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A preliminary randomized controlled trial of a ginger-containing, clear, fat-free oral nutritional Supplement for chemotherapy-induced nausea and nutritional outcomes 一项初步的随机对照试验,含姜,透明,无脂肪的口服营养补充剂对化疗引起的恶心和营养结果
Q3 Nursing Pub Date : 2026-01-21 DOI: 10.1016/j.nutos.2025.12.011
Rie Tsutsumi , Soshi Narasaki , Yousuke T. Horikawa , Yuna Izumi-Mishima , Sonoko Yasui-Yamada , Kazuhiro Nomura , Hiroshi Sakaue , Yasuo M. Tsutsumi

Purpose

Chemotherapy-induced nausea and vomiting (CINV) is a serious side effect, affecting approximately 40% of cancer patients and often hindering their ability to continue treatment. In this study, we evaluated the efficacy of an oral nutrition supplement (ONS) designed to decrease patients experiencing CINV.

Methods

A total of 98 patients were assessed for eligibility, and 75 patients were prospectively and randomly assigned to one of three groups: the control group without ONS (Control; n = 25), a fat-free clear ONS including ginger extract group (Ginger ONS; n = 25), or the Conventional ONS group (Conv ONS; n = 25). Data collection included Numerical Rating Scale (NRS) for nausea, number of vomiting episodes, use of antiemetic drugs, blood biochemical tests, serum substance P levels, Quality of Life (QOL) Assessment, and dietary intake.

Results

NRS for nausea scores after the second cycle of chemotherapy were 7.8 ± 1.8 in the Control group, 3.5 ± 1.4 in the Ginger ONS group, and 5.7 ± 1.9 in the Conv ONS group. Substance P levels decreased significantly in the Ginger ONS group compared to the Conv ONS and Control groups. In addition, the Ginger ONS group showed a significant improvement in energy and protein intake. Body weight and lean body mass were also improved. Finally, QOL was significantly improved in the Ginger ONS group following the second cycle of chemotherapy (P < 0.05).

Conclusions

Taken together, these data suggest that Ginger ONS is associated with improvements in nausea and energy/protein intake following chemotherapy. It is possible that comprehensive differences in nutritional composition—including the ginger extract, the amount and quality of protein, absence of fat, palatability, etc.—may have contributed to the observed outcomes.

Trial Registry

https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060201.
目的:血液疗法引起的恶心和呕吐(CINV)是一种严重的副作用,影响了大约40%的癌症患者,并经常阻碍他们继续治疗的能力。在这项研究中,我们评估了口服营养补充剂(ONS)旨在减少CINV患者的疗效。方法共对98例患者进行资格评估,其中75例患者被前瞻性随机分配到三组:不含ONS的对照组(control; n = 25)、含姜提取物的无脂透明ONS组(ginger ONS; n = 25)和常规ONS组(Conv ONS; n = 25)。数据收集包括恶心、呕吐次数、止吐药物使用、血液生化测试、血清P物质水平、生活质量(QOL)评估和饮食摄入的数值评定量表(NRS)。结果对照组第二周期化疗后恶心评分snrs为7.8±1.8,生姜组为3.5±1.4,Conv组为5.7±1.9。与对照组和对照组相比,生姜组的P物质水平显著下降。此外,生姜组在能量和蛋白质摄入方面也有显著改善。体重和瘦体重也有所改善。最后,生姜ONS组在第二周期化疗后生活质量显著改善(P < 0.05)。综上所述,这些数据表明生姜ONS与化疗后恶心和能量/蛋白质摄入的改善有关。可能是营养成分的综合差异——包括生姜提取物、蛋白质的数量和质量、脂肪的缺乏、适口性等——导致了观察到的结果。试用Registryhttps: / / center6.umin.ac.jp / cgi-open-bin / ctr_e / ctr_view.cgi ? recptno = R000060201。
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引用次数: 0
Effects of ubiquinol on metabolic profile in prediabetic patients: A randomized, double-blinded, placebo-controlled pilot study 泛醇对糖尿病前期患者代谢谱的影响:一项随机、双盲、安慰剂对照的初步研究
Q3 Nursing Pub Date : 2026-01-17 DOI: 10.1016/j.nutos.2026.100627
Pasita Palakornkitti , Romun Leaovitavat , Paphitchaya Thetsana , Patana Teng-umnuay

