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Introduction: Chemoradiotherapy in head and neck cancer patients has a curative intent but often deteriorates nutritional status leading to sarcopenia and cachexia. Methods: In this observational and single-centered study, a prospective evaluation of several biochemical and anthropometrical parameters, weight loss, handgrip strength, visual analogue scale of appetite, questionnaires associated with malnutrition & quality of life and body composition (obtained by Bioelectrical Impedance Vector Analysis) was performed before and after high-dose cisplatin chemotherapy combined with radiotherapy in 60 patients affected by head and neck cancer. Oral nutritional supplements were used to reach the correct number of daily calories and proteins. Results and discussion: All patients completed radiotherapy as planned and the 96,4% of them did not interrupt chemotherapy for toxicity, reaching a total dose of at least 200mg/m2. Despite a rapid deterioration of body composition during treatment, nutritional support helped patients to maintain (or in some cases improve) anthropometric parameters from the end of chemoradiotherapy to the following 3 months. Low prealbumin and albumin pre-treatment led to higher risk of toxicities with consequent reduction of cisplatin dose intensity, whereas weight at the end of the treatment seems to be an interesting predicting factor for disease free and overall survival (p=0.007; p=0.015). [ABSTRACT FROM AUTHOR]

Abstract Background Body weight loss (BWL) after gastrectomy impact on the short- and long-term outcomes. Oral nutritional supplement (ONS) has potential to prevent BWL in patients after gastrectomy. However, there is no consistent evidence supporting the beneficial effects of ONS on BWL, muscle strength and health-related quality of life (HRQoL). This study aimed to evaluate the effects of ONS formulated primarily with carbohydrate and protein on BWL, muscle strength, and HRQoL. Methods This will be a multicenter, open-label, parallel, randomized controlled trial in patients with gastric cancer who will undergo gastrectomy. A total of 120 patients who will undergo gastrectomy will be randomly assigned to the ONS group or usual care (control) group in a 1:1 ratio. The stratification factors will be the clinical stage (I or ≥ II) and surgical procedures (total gastrectomy or other procedure). In the ONS group, the patients will receive 400 kcal (400 ml)/day of ONS from postoperative day 5 to 7, and the intervention will continue postoperatively for 8 weeks. The control group patients will be given a regular diet. The primary outcome will be the percentage of BWL (%BWL) from baseline to 8 weeks postoperatively. The secondary outcomes will be muscle strength (handgrip strength), HRQoL (EORTC QLQ-C30, QLQ-OG25, EQ-5D-5L), nutritional status (hemoglobin, lymphocyte count, albumin), and dietary intake. All analyses will be performed on an intention-to-treat basis. Discussion This study will provide evidence showing whether or not ONS with simple nutritional ingredients can improve patient adherence and HRQoL by reducing BWL after gastrectomy. If supported by the study results, nutritional support with simple nutrients will be recommended to patients after gastrectomy for gastric cancer. Trial registration jRCTs051230012; Japan Registry of Clinical Trails. Registered on Apr. 13, 2023.

Abstract Background Malnutrition of older individuals, leads to significant functional decline, reducing their quality of life. Lifestyle interventions; dietary improvements and supplementation are explored to enhance the physical function of older adults. The current study aimed to assess the impact of oral nutritional supplements (ONS) on the functional and activity levels of Sri Lankan older adults. Methods This randomized controlled trial included; an intervention group (IG) receiving 200 mL of ONS providing 247 kcal per serving, for 12 weeks and a control group (CG) receiving an equivalent volume of water. Changes in handgrip strength, knee extension strength, gait speed, functional and activity levels were assessed. Results The IG showed significant improvements in handgrip strength (43.96 ± 18.61 kg vs. 32.81 ± 17.92 kg; p

Abstract Introduction Several side effects within the patients undergoing hematopoietic stem cell transplantation (HSCT), especially ones that influence nutrition intake, can cause weight loss and malnutrition. Based on studies, oral nutritional supplement (ONS) may reinforce their nutrient intake and progress clinical outcomes. The objective of this research is to investigate the effect of oral nutrition supplements on the nutritional and clinical status of patients undergoing autologous hematopoietic stem cell transplantation. Methods After block randomization used the website www.randomization , 38 patients will be enrolled in this study, patients will be allocated to the intervention (ONS) or control groups in a 1: 1 ratio. Patients in the ONS group will receive 250 ml of standard formula (Ensure®, Abbott Nutrition) which has 14–15% protein twice a day, in the morning and bedtime snacks for 21 days. All the procedures done in the control group will be the same as the ONS group except receiving ONS. We will examine the outcomes include; weight, appetite, hand grip strength, calf circumference, mid-arm circumference, total energy intake, protein intake, carbohydrate intake, fat intake, severity of oral mucositis, rate of infection during hospitalization, graft failure, recurrence rate after transplantation, the number of days it takes for neutrophil and platelet engraftment to occur, number of readmissions after transplantation during three months, mortality rate up to three months after transplantation and the three-day food diary record; all the evaluations will be carried out in three steps; 7 days before transplant, on the 14th day after transplantation, and on the 90th day after the transplantation. Discussion These patients’ weight loss and malnourishment are significant concerns. The use of ONS in patients receiving HSCT has not been the subject of any research. Trial registration This clinical trial was registered in Iranian Registry of Clinical Trials ( http://www.irct.ir ) on 2022-12-09 with the code number IRCT20220208053971N2.

Oral nutritional supplements (ONS) play a key role in the therapy of cancer-cachexia, but adherence to ONS-intake remains challenging. To improve adherence, a wide variety of ONS is crucial. We compared the acceptance and adherence of a commercial liquid ONS (LS) with a newly developed, energy- and protein-rich, semisolid, fruit-gum based product (FG) in oncological patients. Forty cancer patients with indication for artificial nutritional therapy were randomly assigned to LS and FG in crossover design for 4 weeks with a 1-week washout phase in-between. Adherence to ONS was recorded with MARS-D questionnaire. Sensory properties were evaluated and safety monitoring was performed. Energy and nutrient intake, nutrition and performance status and quality of life remained stable in both groups throughout the study (all p-values for the comparison between baseline and after 9 weeks were >0.05). Taste (p=0.004), smell (p=0.025) and enjoyment (p=0.027) of the LS were rated significantly better compared to FG and a higher adherence (p=0.005) for the LS was found. Nevertheless, patients were very interested about the new alternative of ONS, so that 16 of the study participants would buy it or strive for a medical prescription. The balanced, protein-rich ONS based on fruit gum is an innovative formulation that stabilizes nutritional status and might therefore extend the options for nutritional support in cancer patients in the future. However, the sensory properties must first be further improved to increase acceptance and adherence. [ABSTRACT FROM AUTHOR]

Malnutrition may result in abnormal biochemical and hematological indices. This planned prespecified analysis investigated the effects of a specialized oral nutritional supplement (ONS) on biochemical and hematological indices in community-dwelling older adults at risk of malnutrition. In the Strengthening Health in ELDerly through nutrition (SHIELD) study, 811 older adults aged 65 years and above took part in this randomized, double-blind, placebo-controlled, multi-center study. Participants were randomly allocated to either a complete and balanced specialized ONS (each serving provides 262 kcal, 10.5 g protein, 7.75 µg vitamin D3, and 0.74 g calcium β-hydroxy-β-methylbutyrate) and dietary counselling (intervention group) or a placebo and dietary counselling (placebo group). Both groups consumed study products twice a day for 180 days. Data were collected at baseline, day 90, and day 180. Blood analysis results at follow-up visits were analyzed using repeated measures analysis of covariance with adjustments for confounders. Overall, when compared with the placebo group, the intervention group showed significantly greater urea (6.0 mmol/L vs. 5.4 mmol/L, p < 0.001), urea to creatinine ratio (4.39 vs. 4.26, p < 0.001), prealbumin (24.9 mg/dL vs. 24.0 mg/dL, p < 0.001), vitamin B12 (480.0 pmol/L vs. 420.1 pmol/L, p < 0.001), and globulin levels (26.8 g/L vs. 26.5 g/L, p = 0.032). The intervention group also had a significantly higher absolute reticulocyte count (62.0 × 103/µL vs. 58.2 × 103/µL, overall p < 0.001) and mean platelet volume (10.0 fL vs. 9.9 fL, overall p = 0.003). Furthermore, significant improvements were seen in total protein at day 90 (71.7 g/L vs. 71.1 g/L, p = 0.017) and in absolute monocyte count at day 90 (0.50 × 103/µL vs. 0.47 × 103/µL, p = 0.009) in the intervention group. In conclusion, daily consumption of a specialized ONS for six months led to significant improvements in biochemical and hematological indices in community-dwelling older adults at risk of malnutrition. [ABSTRACT FROM AUTHOR]

