved oxidative and inflammatory status in people with obesity and prediabetes.

Compliance with a high-protein and energy-dense oral nutritional supplement in patients with disease-related malnutrition: a randomized open-label crossover trial.

Introduction: Patient compliance with oral nutritional supplements (ONS) is not optimal for meeting energy and nutritional requirements in a high proportion of patients with disease-related malnutrition (DRM). Energy density or prescribed volume of ONS may impact compliance. Methods: A randomized, open-label crossover trial was conducted in outpatients with DRM to compare compliance with a high energy-dense ONS (edONS, 2.4 kcal/mL) and a reference ONS (heONS, 2.0 kcal/mL; NCT05609006). Patients were randomly assigned to two 8-week treatment sequences of four-weeks periods: edONS + heONS (sequence A) or heONS + edONS (sequence B). Patients daily reported the amount of product left over gastrointestinal tolerance and satisfaction with ONS. A non-inferiority analysis was performed to compare the compliance rate (percentage of consumed energy over the prescribed) for each period and sequence. Results: Fifty-three patients were assigned to sequence A and 50 to sequence B (55.7 ± 13.9 years, 37.0% female, 67.1% oncology patients). In sequence A, the compliance rates were 88.6% ± 14.3% vs. 84.1 ± 21.8% (p = 0.183), while in sequence B, they were 78.9% ± 23.8% vs. 84.4% ± 21.4% (p < 0.01). In both sequences, the lower range of the confidence interval for compliance with edONS was greater than the non-inferiority threshold (for sequence A ΔCompA was 4.5% [95% CI, -2.0% to 10.0%], and for sequence, B ΔCompB was 5.6% [95% CI, -3.0% to 14.0%]). The total discarded cost for each ONS was higher for heONS than edONS, being the difference statistically significant in sequence B. BMI increased slightly and not significantly in both sequences, and the percentage of patients with severe malnutrition was reduced. The frequency of gastrointestinal symptoms was low for both sequences, and satisfaction with ONS was slightly higher for edONS. Conclusion: Our findings highlight that edONS was non-inferior to heONS in terms of consumed energy over the prescribed, with a lower amount of edONS discarded, which suggests a higher efficiency of edONS.

Global Subjective Assessment and Mini Nutritional Assessment Short Form Better Predict Mortality Than GLIM Malnutrition Criteria in Elderly Patients with Hip Fracture.

The objective of our study is to determine the prevalence of malnutrition in elderly patients with fragility hip fractures through different diagnostic tools and to determine which nutritional assessment tool better predicts mortality. METHODS: This is a prospective study in patients over 65 years of age hospitalized with a diagnosis of hip fracture. A nutritional assessment was performed using several tools: the Mini Nutritional Assessment Short Form (MNA-SF), the Subjective Global Assessment (SGA), and the GLIM criteria. For the definition of low muscle mass, four different methods were used: hand grip strength (HGS), calf circumference (CC), anthropometry, and bioelectrical impedance (BIA). Mortality was registered at three, six and twelve months. RESULTS: 300 patients were included, 79.3% female, mean age 82.9 ± 7.1 years. The MNA-SF found 42% at risk of malnutrition, and 37.3% malnourished. Using SGA, there were 44% with moderate malnutrition, and 21.7% with severe malnutrition. In application of the GLIM criteria, 84.3%, 47%, 46%, and 72.7% of patients were malnourished when HGS, anthropometry, BIA, and CC were used, respectively. Mortality was 10%, 16.3% and 22% at 3, 6 and 12 months, respectively. In malnourished patients according to MNA-SF, mortality was 5.7 times greater [95%CI 1.3-25.4; p = 0.022] at 6 months and 3.8 times greater [95%CI 1.3-11.6; p = 0.018] at 12 months. In malnourished patients according to SGA, mortality was 3.6 times greater [95%CI 1.02-13.04; p = 0.047] at 3 months, 3.4 times greater [95%CI 1.3-8.6; p = 0.012] at 6 months and 3 times greater [95%CI 1.35-6.7; p = 0.007] at 12 months. CONCLUSION: The prevalence of malnutrition in patients admitted for fragility hip fracture is high. The SGA and MNA-SF are postulated as adequate tools to diagnose malnutrition in these patients, with predictive value for mortality at three, six, and twelve months.

Expert Consensus on Morphofunctional Assessment in Disease-Related Malnutrition. Grade Review and Delphi Study.

Disease-related malnutrition (DRM) affects approximately a third of hospitalized patients and is associated with an increased risk of morbimortality. However, DRM is often underdiagnosed and undertreated. Our aim is to evaluate the prognostic value of morphofunctional tools and tests for nutritional assessment in clinical practice. A systematic literature review was conducted to identify studies relating to the morphofunctional assessment of nutritional status and mortality or complications. Evidence was evaluated using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) method. Twelve GRADE recommendations were made and divided into seven topics: food intake and nutrient assimilation, anthropometry, biochemical analysis, hand grip strength, phase angle, muscle imaging, and functional status and quality of life. From these recommendations, 37 statements were developed and scored in a two-survey Delphi method by 183 experts. A consensus was reached on accepting 26/37 statements. Surveys had high internal consistency and high inter-rater reliability. In conclusion, evidence-based recommendations were made on the prognostic value of morphofunctional assessment tools and tests to assess malnutrition, most of which were found to be feasible in routine clinical practice, according to expert opinions.

Effect on nutritional status and biomarkers of inflammation and oxidation of an oral nutritional supplement (with or without probiotics) in malnourished hemodialysis patients. A multicenter randomized clinical trial "Renacare Trial".

Background: Malnutrition in patients undergoing hemodialysis is frequent and associated with a reduction in muscular mass and strength, with an increment in biomarkers of inflammation and oxidation. Materials and methods: Randomized, multicenter, parallel-group trial in malnourished hemodialysis patients with three groups [(1) control (C) individualized diet, (2) oral nutritional supplement-ONS- + placebo-SU- PL-, and (3) ONS + probiotics-SU-PR]; the trial was open regarding the intake of ONS or individualized diet recommendations, but double-blind for the intake of probiotics. We obtained, at baseline and after 3 and 6 months, anthropometric measurements, handgrip strength, bioelectrical impedance analysis (BIA), dietary records, and routine biochemical parameters. Inflammation and oxidation were determined using ELISA techniques (Versamax and ProcartaPlex multiplex Immunoassay). Results were analyzed by intention to treat. Results: A total of 31 patients (11 corresponding to group C, 10 to SU-PL, and 10 to SU-PR) completed the 6-months trial. The two groups that took supplements significantly increased their protein calorie, fat (total and n-3), and fiber intake. Weight and fat-free mass (FFM) also increased significantly in the groups on supplements, both at 3 and 6 months, and dynamometry did so in the SU-PL group. At month 3, prealbumin and vitamin D were significantly increased in the SU-TOT (SU-PL + SU-PR) group. No changes were observed regarding levels of phosphorus and potassium in any of the groups. Urea increased significantly at 6 months in the SU-PL group. There were significant changes in some inflammation biomarkers in the groups on supplements during the intervention (brain-derived neurotrophic factor, bone morphogenetic protein-2, MCP-1, IL-1-beta, IL-10, IL-4, and IL-8). The total antioxidant capacity (TAC) increased significantly in the supplemented patients, with no significant changes observed in isoprostanes. Conclusion: The specific ONS improved protein-calorie intake, nutritional status (mainly FFM), and some biomarkers of inflammation/oxidation. The addition of probiotics could have a synergistic effect with ONS in such biomarkers. Clinical trail registration: https://clinicaltrials.gov/ct2/show/, identifier NCT03924089.