Background/objectives

Prediabetes not only increase the risk of developing diabetes, but it is also associated with the development of cardiovascular disease, chronic kidney disease, neuropathy, and retinopathy. Oxidative stress is a well-known contributor to its pathogenesis. This study aimed to examine the potential benefit effect of ubiquinol supplementation, a lipophilic antioxidant, on metabolic profile in prediabetic patients.

Methods

This prospective, randomized, double-blind, placebo-controlled pilot study enrolled 20 adults with impaired fasting plasma glucose (FPG), who were randomly assigned to receive ubiquinol (100 mg per day) or placebo. Metabolic profile including FPG, hemoglobin A1C (HbA1C), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR), total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride (TG) was assessed after 12-week treatment period. Between-group differences were analyzed according to the intention-to-treat principle, with effect sizes calculated to estimate the magnitude of observed effects.

Results

HOMA-IR was significantly lower in ubiquinol group compared to placebo group at week 12 (P = 0.028), with a moderate effect size (r =0.490). Median (range) HOMA-IR reduced from 2.23 (0.97) to 1.66 (0.39) for ubiquinol group while increased from 2.20 (0.90) to 2.35 (1.90) for placebo group. No significant difference in other outcome was reported. However, moderate-to-large effect sizes were observed for FPG, HbA1C, and fasting insulin.

Conclusions

Daily supplementation of 100-mg ubiquinol for 12 weeks improves insulin sensitivity for prediabetic patients with a favorable safety profile. The observed effect sizes support further investigation in larger, adequately powered trials to confirm the metabolic effects of ubiquinol.
背景/目的糖尿病前期不仅增加患糖尿病的风险,而且还与心血管疾病、慢性肾病、神经病变和视网膜病变的发生有关。氧化应激是其发病机制的一个众所周知的因素。本研究旨在研究补充泛醇(一种亲脂性抗氧化剂)对糖尿病前期患者代谢谱的潜在益处。这项前瞻性、随机、双盲、安慰剂对照的初步研究招募了20名空腹血糖(FPG)受损的成年人,他们被随机分配接受泛醇(每天100毫克)或安慰剂。在12周的治疗期后,评估代谢谱,包括FPG、血红蛋白A1C (HbA1C)、空腹胰岛素、胰岛素抵抗稳态模型评估(HOMA-IR)、总胆固醇、低密度脂蛋白(LDL)、高密度脂蛋白(HDL)和甘油三酯(TG)。根据意向治疗原则分析组间差异,计算效应量以估计观察到的效应的大小。结果在第12周,泛醇组的shoma - ir显著低于安慰剂组(P = 0.028),且效应大小中等(r =0.490)。泛醇组的HOMA-IR中位数(范围)从2.23(0.97)下降到1.66(0.39),而安慰剂组从2.20(0.90)上升到2.35(1.90)。其他结果无显著差异。然而,在FPG、HbA1C和空腹胰岛素方面观察到中等到较大的效应。结论:每日补充100 mg泛醇12周可改善糖尿病前期患者的胰岛素敏感性,且具有良好的安全性。观察到的效应大小支持在更大、足够有力的试验中进一步研究,以确认泛醇的代谢作用。
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引用次数: 0
Changes in taste and smell function during adjuvant chemotherapy in patients with colon cancer: A prospective cohort study 结肠癌患者辅助化疗期间味觉和嗅觉功能的变化:一项前瞻性队列研究
Q3 Nursing Pub Date : 2026-01-13 DOI: 10.1016/j.nutos.2026.100626
K. Beukers , A.J. van de Wouw , R.C. Havermans , M.L.G. Janssen-Heijnen