Background: Body weight loss (BWL) after gastrectomy impact on the short- and long-term outcomes. Oral nutritional supplement (ONS) has potential to prevent BWL in patients after gastrectomy. However, there is no consistent evidence supporting the beneficial effects of ONS on BWL, muscle strength and health-related quality of life (HRQoL). This study aimed to evaluate the effects of ONS formulated primarily with carbohydrate and protein on BWL, muscle strength, and HRQoL. Methods: This will be a multicenter, open-label, parallel, randomized controlled trial in patients with gastric cancer who will undergo gastrectomy. A total of 120 patients who will undergo gastrectomy will be randomly assigned to the ONS group or usual care (control) group in a 1:1 ratio. The stratification factors will be the clinical stage (I or ≥ II) and surgical procedures (total gastrectomy or other procedure). In the ONS group, the patients will receive 400 kcal (400 ml)/day of ONS from postoperative day 5 to 7, and the intervention will continue postoperatively for 8 weeks. The control group patients will be given a regular diet. The primary outcome will be the percentage of BWL (%BWL) from baseline to 8 weeks postoperatively. The secondary outcomes will be muscle strength (handgrip strength), HRQoL (EORTC QLQ-C30, QLQ-OG25, EQ-5D-5L), nutritional status (hemoglobin, lymphocyte count, albumin), and dietary intake. All analyses will be performed on an intention-to-treat basis. Discussion: This study will provide evidence showing whether or not ONS with simple nutritional ingredients can improve patient adherence and HRQoL by reducing BWL after gastrectomy. If supported by the study results, nutritional support with simple nutrients will be recommended to patients after gastrectomy for gastric cancer. Trial registration: jRCTs051230012; Japan Registry of Clinical Trails. Registered on Apr. 13, 2023. [ABSTRACT FROM AUTHOR]

Background: Malnutrition of older individuals, leads to significant functional decline, reducing their quality of life. Lifestyle interventions; dietary improvements and supplementation are explored to enhance the physical function of older adults. The current study aimed to assess the impact of oral nutritional supplements (ONS) on the functional and activity levels of Sri Lankan older adults. Methods: This randomized controlled trial included; an intervention group (IG) receiving 200 mL of ONS providing 247 kcal per serving, for 12 weeks and a control group (CG) receiving an equivalent volume of water. Changes in handgrip strength, knee extension strength, gait speed, functional and activity levels were assessed. Results: The IG showed significant improvements in handgrip strength (43.96 ± 18.61 kg vs. 32.81 ± 17.92 kg; p < 0.001) and knee extension strength (23.45 ± 2.29 kg vs. 16.41 ± 2.09 kg; p < 0.001) following 12 weeks compared to the CG. The IG also exhibited significant improvements in gait speed (1.31 ± 0.52 m/s vs. 0.87 ± 0.26 m/s), Barthel index score, (0.30 ± 0.47 vs. -0.18 ± 0.66), PASE score (0.52 ± 17.79 vs. -1.60 ± 21.77) and IPAQ categories. Conclusions: ONS was found to be effective in improving the functional and physical activity levels of malnourished older adults. Trial registration.: Sri Lanka Clinical Trial Registry SLCTR/2022/021. Registered on 06/10/2022. [ABSTRACT FROM AUTHOR]

Introduction: Several side effects within the patients undergoing hematopoietic stem cell transplantation (HSCT), especially ones that influence nutrition intake, can cause weight loss and malnutrition. Based on studies, oral nutritional supplement (ONS) may reinforce their nutrient intake and progress clinical outcomes. The objective of this research is to investigate the effect of oral nutrition supplements on the nutritional and clinical status of patients undergoing autologous hematopoietic stem cell transplantation. Methods: After block randomization used the website www.randomization, 38 patients will be enrolled in this study, patients will be allocated to the intervention (ONS) or control groups in a 1: 1 ratio. Patients in the ONS group will receive 250 ml of standard formula (Ensure®, Abbott Nutrition) which has 14–15% protein twice a day, in the morning and bedtime snacks for 21 days. All the procedures done in the control group will be the same as the ONS group except receiving ONS. We will examine the outcomes include; weight, appetite, hand grip strength, calf circumference, mid-arm circumference, total energy intake, protein intake, carbohydrate intake, fat intake, severity of oral mucositis, rate of infection during hospitalization, graft failure, recurrence rate after transplantation, the number of days it takes for neutrophil and platelet engraftment to occur, number of readmissions after transplantation during three months, mortality rate up to three months after transplantation and the three-day food diary record; all the evaluations will be carried out in three steps; 7 days before transplant, on the 14th day after transplantation, and on the 90th day after the transplantation. Discussion: These patients' weight loss and malnourishment are significant concerns. The use of ONS in patients receiving HSCT has not been the subject of any research. Trial registration: This clinical trial was registered in Iranian Registry of Clinical Trials (http://www.irct.ir) on 2022-12-09 with the code number IRCT20220208053971N2. Key Points: Limitations: 1. Problems related to the possibility of non-cooperation of the hospital and patients. 2. Limitations on available ONS choices and costs. Strengths: 1. The strength of this protocol is the RCT design, as the field of nutrition is limited by a lack of RCTs. 2. Our study is the first RCT on ONS in patients receiving a HSCT. [ABSTRACT FROM AUTHOR]

IntroductionChemoradiotherapy in head and neck cancer patients has a curative intent but often deteriorates nutritional status leading to sarcopenia and cachexia.MethodsIn this observational and single-centered study, a prospective evaluation of several biochemical and anthropometrical parameters, weight loss, handgrip strength, visual analogue scale of appetite, questionnaires associated with malnutrition & quality of life and body composition (obtained by Bioelectrical Impedance Vector Analysis) was performed before and after high-dose cisplatin chemotherapy combined with radiotherapy in 60 patients affected by head and neck cancer. Oral nutritional supplements were used to reach the correct number of daily calories and proteins.Results and discussionAll patients completed radiotherapy as planned and the 96,4% of them did not interrupt chemotherapy for toxicity, reaching a total dose of at least 200mg/m2. Despite a rapid deterioration of body composition during treatment, nutritional support helped patients to maintain (or in some cases improve) anthropometric parameters from the end of chemoradiotherapy to the following 3 months. Low prealbumin and albumin pre-treatment led to higher risk of toxicities with consequent reduction of cisplatin dose intensity, whereas weight at the end of the treatment seems to be an interesting predicting factor for disease free and overall survival (p=0.007; p=0.015).

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. [ABSTRACT FROM AUTHOR]

Background: Progression diets after bariatric surgery (BS) are restricted in calories and protein, and they may induce a worsening of body composition. The aim of this study was to evaluate the effect of a modified diet with an oral nutritional supplement that is hyperproteic and normocaloric over the body composition. Methods: A two-arm ambispective observational cohort study was designed. Forty-four patients who underwent sleeve gastrectomy were included in the study. Thirty patients received a progression diet with a normocaloric, hyperproteic oral nutritional supplement during the first two weeks after surgery (820 kcal, 65.5 g protein). They were compared with a historical cohort of 14 patients treated with a standard progression diet (220 kcal, 11.5 g protein). Anthropometric and body composition (using electrical bioimpedanciometry) data were analyzed before BS and 1 month after the surgery. Results: The mean age was 47.35(10.22) years; 75% were women, and the average presurgical body mass index (BMI) was 45.98(6.13) kg/m2, with no differences between both arms of intervention. One month after surgery, no differences in the percentage of excess weight loss (%PEWL) were observed between patients in the high-protein-diet group (HP) and low-protein-diet group (LP) (HP: 21.86 (12.60)%; LP: 18.10 (13.49)%; p = 0.38). A lower loss of appendicular skeletal muscle mass index was observed in the HP (HP: −5.70 (8.79)%; LP: −10.54 (6.29)%; p < 0.05) and fat-free mass index (HP: 3.86 (8.50)%; LP:−9.44 (5.75)%; p = 0.03), while a higher loss of fat mass was observed in the HP (HP: −14.22 (10.09)%; LP: −5.26 (11.08)%; p < 0.01). Conclusions: In patients undergoing gastric sleeve surgery, the addition of a normocaloric, hyperproteic formula managed to slow down the loss of muscle mass and increase the loss of fat mass with no differences on total weight loss. [ABSTRACT FROM AUTHOR]

IntroductionSeniors are vulnerable to frailty, a condition linked to falls, fractures, hospitalizations, and sarcopenia. Even with regular meals, senior daycare users are at risk for malnutrition.MethodsThis study assessed malnutrition risk in daycare users, using the web-based Mini Nutritional Assessment Form (MNA®-SF). Individuals identified as malnourished or at risk were examined for changes in nutritional status with and without oral nutritional supplementation (ONS).ResultsOf 507 subjects, 138 (27.2%) were malnourished or at risk. Discontinuation rates were 20.0% (7/35) for the ONS group and 40.0% (10/25) for the regular care (RC) group. Among 29 patients with measurable weight change after six months, 19 (ONS group) and 10 (RC group) participated. The ONS group exhibited significant increases in body weight (+1.4 ± 2.9 kg, p

Jason Shafrin,1 Kyi-Sin Than,1 Anmol Kanotra,1 Kirk W Kerr,2 Katie N Robinson,2 Michael C Willey3 1FTI Consulting, Center for Healthcare Economics and Policy, Los Angeles, CA, USA; 2Abbott Laboratories, Columbus, OH, USA; 3Department of Orthopedics & Rehabilitation, University of Iowa, Iowa City, IA, USACorrespondence: Jason Shafrin, Center for Healthcare Economics and Policy, FTI Consulting, Los Angeles, CA, USA, Tel +1 213-452-6483, Email Jason.Shafrin@fticonsulting.comObjective: To measure the economic impact of conditionally essential amino acids (CEAA) among patients with operative treatment for fractures.Methods: A decision tree model was created to estimate changes in annual health care costs and quality of life impact due to complications after patients underwent operative treatment to address a traumatic fracture. The intervention of interest was the use of CEAA alongside standard of care as compared to standard of care alone. Patients were required to be aged ≥ 18 and receive the surgery in a US Level 1 trauma center. The primary outcomes were rates of post-surgical complications, changes in patient quality adjusted life years (QALYs), and changes in cost. Cost savings were modeled as the incremental costs (in 2022 USD) of treating complications due to changes in complication rates.Results: The per-patient cost of complications under CEAA use was &dollar;12,215 compared to &dollar;17,118 under standard of care without CEAA. The net incremental cost savings per patient with CEAA use was &dollar;4902, accounting for a two-week supply cost of CEAA. The differences in quality-adjusted life years (QALYs) under CEAA use and no CEAA use was 0.013 per person (0.739 vs 0.726). Modeled to the US population of patients requiring fracture fixations in trauma centers, the total value of CEAA use compared to no CEAA use was &dollar;316 million with an increase of 813 QALYs per year. With a gain of 0.013 QALYs per person, valued at &dollar;150,000, and the incremental cost savings of &dollar;4902 resulted in net monetary benefit of &dollar;6852 per patient. The incremental cost-effectiveness ratio showed that the use of CEAA dominated standard of care.Conclusion: CEAA use after fracture fixation surgery is cost saving. Level of Evidence: Level 1 Economic Study.Plain Language Summary: Postoperative complications after fracture fixation adversely impact clinical outcomes and impose substantial economic burden. Conditionally essential amino acids (CEAA) have been shown to reduce postoperative complication rates, but the economic impact is unclear.In this study, we quantify the impact of CEAA on health care costs and quality of life related to postoperative complications.The model demonstrates significant cost savings (&dollar;4902 per year per patient with operative treatment for fracture fixation) from the use of CEAA supplementation. Improving health outcomes and reducing health care costs for patients undergoing operative treatment for fracture fixation will be increasingly important for health systems as US payers increasingly shift provider reimbursement towards value-based care.Keywords: postoperative complications, orthopedic surgery, fracture fixation, oral nutritional supplement, economic impact postoperative complications

This study investigated the effects of oral nutritional supplements (ONSs) along with dietary counseling (DC) in community-dwelling older adults at risk of malnutrition. In this randomized controlled trial, 196 older adults who were at risk of malnutrition, as identified by the Malnutrition Universal Screening Tool (MUST) were randomly assigned to receive ONSs twice daily with DC (intervention) or DC-only (control) for 60 days. Primary outcome was change in body weight from baseline to day 60. Nutritional status, energy, and macronutrient intakes were measured. A significant larger weight gain was observed in the intervention compared to the control from baseline to day 60 (1.50 ± 0.22 kg, p < 0.0001). The intervention group also showed a significantly greater increase in weight at day 30 (p < 0.0001). Intakes of energy and macronutrients were significantly higher in the intervention group compared to the control group at both days 30 and 60 (all p < 0.0001). The odds of achieving better nutritional status were significantly higher in the intervention group than in the control group (OR:3.9, 95% CI: 1.9, 8.2, p = 0.0001). ONS supplementation combined with DC significantly improved body weight and nutritional outcomes in community-dwelling older adults at risk of malnutrition.

Malnutrition may result in abnormal biochemical and hematological indices. This planned prespecified analysis investigated the effects of a specialized oral nutritional supplement (ONS) on biochemical and hematological indices in community-dwelling older adults at risk of malnutrition. In the Strengthening Health in ELDerly through nutrition (SHIELD) study, 811 older adults aged 65 years and above took part in this randomized, double-blind, placebo-controlled, multi-center study. Participants were randomly allocated to either a complete and balanced specialized ONS (each serving provides 262 kcal, 10.5 g protein, 7.75 µg vitamin D3, and 0.74 g calcium β-hydroxy-β-methylbutyrate) and dietary counselling (intervention group) or a placebo and dietary counselling (placebo group). Both groups consumed study products twice a day for 180 days. Data were collected at baseline, day 90, and day 180. Blood analysis results at follow-up visits were analyzed using repeated measures analysis of covariance with adjustments for confounders. Overall, when compared with the placebo group, the intervention group showed significantly greater urea (6.0 mmol/L vs. 5.4 mmol/L, p < 0.001), urea to creatinine ratio (4.39 vs. 4.26, p < 0.001), prealbumin (24.9 mg/dL vs. 24.0 mg/dL, p < 0.001), vitamin B12 (480.0 pmol/L vs. 420.1 pmol/L, p < 0.001), and globulin levels (26.8 g/L vs. 26.5 g/L, p = 0.032). The intervention group also had a significantly higher absolute reticulocyte count (62.0 × 103/µL vs. 58.2 × 103/µL, overall p < 0.001) and mean platelet volume (10.0 fL vs. 9.9 fL, overall p = 0.003). Furthermore, significant improvements were seen in total protein at day 90 (71.7 g/L vs. 71.1 g/L, p = 0.017) and in absolute monocyte count at day 90 (0.50 × 103/µL vs. 0.47 × 103/µL, p = 0.009) in the intervention group. In conclusion, daily consumption of a specialized ONS for six months led to significant improvements in biochemical and hematological indices in community-dwelling older adults at risk of malnutrition.