Background & aims

Adjuvant chemotherapy for high-risk stage II or stage III colon cancer improves survival, but frequently induces side effects, including changes in taste (hypogeusia) and smell (hyposmia) function. These alterations in taste and smell function may reduce appetite and nutritional intake, increasing the risk of malnutrition and compromising treatment tolerance and quality of life. Objective data on these changes during chemotherapy are limited. The aim of this study was to investigate changes in taste and smell function during adjuvant chemotherapy in patients with colon cancer.

Methods

In this relatively small prospective cohort study, eleven patients with high-risk stage II or III colon cancer receiving capecitabine or CAPOX were included. Taste and smell function were assessed using Taste Strips and Sniffin’ Sticks before, during, and after chemotherapy. Paired-samples t-tests compared taste and smell function at each time point to baseline.

Results

Significant declines in taste (T1; mean difference = -1.33, p = 0.022) and smell (T1; mean difference = -5.11, p = 0.017) were observed after the first chemotherapy cycle. Baseline hypogeusia and hyposmia were present in 33% and 44% of patients, respectively. During treatment, hypogeusia ranged from 33–44% and hyposmia from 44–78%, with marked inter- and intra-individual variability. While most patients maintained normogeusia, hyposmia was more common at multiple time points.

Conclusion

Adjuvant chemotherapy is associated with clinically relevant, but heterogeneous changes in taste and smell, particularly during the initial phase of chemotherapy. These alterations may impair nutritional intake, highlighting the need for early, individualized dietary interventions. Combining objective and patient-reported assessments may optimize supportive care, enhancing treatment tolerance and quality of life. Despite the small sample size, which substantially limits generalizability, the in-depth analysis highlights significant variability in taste and smell function both between patients and across chemotherapy cycles, highlighting that chemosensory changes are neither uniform nor static.
背景和目的对高危II期或III期结肠癌进行辅助化疗可提高生存率,但往往会引起副作用,包括味觉(味觉减退)和嗅觉(嗅觉减退)功能的改变。味觉和嗅觉功能的这些改变可能会降低食欲和营养摄入,增加营养不良的风险,损害治疗耐受性和生活质量。化疗期间这些变化的客观数据是有限的。本研究的目的是研究结肠癌患者在辅助化疗期间味觉和嗅觉功能的变化。方法在这项相对较小的前瞻性队列研究中,纳入了11例接受卡培他滨或CAPOX治疗的高风险II期或III期结肠癌患者。在化疗前、化疗中和化疗后分别用味觉条和嗅探棒评估味觉和嗅觉功能。配对样本t检验将每个时间点的味觉和嗅觉功能与基线进行比较。结果在第一个化疗周期后,味觉(T1,平均差值= -1.33,p = 0.022)和嗅觉(T1,平均差值= -5.11,p = 0.017)明显下降。基线缺氧和低血症分别出现在33%和44%的患者中。在治疗期间,缺氧的范围为33-44%,缺氧的范围为44-78%,具有显著的个体间和个体内变异性。虽然大多数患者保持正常睡眠,但低睡眠在多个时间点更为常见。结论辅助化疗与临床相关但异质性的味觉和嗅觉变化有关,特别是在化疗初期。这些改变可能会影响营养摄入,因此需要尽早进行个性化的饮食干预。结合客观和患者报告的评估可以优化支持治疗,提高治疗耐受性和生活质量。尽管样本量小,这在很大程度上限制了普遍性,但深入的分析强调了患者之间和整个化疗周期的味觉和嗅觉功能的显著差异,强调了化学感觉的变化既不是均匀的也不是静态的。
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引用次数: 0
A multicenter study evaluating the gastrointestinal tolerance and acceptability of a novel high-energy, high-protein, plant-based enteral tube feed for adults 一项多中心研究评估了一种新型高能量、高蛋白、植物性成人肠内管饲料的胃肠耐受性和可接受性
Q3 Nursing Pub Date : 2026-01-05 DOI: 10.1016/j.nutos.2025.100624
James Evans , Antonino Salvia , Rosa Maria Burgos , Fernanda Mucarzel , Sharan Saduera