Objective To explore the effect of marine bioactive peptides (MBP) combined with routine oral nutritional supplementation (ONS) on nutritional status in cancer patients, and to evaluate the effectiveness of nutritional support therapy. Methods A clinical randomized controlled trial was conducted on 108 patients with digestive tumors admitted in Shenzhen Hospital of Southern Medical University and the First Affiliated Hospital of Guangxi Medical University from September to November 2021. They were randomly divided into control group, ONS group and ONS+MBP group. All patients from the 3 groups received nutrition consultation and diet guidance to suggest balanced diet. ONS alone or combined with 18 g/d MBP were given to the patients of the ONS group and ONS+MBP group. The main observation indexes at admission and 8 weeks after intervention included NRS2002 score, PG-SGA score, body weight, body mass index (BMI), muscle mass, fat mass, upper arm muscle circumference, calf circumference, grip strength, and the secondary observation indexes included waist circumference, hip circumference, serum white blood cell count, red blood cell count, hemoglobin, albumin and total protein level. Results There were 36 patients from the control group, 33 from the ONS group and 30 from the ONS+MBP group completing the follow-up. No statistical differences were observed in the general clinical data among the 3 groups (P>0.05). After 8 weeks' follow-up, NRS2002 and PG-SGA scores were increased, but body weight, BMI, fat mass, upper arm muscle circumference, calf circumference, waist circumference, hip circumference, grip strength and albumin level were decreased in the control group. The body weight, BMI, muscle mass, fat mass, calf circumference, waist circumference, hip circumference, grip strength, serum albumin and total protein levels at 8 weeks after intervention were significantly increased in the ONS group and ONS+MBP group than the levels at admission and those of the control group after 8 weeks' follow-up. The ONS+MBP group also had obviously elevated body weight, BMI, muscle mass, fat mass, serum albumin and total protein levels and calf circumference when compared with those at admission. The patients of the ONS+MBP group showed significant increase in protein intake and notable decrease in PG-SGA score at 8 weeks (P < 0.05). Conclusion Cancer patients have a high risk for malnutrition, and intervention of ONS combined with MAP may have positive effects on improving their quality of life and extend their lives.

Summary: Background: Provision of feeds containing hydrolysed, peptide-based proteins and medium-chain triglycerides (MCT), can help mitigate gastrointestinal (GI) intolerance in adults with impaired GI function, maldigestion and/or malabsorption. Aim: This study evaluated a high-protein, peptide-based, MCT-containing oral nutritional supplement (PEHP; 1.5 kcal/mL and 7.5 g protein/100 mL). Methods: Adults with impaired GI function were recruited by their managing dietitian and took PEHP orally for 28-days, with GI tolerance, compliance, weight, energy and protein intake assessed via non-validated questionnaires and a 24-hour dietary recall at baseline and at intervention end. Results: Fifteen, adults (56 years (16), 67 kg (26.0), 24 kg/m2 (7.6)) took part in this study. Intensity of nausea (Z= -2.070, p=0.038, n=15) and abdominal pain (Z= -2.236, p=0.025, n=15) improved significantly compared to baseline. Reductions in the intensity of diarrhoea, constipation, vomiting, flatulence, and burping were observed but were not statistically significant (p>0.05 for all). Compliance was higher with PEHP (81% (24)) than baseline feeds (63% (42)) but not significantly. Weight remained stable between baseline (67 kg (26)) and at intervention end (67 kg (27), p=0.414, n=15). Compared to baseline, total energy intake increased with PEHP albeit not significantly (1661 kcal/day (572) vs 1981 kcal/day (592), p=0.137, n=15). Increases in total protein intake were also observed, this time significantly (61 g/day (23) vs 78 g/day (29), p=0.042, n=15). Conclusions: This study in adults with impaired GI function found that PEHP improved GI tolerance and protein intake compared to feeds taken at baseline (including both polymeric and peptide-based feeds).

This real-world study evaluated the evolution of the morphofunctional assessment of patients at risk of malnutrition using a leucine-enriched hyperproteic oral nutritional supplementation (ONS). A prospective observational one-arm study was used for 65 patients at risk of malnutrition, comparing medical nutrition therapy with an adapted diet and leucine-enriched ONS once or twice daily. All patients were studied at baseline and three months after intervention with a morphofunctional assessment. The age of patients was 57.99(17.97) years. Forty-three(66.2%) patients were women. A decrease in the percent of weight loss was observed after intervention (men: baseline = 6.38[8.64]%; 3 months = -1.48[4.42]%; p

High-energy, low-protein formulas (HE-LPFs) are commonly used as oral nutritional supplements (ONSs) to help provide extra calories to patients who are adhering to a low-protein diet (LPD) after diagnosis with chronic kidney disease (CKD). This randomized controlled trial aimed to evaluate the efficacy and safety of an HE-LPF as either a partial or a total replacement for one meal in pre-dialysis CKD patients. Stage 4–5 CKD patients received either a once-daily HE-LPF (HE-LPF group) or normal food (control group) for a period of 4 weeks while following an LPD. Overall, 73 patients who completed the study were included in the intention-to-treat population. After analyzing the 3-day food records, the HE-LPF group experienced a significant decrease in the percentage of energy derived from protein (p < 0.05) and an increase in the percentage of energy derived from fat (p < 0.05) compared to the control group. The two groups had no significant differences in body weight, body composition, grip strength, renal function, electrolytes, or metabolic markers. The HE-LPF group had a high adherence (94.9% at week 4), and no adverse effects were observed. HE-LPFs are safe to employ as meal replacements for pre-dialysis CKD patients adhering to an LPD. [ABSTRACT FROM AUTHOR]

The purpose of this study was to compare the effects of nutritional supplement drinks (NSDs) and nutritional education (NE) on the nutritional status and physical performance of older nursing home residents who were at risk of malnutrition. This study was a clustered, randomized, parallel, multi-center clinical trial, with 107 participants more than 65 years old and at risk of malnutrition recruited from several nursing homes in this study. Participants were divided into two groups: an NE group (n = 50) and an NSD group (n = 57). The NE group was given NE by a dietitian, while the NSD group was provided with two packs of NSD except receiving NE (Mei Balance, Meiji Holdings, Tokyo, Japan) per day as a snack between meals and before bed. Anthropometric data, blood pressure, nutritional status, blood biochemical biomarkers, and physical performance were measured before and after 12-week interventions. After 12 weeks of NE combined with NSD intervention, body weight, body-mass index, the mini nutritional assessment-short form (MNA-SF) score, walking speed, and SF-36 questionnaire score were improved in older nursing home residents at risk of malnutrition. [ABSTRACT FROM AUTHOR]

Abstract Background and objectives Malnutrition is prevalent in chronic hemodialysis (HD) patients. It increases mortality and negatively affects quality of life. This study aimed to assess the effect of intradialytic oral nutritional supplement (ONS) on nutritional markers in chronic HD patients with protein energy wasting (PEW). Methods This 3-month prospective, open-label, randomized controlled trial included 60 chronic HD patients with PEW. The intervention group (30 patients) received intradialytic ONS and dietary counseling, whereas the control group (30 patients) received only dietary counseling. Nutritional markers were measured at the beginning and end of the study. Results The mean age of the patients was 54 ± 12.7 years, and that of the HD vintage was 64 ± 49.3 months. Compared to the control group, the intervention group showed a significant increase in serum albumin (p

BackgroundThe prevention and treatment of malnutrition holds remarkable implications in the overall management of dialysis patients. However, there remains a dearth of comprehensive evaluations regarding the impact of oral nutrition supplement (ONS) on all pertinent dimensions of malnutrition in the dialysis population.MethodsA systematic search was conducted in MEDLINE, EMBASE, and Cochrane Central Library. RCTs that had assessed the effects of oral nutritional supplement in dialysis-dependent populations were considered eligible. Outcomes included laboratory indicators, anthropometric measures, nutritional indices, dialysis adequacy, body composition analysis measures, and systemic inflammation indicators. The risk of bias was assessed according to Cochrane guidelines. Weighted mean difference (WMD) or standardized mean difference (SMD) with 95% confidence intervals (CIs) were pooled using a random-effects model.ResultsIn all, 22 RCTs with 1,281 patients were included. The pooled analyses revealed the serum ALB, BMI, nPCR, and MIS improved by 1.44 g/L (95% CI: 0.76, 2.57), 0.35 kg/m2 (95% CI: 0.17, 0.52), 0.07 g/(kg d) (95% CI, 0.05, 0.10), and −2.75 (95% CI, −3.95, −1.54), respectively following ONS treatments when compared to control treatments. However, no significant differences were observed in relation to the other outcomes examined. 15 studies were rated as having high risk of bias. Visual inspection of the funnel plot and Egger test argued against the presence of publication bias.ConclusionONS treatments helps to improve the nutritional status of dialysis dependent patients. More evidence is needed from future investigations with longer study duration and standardized procedures to support long-term use of ONS in this population.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, Identifier CRD 42023441987.