Background & Aims

In 2023, 2.6 million Europeans were estimated to be vegan, approximately 3 % of the European population. Few plant-based products exist for patients who need tube feeding. Furthermore, the tube-fed population often have gastrointestinal intolerance to milk-based proteins due to underlying pathology. A plant-based feed may be better tolerated. This study aimed to evaluate acceptability, compliance and gastrointestinal tolerance of a novel high-energy, high-protein, plant-based enteral tube feed.

Methods

A single-arm, prospective study in three centers was conducted. Adults ≥16 years, established on a tube feed for disease-related malnutrition which provided ≥50 % of energy requirements were included. Patients were swapped from their usual feed to the study product Compleat® plant protein 1.6 (a plant-based, high-energy, high-protein tube feed) for seven days. Acceptability (patient satisfaction), compliance (volume of feed taken versus prescribed) and gastrointestinal tolerance (diarrhea, constipation, vomiting, nausea) were assessed by self-reported questionnaire. This included multiple-choice questions, Likert scales and free text comments.

Results

Twenty-one patients were recruited, of which five withdrew, two due to worsening gastrointestinal symptoms with the study product. Sixteen patients completed data collection, mean age 53.3 years, 44 % female, 56 % had cancer, 75 % had a gastrostomy. Mean daily volume of Compleat® plant protein 1.6 consumed versus prescribed was 992 mL v 1058 mL (94 % compliance). Mean calorie and protein intake was 1555 kcals and 82.6 g respectively and 69 % tolerated the study feed with no change in gastrointestinal symptoms compared to baseline, whilst 25 % reported significant improvements in their gastrointestinal symptoms. Forty four percent were satisfied with the new feed, 38 % were neither satisfied nor dissatisfied.