IntroductionThere is an emerging need for plant-based, vegan options for patients requiring nutritional support.MethodsTwenty-four adults at risk of malnutrition (age: 59 years (SD 18); Sex: 18 female, 6 male; BMI: 19.0 kg/m2 (SD 3.3); multiple diagnoses) requiring plant-based nutritional support participated in a multi-center, prospective study of a (vegan suitable) multi-nutrient, ready-to-drink, oral nutritional supplement (ONS) [1.5 kcal/mL; 300 kcal, 12 g protein/200 mL bottle, mean prescription 275 mL/day (SD 115)] alongside dietary advice for 28 days. Compliance, anthropometry, malnutrition risk, dietary intake, appetite, acceptability, gastrointestinal (GI) tolerance, nutritional goal(s), and safety were assessed.ResultsPatients required a plant-based ONS due to personal preference/variety (33%), religious/cultural reasons (28%), veganism/reduce animal-derived consumption (17%), environmental/sustainability reasons (17%), and health reasons (5%). Compliance was 94% (SD 16). High risk of malnutrition (‘MUST’ score ≥ 2) reduced from 20 to 16 patients (p = 0.046). Body weight (+0.6 kg (SD 1.2), p = 0.02), BMI (+0.2 kg/m2 (SD 0.5), p = 0.03), total mean energy (+387 kcal/day (SD 416), p 0.06) with no serious adverse events related.DiscussionThis study highlights that plant-based nutrition support using a vegan-suitable plant-based ONS is highly complied with, improving the nutritional outcomes of patients at risk of malnutrition.

Methods: A randomized, double-blind, parallel-group, controlled, multicenter clinical trial was conducted in patients with cancer and malnutrition during outpatient treatment. Patients were randomized to receive either a specific high-calorie, high-protein ONS enriched with leucine, EPA, DHA, and β-glucans or an isocaloric, isonitrogenous standard ONS for eight weeks. Malnutrition was diagnosed using the SGA and body composition was evaluated using bioimpedance. Results: 57 patients were recruited and 37 completed the intervention period. After the nutritional intervention, patients who received the enhanced-ONS showed a significant increase in muscle mass, which was not detected with the standard ONS [1.92 (4.31) kg vs −0.68 (1.45) kg); p = 0.009)], and there was no significant reduction in the percentage of patients with severe and moderate malnutrition. Conclusion: An enhanced ONS enriched in EPA, DHA, leucine, and β-glucans increases muscle mass and could promote nutritional and functional status recovery in patients with cancer and malnourishment.Trial registration: NCT04184713.

Introduction: oral nutritional supplements specific for diabetes (DSF) usually have a composition that favors their palatability and simultaneous glycemic and metabolic control. Objective: to compare the sensory acceptability of a DSF with respect to a standard oral nutritional supplement (STF) in patients at risk of malnutrition with type 2 diabetes mellitus. Method: randomized, double-blind, crossover, multicenter, controlled, double-blind clinical trial. Odor, taste and perceived texture of a DSF and a STD were evaluated using a scale of 1 to 4. Results: twenty-nine patients were recruited and 58 organoleptic evaluations of the supplements were registered. A better evaluation of DSF was observed with respect to STD, although no statistically significant differences were reached: odor, 0.04 (CI 95 %) -0.49 to 0.56 (p = 0.092); taste, 0.14 (CI 95 %), -0.35 to 0.63 (p = 0.561); texture, 0.14 (CI 95 %), -0.43 to 0.72 (p = 0.619). No differences were found when analyzed by order of randomization, sex, degree of malnutrition, greater or lesser degree of complexity, greater or lesser time of evolution of diabetes, or by being older or younger. Conclusions: the specific nutritional supplement for diabetic patients formulated with extra virgin olive oil, EPA and DHA, a specific mixture of carbohydrates, and fiber, presented an adequate sensory acceptance by malnourished patients with type 2 diabetes mellitus. [ABSTRACT FROM AUTHOR]

Background and objectives: Malnutrition is prevalent in chronic hemodialysis (HD) patients. It increases mortality and negatively affects quality of life. This study aimed to assess the effect of intradialytic oral nutritional supplement (ONS) on nutritional markers in chronic HD patients with protein energy wasting (PEW). Methods: This 3-month prospective, open-label, randomized controlled trial included 60 chronic HD patients with PEW. The intervention group (30 patients) received intradialytic ONS and dietary counseling, whereas the control group (30 patients) received only dietary counseling. Nutritional markers were measured at the beginning and end of the study. Results: The mean age of the patients was 54 ± 12.7 years, and that of the HD vintage was 64 ± 49.3 months. Compared to the control group, the intervention group showed a significant increase in serum albumin (p < 0.001), prealbumin (p < 0.001), cholesterol (p = 0.016), body mass index (BMI) (p = 0.019), serum creatinine/body surface area (BSA) (p = 0.016), and composite French PEW score (p = 0.002), as well as a significant decrease in high-sensitivity C-reactive protein (hs-CRP) (p = 0.001). The total iron binding capacity, normalized protein nitrogen appearance, and hemoglobin levels increased significantly in both groups. Conclusion: Intradialytic ONS and dietary counseling for three months were more effective than dietary counseling alone in terms of improving nutritional status and inflammation in chronic HD patients, as evidenced by increases in serum albumin, prealbumin, BMI, serum creatinine/BSA, composite French PEW score, and a decrease in hs-CRP. [ABSTRACT FROM AUTHOR]

Background: non-institutionalized elderly patients who are prescribed an oral nutritional supplement (ONS) often have difficulties with compliance, which leads to physical deterioration and increases the risk of malnutrition. Objective: to assess improvement in the nutritional status of patients over 60 years of age, using the Mini Nutritional Assessment (MNA) score after the intervention of a nutritionist during a 6-month follow-up of malnourished patients with an indication for ONS. To demonstrate that the intervention of a nutritionist provides long-term improvements in the nutritional status of malnourished patients who are taking an ONS. Results: the nutritional intervention significantly improved BMI (from 22.9 ± 4.5 to 24.0 ± 4.1; p=0.001) and the MNA score (from 14.7 ± 4.4 to 20.4 ± 5.8; p<0.001) of the patients, as well as their perception of health (measured by VAS). Conclusions: the nutritional advice provided by a nutritionist to patients who were taking an ONS provided a high rate of adherence to treatment, which resulted in improvement in the nutritional status of patients. [ABSTRACT FROM AUTHOR]

Introduction: oral nutritional supplements (ONS) are nutritional therapies used to treat malnutrition in cancer patients, therefore, innovation in these treatments, from nutrients to sensory quality, is essential to ensure their consumption. Objectives: to evaluate the organoleptic characteristic of different prototypes of oral nutritional supplements specifically designed for cancer patients. Method: cross-sectional, randomized, double-blind pilot clinical study in patients with any type of cancer, with or without oncological treatment, who tasted five ONS prototypes with different flavors (brownie, tropical, pineapple, tomato and ham) and different sensory qualities in order to evaluate their organoleptic characteristics (color, smell, taste, residual taste, texture and density) through a specific questionnaire. Results: thirty patients aged 67.5 ± 11.2 years and body mass index (BMI) of 22.3 ± 3.52 kg/m2 were evaluated. The most prevalent tumors were head and neck (30 %), pancreas (20 %) and colon (17 %); 65 % of the patients had lost = 10 % of their body weight in six months. The best rated supplements by the cancer population were those with brownie flavor (23.67 ± 3.91 points) and tropical (20.33 ± 3.37 points), while the least valued were tomato (16.33 ± 5.44 points) and ham flavor (13.97 ± 4.64 points). Conclusions: cancer patients value the organoleptic characteristics of ONS with sweet flavors, such as brownie, and fruity flavors, such as tropical, much more positively. Less appreciated by these patients are those with a salty taste, such as ham and tomato flavor. [ABSTRACT FROM AUTHOR]

Objectives: To measure the cost savings and staff time savings of wound-specific oral nutritional supplements (WS-ONS) for patients with pressure injuries (PIs) in an average US nursing home in one year. Methods: Using evidence on how WS-ONS can impact PI healing time, we created a decision tree model to estimate changes in annual nursing home cost and staff time needed to treat PIs, between WS-ONS and standard of care. Cost savings were modeled as the reduced costs (in 2021 USD) of treating PIs due to improved healing time for a typical nursing home. Staff time was modeled using a time per task approach with tasks based on current PI treatment guidelines. The study period was one year, and the cost savings were measured from a US nursing home perspective. Results: A typical US nursing home with 85 residents would have 16 PI cases per year. Depending on the PI stage, WS-ONS reduced time to healing among patients with PI by 5.7 to 7.9 weeks compared to standard of care. WS-ONS use during PI reduced nursing home costs by $6,319 per patient for a Stage 2 PI, $7,651 per patient for a Stage 3 PI, and $16,579 per patient for a Stage 4 PI. The total cost savings from WS-ONS use at the nursing home level were $44,230 for Stage 2 PIs, $15,301 for Stage 3 PIs, and $49,737 for Stage 4 PIs. Across all stages, total annual cost savings for the typical US nursing home was $109,269. Nursing home staff time saving from WS-ONS administration was 65 hours per PI patient or 1,040 hours per nursing home per year. Implications: Nursing homes can realize reduced costs and staff time required to treat PIs from the use of WS-ONS among patients with PIs. Future research should uncover the suitable implementation strategies for nursing homes to use WS-ONS for appropriate patients with PI.

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.

Background: Progression diets after bariatric surgery (BS) are restricted in calories and protein, and they may induce a worsening of body composition. The aim of this study was to evaluate the effect of a modified diet with an oral nutritional supplement that is hyperproteic and normocaloric over the body composition. Methods: A two-arm ambispective observational cohort study was designed. Forty-four patients who underwent sleeve gastrectomy were included in the study. Thirty patients received a progression diet with a normocaloric, hyperproteic oral nutritional supplement during the first two weeks after surgery (820 kcal, 65.5 g protein). They were compared with a historical cohort of 14 patients treated with a standard progression diet (220 kcal, 11.5 g protein). Anthropometric and body composition (using electrical bioimpedanciometry) data were analyzed before BS and 1 month after the surgery. Results: The mean age was 47.35(10.22) years; 75% were women, and the average presurgical body mass index (BMI) was 45.98(6.13) kg/m2, with no differences between both arms of intervention. One month after surgery, no differences in the percentage of excess weight loss (%PEWL) were observed between patients in the high-protein-diet group (HP) and low-protein-diet group (LP) (HP: 21.86 (12.60)%; LP: 18.10 (13.49)%; p = 0.38). A lower loss of appendicular skeletal muscle mass index was observed in the HP (HP: −5.70 (8.79)%; LP: −10.54 (6.29)%; p < 0.05) and fat-free mass index (HP: 3.86 (8.50)%; LP:−9.44 (5.75)%; p = 0.03), while a higher loss of fat mass was observed in the HP (HP: −14.22 (10.09)%; LP: −5.26 (11.08)%; p < 0.01). Conclusions: In patients undergoing gastric sleeve surgery, the addition of a normocaloric, hyperproteic formula managed to slow down the loss of muscle mass and increase the loss of fat mass with no differences on total weight loss.

IntroductionPatient 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.MethodsA 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.ResultsFifty-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

Objectives: To measure the cost savings and staff time savings of wound-specific oral nutritional supplements (WS-ONS) for patients with pressure injuries (PIs) in an average US nursing home in one year. Methods: Using evidence on how WS-ONS can impact PI healing time, we created a decision tree model to estimate changes in annual nursing home cost and staff time needed to treat PIs, between WS-ONS and standard of care. Cost savings were modeled as the reduced costs (in 2021 USD) of treating PIs due to improved healing time for a typical nursing home. Staff time was modeled using a time per task approach with tasks based on current PI treatment guidelines. The study period was one year, and the cost savings were measured from a US nursing home perspective. Results: A typical US nursing home with 85 residents would have 16 PI cases per year. Depending on the PI stage, WS-ONS reduced time to healing among patients with PI by 5.7 to 7.9 weeks compared to standard of care. WS-ONS use during PI reduced nursing home costs by $6,319 per patient for a Stage 2 PI, $7,651 per patient for a Stage 3 PI, and $16,579 per patient for a Stage 4 PI. The total cost savings from WSONS use at the nursing home level were $44,230 for Stage 2 PIs, $15,301 for Stage 3 PIs, and $49,737 for Stage 4 PIs. Across all stages, total annual cost savings for the typical US nursing home was $109,269. Nursing home staff time saving from WS-ONS administration was 65 hours per PI patient or 1,040 hours per nursing home per year. Implications: Nursing homes can realize reduced costs and staff time required to treat PIs from the use of WS-ONS among patients with PIs. Future research should uncover the suitable implementation strategies for nursing homes to use WS-ONS for appropriate patients with PI. [ABSTRACT FROM AUTHOR]

High-energy, low-protein formulas (HE-LPFs) are commonly used as oral nutritional supplements (ONSs) to help provide extra calories to patients who are adhering to a low-protein diet (LPD) after diagnosis with chronic kidney disease (CKD). This randomized controlled trial aimed to evaluate the efficacy and safety of an HE-LPF as either a partial or a total replacement for one meal in pre-dialysis CKD patients. Stage 4–5 CKD patients received either a once-daily HE-LPF (HE-LPF group) or normal food (control group) for a period of 4 weeks while following an LPD. Overall, 73 patients who completed the study were included in the intention-to-treat population. After analyzing the 3-day food records, the HE-LPF group experienced a significant decrease in the percentage of energy derived from protein (p < 0.05) and an increase in the percentage of energy derived from fat (p < 0.05) compared to the control group. The two groups had no significant differences in body weight, body composition, grip strength, renal function, electrolytes, or metabolic markers. The HE-LPF group had a high adherence (94.9% at week 4), and no adverse effects were observed. HE-LPFs are safe to employ as meal replacements for pre-dialysis CKD patients adhering to an LPD.

The purpose of this study was to compare the effects of nutritional supplement drinks (NSDs) and nutritional education (NE) on the nutritional status and physical performance of older nursing home residents who were at risk of malnutrition. This study was a clustered, randomized, parallel, multi-center clinical trial, with 107 participants more than 65 years old and at risk of malnutrition recruited from several nursing homes in this study. Participants were divided into two groups: an NE group (n = 50) and an NSD group (n = 57). The NE group was given NE by a dietitian, while the NSD group was provided with two packs of NSD except receiving NE (Mei Balance, Meiji Holdings, Tokyo, Japan) per day as a snack between meals and before bed. Anthropometric data, blood pressure, nutritional status, blood biochemical biomarkers, and physical performance were measured before and after 12-week interventions. After 12 weeks of NE combined with NSD intervention, body weight, body-mass index, the mini nutritional assessment-short form (MNA-SF) score, walking speed, and SF-36 questionnaire score were improved in older nursing home residents at risk of malnutrition.

BackgroundMalnutrition 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 methodsRandomized, 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.ResultsA 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.ConclusionThe 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 registrationhttps://clinicaltrials.gov/ct2/show/, identifier NCT03924089.

Introduction: The prevalence of malnutrition in patients with diabetes mellitus is high. In these patients, monitoring nutritional intervention is complex. Aims: To evaluate the evolution in the nutritional status in patients with diabetes/prediabetes and malnutrition with a diabetes-specific enteral formula. Methods: Real-life study of one arm in 60 patients with diabetes and prediabetes, performing a dietary adaptation with diabetes-specific oral nutritional supplementation. A morphofunctional assessment was performed, consisting of intake assessment, anthropometry, body composition (bioimpedance and muscle ultrasound), handgrip strength and biochemical markers. The diagnosis of malnutrition was made using the criteria of the Global Leadership Initiative on Malnutrition (GLIM). The variables were measured at baseline and 3 months after starting the intervention. Results: The mean age was 67.13 (14.9) years. In total, 30 (50%) of the patients were women. Of the total, 60% of the patients had diabetes mellitus and 40% of the patients had prediabetes. The initial body mass index was 24.65 (5.35) kg/m2. It was observed that 80% of the patients had malnutrition, whereas after the intervention, the prevalence was 51.7% (p < 0.01). At the beginning of the study, 20% of the patients suffered from sarcopenia and after the intervention it was 16.7% (p = 0.19). Conclusions: Medical Nutrition Therapy with an adapted oral diet associated with diabetes-specific oral nutritional supplementation reduces malnutrition in patients at nutritional risk and disturbances of carbohydrate metabolism. [ABSTRACT FROM AUTHOR]