Conclusions

Compleat® plant protein 1.6 was very acceptable to patients and associated with high levels of compliance and good gastrointestinal tolerance. For patients who follow a plant-based diet Compleat® plant protein 1.6 offers an innovative enteral tube feed that does not contain added milk or soya ingredients. Clinicians could consider this feed when patients have gastrointestinal intolerance to a milk-based feed.
2023年,估计有260万欧洲人是素食主义者,约占欧洲人口的3%。很少有植物性产品适合需要管饲的患者。此外,由于潜在的病理,管饲人群往往对乳基蛋白有胃肠道不耐受。植物性饲料的耐受性可能更好。本研究旨在评估一种新型高能量、高蛋白、植物性肠内管饲料的可接受性、依从性和胃肠道耐受性。方法在三个中心进行单臂前瞻性研究。纳入年龄≥16岁、因疾病相关营养不良而采用管饲且能提供≥50%能量需求的成年人。患者从常规饲料切换到研究产品Compleat®植物蛋白1.6(一种基于植物的高能量高蛋白管饲)7天。可接受性(患者满意度)、依从性(服用饲料量与处方量)和胃肠耐受性(腹泻、便秘、呕吐、恶心)通过自我报告问卷进行评估。这包括多项选择题、李克特量表和自由文本评论。结果共纳入21例患者,其中5例退出,2例因使用本研究产品后胃肠道症状恶化。16例患者完成资料收集,平均年龄53.3岁,44%为女性,56%为癌症,75%为胃造口术。与处方相比,Compleat®植物蛋白1.6的平均每日用量为992 mL vs 1058 mL(94%的依从性)。平均卡路里和蛋白质摄入量分别为1555千卡和82.6克,69%的人耐受研究饲料,胃肠道症状与基线相比没有变化,而25%的人报告胃肠道症状有显着改善。44%的人对新饲料感到满意,38%的人既不满意也不满意。结论compleat®植物蛋白1.6对患者非常可接受,具有较高的依从性和良好的胃肠耐受性。对于遵循植物性饮食的患者,Compleat®植物蛋白1.6提供了一种创新的肠内管饲料,不含添加牛奶或大豆成分。当患者对乳基饲料有胃肠道不耐受时,临床医生可以考虑使用这种饲料。
{"title":"A multicenter study evaluating the gastrointestinal tolerance and acceptability of a novel high-energy, high-protein, plant-based enteral tube feed for adults","authors":"James Evans ,&nbsp;Antonino Salvia ,&nbsp;Rosa Maria Burgos ,&nbsp;Fernanda Mucarzel ,&nbsp;Sharan Saduera","doi":"10.1016/j.nutos.2025.100624","DOIUrl":"10.1016/j.nutos.2025.100624","url":null,"abstract":"<div><h3>Background &amp; Aims</h3><div>In 2023, 2.6 million Europeans were estimated to be vegan, approximately 3 % of the European population. Few plant-based products exist for patients who need tube feeding. Furthermore, the tube-fed population often have gastrointestinal intolerance to milk-based proteins due to underlying pathology. A plant-based feed may be better tolerated. This study aimed to evaluate acceptability, compliance and gastrointestinal tolerance of a novel high-energy, high-protein, plant-based enteral tube feed.</div></div><div><h3>Methods</h3><div>A single-arm, prospective study in three centers was conducted. Adults ≥16 years, established on a tube feed for disease-related malnutrition which provided ≥50 % of energy requirements were included. Patients were swapped from their usual feed to the study product Compleat® plant protein 1.6 (a plant-based, high-energy, high-protein tube feed) for seven days. Acceptability (patient satisfaction), compliance (volume of feed taken versus prescribed) and gastrointestinal tolerance (diarrhea, constipation, vomiting, nausea) were assessed by self-reported questionnaire. This included multiple-choice questions, Likert scales and free text comments.</div></div><div><h3>Results</h3><div>Twenty-one patients were recruited, of which five withdrew, two due to worsening gastrointestinal symptoms with the study product. Sixteen patients completed data collection, mean age 53.3 years, 44 % female, 56 % had cancer, 75 % had a gastrostomy. Mean daily volume of Compleat® plant protein 1.6 consumed versus prescribed was 992 mL v 1058 mL (94 % compliance). Mean calorie and protein intake was 1555 kcals and 82.6 g respectively and 69 % tolerated the study feed with no change in gastrointestinal symptoms compared to baseline, whilst 25 % reported significant improvements in their gastrointestinal symptoms. Forty four percent were satisfied with the new feed, 38 % were neither satisfied nor dissatisfied.</div></div><div><h3>Conclusions</h3><div>Compleat® plant protein 1.6 was very acceptable to patients and associated with high levels of compliance and good gastrointestinal tolerance. For patients who follow a plant-based diet Compleat® plant protein 1.6 offers an innovative enteral tube feed that does not contain added milk or soya ingredients. Clinicians could consider this feed when patients have gastrointestinal intolerance to a milk-based feed.</div></div>","PeriodicalId":36134,"journal":{"name":"Clinical Nutrition Open Science","volume":"65 ","pages":"Article 100624"},"PeriodicalIF":0.0,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145979062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A novel egg white-based solid oral nutritional supplement improves serum albumin and protein intake in patients on peritoneal dialysis: A prospective interventional study 一种新型蛋清固体口服营养补充剂可改善腹膜透析患者的血清白蛋白和蛋白质摄入量:一项前瞻性介入研究
Q3 Nursing Pub Date : 2026-01-02 DOI: 10.1016/j.nutos.2025.100621
Yupa Chanwikrai , Kamonwan Jongsomchai , Guttiga Halue , Donkum Kaewboonsert , Sawitree Suwannasang , Wittawas Sajjapong

Background & aims

Protein-energy wasting (PEW) is a major predictor of adverse outcomes in patients undergoing continuous ambulatory peritoneal dialysis (CAPD). Achieving the recommended dietary protein intake remains a significant clinical challenge. This study aimed to evaluate the safety and efficacy of “Egg Bite,” a novel, palatable, solid oral nutritional supplement (ONS) derived from egg white, in improving the nutritional status of CAPD patients.