Objectives: the study describes the evolution over the years of the use of artificial nutrition, in particular after the introduction of a dedicated Clinical Nutrition and Dietetic Service. Methods: a single-center, retrospective observational study performed with data collected from 2014 to 2019 at the Regional Hospital of Locarno, Switzerland. Results: from 2014 to 2019, there has been an increase in the number of patients identified as being at risk of malnutrition. We observed a reduction in the use of parenteral nutrition in all services, especially after the introduction of the dedicated Clinical Nutrition and Dietetic Service. There would seem to be a switch from enteral to oral nutrition with increased use of oral nutritional supplements. Conclusions: the introduction of a dedicated Clinical Nutrition and Dietetic Service in the care of patients with nutritional issues would seem to reduce the use of artificial invasive nutrition, despite an increase in the number of patients identified as being at risk of malnutrition. [ABSTRACT FROM AUTHOR]

We assessed the impact of a recently reported nutritional quality improvement program (QIP) on healthcare resource utilization and costs for older, community-living adults in Bogotá, Colombia. The study included 618 community-dwelling, older adults (> 60 years) who were at risk or malnourished and receiving outpatient clinical care. The intervention was a QIP that emphasized nutritional screening, dietary education, lifestyle counseling, 60-day consumption of oral nutritional supplements, and 90-day follow-up. For economic modeling, we performed 90-day budget impact and cost-effectiveness analyses from a Colombian third-party payer perspective. The base-case analysis quantified mean healthcare resource use in the QIP study population. Analysis was based on mean input values (deterministic) and distributions of input parameters (probabilistic). As the deterministic analysis provided a simple point estimate, the cost-effectiveness analysis focused on the probabilistic results informed by 1000 iterations of a Monte-Carlo simulation. Results showed that the total use of healthcare resources over 90 days was significantly reduced by > 40% (hospitalizations were reduced by approximately 80%, emergency department visits by > 60%, and outpatient clinical visits by nearly 40%; P <.001). Based on economic modeling, total cost savings of $129 740 or per-patient cost savings of $210 over 90 days could be attributed to the use of nutritional QIP strategies. Total cost savings equated to nearly twice the initial investment for QIP intervention; that is, the per-dollar return on investment was $1.82. For older adults living in the community in Colombia, the use of our nutritional QIP improved health outcomes while lowering costs of healthcare and was thus cost-effective. • Among hospitalized adults, especially those of older age, nutrition-focused care can improve health outcomes while lowering costs, yet few studies have evaluated the impact of nutritional care for community-living older adults from the perspective of healthcare cost savings. • This is a first-of-its-kind study to assess the impact of nutrition-focused care for older community-living adults who were identified as at risk/malnourished in Colombia. Using real-world findings from a study of patients receiving outpatient care, we used economic modeling to do budget impact and cost-effectiveness analyses. Our results provided robust evidence supporting both health and economic benefits of improving nutritional care for older adults living in the community. • Our results showed that nutrition-focused care significantly reduced overall use of healthcare resources (hospitalizations, emergency department visits, and outpatient clinic visits) by more than 40%. Modeling revealed that a $210 per-patient net cost savings could be attributed to nutrition-focused outpatient care over the 90-day study period. Our evidence of value in nutritional care can help guide health policy and decision makers aiming to reduce the burden of healthcare costs in the aging Colombian population. [ABSTRACT FROM AUTHOR]

Introduction: Objectives: the study describes the evolution over the years of the use of artificial nutrition, in particular after the introduction of a dedicated Clinical Nutrition and Dietetic Service. Methods: a single-center, retrospective observational study performed with data collected from 2014 to 2019 at the Regional Hospital of Locarno, Switzerland. Results: from 2014 to 2019, there has been an increase in the number of patients identified as being at risk of malnutrition. We observed a reduction in the use of parenteral nutrition in all services, especially after the introduction of the dedicated Clinical Nutrition and Dietetic Service. There would seem to be a switch from enteral to oral nutrition with increased use of oral nutritional supplements. Conclusions: the introduction of a dedicated Clinical Nutrition and Dietetic Service in the care of patients with nutritional issues would seem to reduce the use of artificial invasive nutrition, despite an increase in the number of patients identified as being at risk of malnutrition. [ABSTRACT FROM AUTHOR]

BackgroundIncreasing life expectancy of coronary artery bypass grafting (CABG) remains to be the major concern of cardiac surgeons. However, few studies have investigated the effect of postoperative skeletal muscle index (SMI) loss on prognosis. This study aims to evaluate the prognostic role of postoperative SMI loss ≥ 5% after CABG, in order to develop a novel nomogram to predict overall survival (OS).MethodsPatients underwent CABG via midline sternotomy from December 2015 to March 2021 were recruited in this study. Preoperative and postoperative 3 months chest computed tomography (CT) images were compared to assess changes in SMI at T12 level. Based on this, patients were classified into the presence or absence of SMI loss ≥ 5%. The association between postoperative SMI loss ≥ 5% and OS was then analyzed by the Kaplan-Meier curves and Cox model. A novel nomogram incorporating independent clinical prognostic variables was also developed.ResultsThe study enrolled 506 patients receiving CABG, of whom 98 patients experienced T12 SMI loss ≥ 5% and had a significantly worse OS (P < 0.0001). Multivariate regression analysis showed that T12 SMI per cent change (%T12 SMI-change) was an independent prognostic factor for OS (HR = 0.809, 95% CI = 0.749–0.874). The nomogram incorporating %T12 SMI-change with other variables was accurate for predicting OS. Besides, we also found that postoperative oral nutritional supplement (ONS) can rescue T12 SMI loss.ConclusionPostoperative SMI loss can predict survival outcome after CABG. The nomogram incorporating changes in SMI provides a superior performance than existing systems.

A high-energy-type oral dietary supplement (ONS), with a low proportion of available carbohydrate (LC-ONS), which contains a slowly digestible carbohydrate, isomaltulose, and is fortified with soluble dietary fiber, was newly developed for individuals with diabetes or prediabetes. This study aimed to evaluate the impact of LC-ONS on blood glucose levels after ingestion in individuals with prediabetes. A single-blind, randomized crossover clinical trial was performed on 20 individuals with prediabetes. After overnight fasting, all subjects ingested one serving (200 kcal/125 mL) of either LC-ONS (40% energy proportion of available carbohydrates) or standard ONS (ST-ONS, 54% energy proportion of available carbohydrates) on two separate days. The incremental area under the curve of blood glucose levels for 120 min was significantly lower after LC-ONS ingestion compared to ST-ONS (2207 ± 391 mg/dL·min (least mean square value ± standard error) and 3735 ± 391 mg/dL·min, respectively; p < 0.001). The LC-ONS showed significantly lower blood glucose levels than the ST-ONS at all time points, except at baseline. Similarly, the incremental area under the curve of plasma insulin was significantly lower after LC-ONS ingestion. These results suggest that LC-ONS is useful as an ONS for energy supply in individuals with postprandial hyperglycemia. [ABSTRACT FROM AUTHOR]

Enhanced recovery after surgery(ERAS) has been a hot research topic of modern surgery, and the core of ERAS is based on a high level evidence-based medicine, aiming to reduce the influence of surgical trauma and stress on patients, reduce the risk of postoperative complications, shorten the length of hospital stay and reduce hospitalization expenses. Perioperative nutrition, especially in enteral nutrition intake is particularly important for the prognosis of patients. This paper summarized the clinical research progress of enteral nutrition, especially oral nutritional supplement, in fast-track surgery for colorectal cancer and to provide reference and basis for its safety and implementation strategy. (术后加速康复是现代外科的研究热点, 其核心理念是基于高水平的循证医学证据, 减少患者的手术创伤和应激, 从而减少术后并发症, 缩短住院时间, 减少住院费用, 而围术期营养特别是肠内营养的摄入对患者的预后具有特别重要的意义。本文总结了目前关于结直肠癌加速康复外科肠内营养实施的临床研究进展, 为其安全性和实施策略提供参考和依据。)

Tapioca-starch maltodextrin (TM) has recently been developed for various Dextrose Equivalents (DE), which may influence the physicochemical characteristics of a product. This study aimed to develop nutritionally complete oral nutrition supplement (ONS) by using TM DE7 and DE19 as carbohydrate sources. Two polymeric nutritionally complete ONS formulas containing TM, whey protein isolate, rice bran oil, vitamins, and minerals, were developed. Their difference was that one contained TM DE7 and the other DE19. Physical properties and sensory acceptance were evaluated. Both formulas provided similar amounts of energy (255 kcal), 36 g carbohydrate, 10 g protein, and 9 g fat per 250 ml. ONS TM DE7 formula had a significantly (p

Introduction: Aim: the objective of our real-life study was to evaluate adherence and taste preferences of a hypercaloric and hyperprotein oral nutritional supplement (ONS) in malnourished hospitalized patients. Methods: a total of 34 in patients with recent weight loss were included in this study. One flavor (coffe, vanilla or strawberry) was administered each day in a random way to each patient during three consecutive days. In the first three days, patients were asked to fulfill two questionnaires intended to reflect ONS (Renutryl®) tolerance and acceptance. Adherence to the ONS was measured during hospital stay. Results: the sweet flavor was higher for strawberry (4.54 ± 0.2 points) than for the vanilla flavor (3.13 ± 0.1 points; p < 0.03) and coffee flavor (3.03 ± 0.1 points; p <0.02). When analyzing the total number of patients who took supplements after choosing the flavor, the patients who chose coffee took a total of 13.3 ± 1.1 packages on average during hospitalization (0.91 ± 0.2 per day), the patients who chose strawberry took 13.4 ± 1.3 packages (0.92 ± 0.1 per day), and finally the patients who chose vanilla packages took 8.3 ± 0, 9 packages during admission (0.61 ± 0.1 per day), with significant differences in favor of the strawberry and coffee flavors versus vanilla. The ONS chosen mostly by the patients at hospital discharge was the multiflavor pack (n = 20; 50 %). Conclusions: taste preferences for the three flavored ONSs are similar, although adherence was higher during admission to the coffee- and strawberry-flavored ONS. Sweetness may have influenced this finding, especially with the strawberry flavor, with a good tolerance of all three flavors. [ABSTRACT FROM AUTHOR]

Introduction: Malnutrition is considered a risk factor among geriatric individuals with hip fracture, affecting functional healing and recovery, increasing healthcare spending, and associated with high mortality. In this study, we sought to evaluate the clinical efficacy of oral nutritional supplements in geriatric patients undergoing surgery for hip fracture. Material and Methods: We retrospectively analyzed data of 1625 consecutive patients who underwent fixation or arthroplasty for hip fracture in a tertiary medical center between 2017 and 2020. Patients who had no available albumin or body mass index levels were excluded. The study group is of patients who received an advanced formula in the form of an oral nutritional supplement (ONS), and the control group of patients that received no ONS. Peri- and postoperative complications, readmissions, short-term mortality, and albumin levels were compared between the 2 groups. Results: The final cohort included 1123 patients, 298 in the study group and 825 controls, with a follow-up of at least 1-year. Provision of the advanced enriched formula was not associated with 30-day, 90-day, or 1-year mortality (P = .62, P = .52, and P = .72, respectively) or any perioperative complications, such as 30-day or 90-day readmission (P = .37 and P = .1, respectively), revision surgery of any cause (P = .35), and postoperative infection rates (P = .73). Albumin levels on admission and the minimum albumin levels during hospitalization were similar between the groups, but they were significantly higher in the study group before discharge (33.42 g/L vs. 32.79 g/L, P = .01). Discussion: The use of an ONS was not associated with reduced perioperative complications or mortality, although it did affect nutritional status, as indicated by increased albumin levels, a known marker of nutritional status. Conclusions. While current findings do not support ONS use to minimize major postoperative complication after hip fracture surgery, further long-term study is warranted to evaluate subjective and functional outcomes associated with improved nutritional status. [ABSTRACT FROM AUTHOR]

This study investigated the effects of oral nutritional supplements (ONSs) along with dietary counseling (DC) in community-dwelling older adults at risk of malnutrition. In this randomized controlled trial, 196 older adults who were at risk of malnutrition, as identified by the Malnutrition Universal Screening Tool (MUST) were randomly assigned to receive ONSs twice daily with DC (intervention) or DC-only (control) for 60 days. Primary outcome was change in body weight from baseline to day 60. Nutritional status, energy, and macronutrient intakes were measured. A significant larger weight gain was observed in the intervention compared to the control from baseline to day 60 (1.50 ± 0.22 kg, p < 0.0001). The intervention group also showed a significantly greater increase in weight at day 30 ( p < 0.0001). Intakes of energy and macronutrients were significantly higher in the intervention group compared to the control group at both days 30 and 60 (all p < 0.0001). The odds of achieving better nutritional status were significantly higher in the intervention group than in the control group (OR:3.9, 95% CI: 1.9, 8.2, p = 0.0001). ONS supplementation combined with DC significantly improved body weight and nutritional outcomes in community-dwelling older adults at risk of malnutrition.

Background: Body weight loss (BWL) after gastrectomy is associated with not only a deteriorated quality of life but also a poor prognosis. Oral nutritional supplements (ONS) may be used to minimize BWL, which is observed in the first 3 months after gastrectomy and becomes stable thereafter, although the results of several randomized trials remain controversial. Methods: We performed a multicenter, open-label randomized controlled trial including 1003 gastric cancer patients undergoing curative gastrectomy. Patients were assigned to the ONS group or the control group. In the former, 400 ml (400 kcal) per day for 12 weeks as enteral nutrition was planned, and the actual intake amount was recorded daily by patients themselves. The primary endpoint was BWL 1 year after gastrectomy. Results: BWL data were available in 880 patients (ONS 437, control 443). BWL at 3 months was significantly lower in the ONS group than in the control group (7.1 ± 5.6% and 8.5 ± 5.8%, p = 0.0011). However, the difference gradually declined after 6 months and was not significant 1 year after surgery (9.3 ± 8.2% and 9.8 ± 8.7%, p = 0.37). In the ONS group, 50.4% of patients took more than 200 ml/day of ONS (average 301 ml) and showed significantly less BWL (8.2 ± 7.2%) at 1 year than the control (p = 0.0204). Conclusion: The administration of ONS for 12 weeks after gastrectomy did not improve BWL at 1 year. However, the improvement in BWL remained until 1 year after surgery in patients who took more than 200 kcal/day of ONS. [ABSTRACT FROM AUTHOR]

Introduction: Dry eye is a multifactorial condition of the eye caused by insufficient tear production and imbalance in tear composition leading to faster evaporation of tear fluid. It is also associated with inflammation that often leads to ocular surface damage. Symptoms of dry eyes include itchiness, soreness, red eyes, a burning sensation, eye fatigue and blurred vision. The objective of this study was to evaluate the efficacy and safety of our multi-ingredient supplement in subjects with dry eye syndrome (DES). Methods: We recruited 60 subjects with mild to moderate DES who were randomized in a 1:1 ratio in a single-center study to receive LCD (lutein 20 mg, zeaxanthin 4 mg, curcumin 200 mg curcuminoids, vitamin D3 600 IU) or placebo (soybean oil) capsules for 8 weeks. The primary outcomes evaluated were changes in tear volume by Schirmer's test and ocular symptoms by the Ocular Surface Disease Index (OSDI); secondary outcomes included evaluation of changes in Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, tear film break-up time (TBUT), corneal and conjunctival staining, tear osmolarity, matrix metalloproteinase-9 (MMP-9), artificial tear use and safety assessments. The outcomes were compared between the LCD and placebo groups at baseline and day 56 of supplementation. Results: Fifty-nine subjects, 30 from LCD and 29 from placebo group, completed the study. The LCD group showed significant improvements (P < 0.0001) for Schirmer's test, OSDI, TBUT, SPEED, ocular staining scores, tear osmolarity (P = 0.0005), MMP-9 (P = 0.0017) and reduced artificial tear use (P = 0.0004) and its frequency of use (P < 0.0001) in subjects compared to placebo from baseline to day 56. No safety issues were observed in the study. Conclusion: The LCD supplement showed significant improvements in the production, stability and quality of tears by reducing ocular surface damage and tear inflammation and can be used as an adjuvant to artificial tears in subjects with DES. Trial Registration: Clinical Trials Registry of India (http://ctri.nic.in/) identifier: CTRI/2021/01/030493. [ABSTRACT FROM AUTHOR]