Methods

In this prospective, single-arm interventional trial, 35 CAPD patients with serum albumin ≤ 4.0 g/dL consumed a daily supplement of “Egg Bite” (105 g/day, providing 25.7 g protein and 392 kcal) for 21 consecutive days. The primary outcome was the change in serum albumin. Secondary outcomes included changes in overall dietary intake, anthropometric measures, and key biochemical markers (renal, metabolic, and inflammatory). Assessments were performed at baseline, day 14, and day 21.

Results

Thirty-five of 42 enrolled patients (83%) completed the study. Daily supplementation resulted in a significant increase in mean serum albumin from 3.38 ± 0.42 g/dL at baseline to 3.48 ± 0.43 g/dL at day 21 (P = 0.001). Total protein intake rose significantly from 0.9 ± 0.2 g/kg/day to 1.4 ± 0.4 g/kg/day (P < 0.001), successfully meeting guideline recommendations. Energy intake also increased significantly (P < 0.001). No significant changes were observed in body weight or BMI. The supplement was well-tolerated, with non-significant increases in serum potassium and stable hemoglobin levels. Minor but statistically significant increases in BUN and creatinine were noted, consistent with increased protein metabolism. In patients with baseline hypoalbuminemia (n=19), hs-CRP showed a non-significant downward trend from 10.44 to 8.10 mg/dL.

Conclusions

Daily supplementation with “Egg Bite,” a novel egg white-based solid ONS, is a safe, well-tolerated, and effective intervention for improving protein-energy status in CAPD patients. It significantly elevates serum albumin and dietary protein intake to meet clinical targets without inducing adverse metabolic effects. “Egg Bite” represents a promising tool for managing PEW, though longer-term studies are needed to evaluate its impact on body composition and clinical outcomes.
背景和目的蛋白能量浪费(PEW)是持续动态腹膜透析(CAPD)患者不良结局的主要预测因子。达到推荐的膳食蛋白质摄入量仍然是一个重大的临床挑战。本研究旨在评估“蛋咬”的安全性和有效性,“蛋咬”是一种从蛋清中提取的新型、美味的固体口服营养补充剂(ONS),可改善CAPD患者的营养状况。方法在这项前瞻性单组干预性试验中,35例血清白蛋白≤4.0 g/dL的CAPD患者连续21天每天补充“Egg Bite”(105 g/d,提供25.7 g蛋白质和392 kcal)。主要结果是血清白蛋白的变化。次要结局包括总体饮食摄入量、人体测量指标和关键生化指标(肾脏、代谢和炎症)的变化。在基线、第14天和第21天进行评估。结果42例入组患者中有35例(83%)完成了研究。每日补充导致平均血清白蛋白从基线时的3.38±0.42 g/dL显著增加到第21天的3.48±0.43 g/dL (P = 0.001)。总蛋白质摄入量从0.9±0.2 g/kg/天显著增加到1.4±0.4 g/kg/天(P < 0.001),成功满足指南建议。能量摄入也显著增加(P < 0.001)。没有观察到体重或身体质量指数的显著变化。补充剂耐受性良好,血清钾无显著增加,血红蛋白水平稳定。BUN和肌酐轻微但有统计学意义的增加,与蛋白质代谢增加一致。在基线低白蛋白血症患者(n=19)中,hs-CRP从10.44降至8.10 mg/dL呈非显著性下降趋势。结论:每日补充“蛋咬”是一种新型的基于蛋清的固体ONS,是一种安全、耐受性良好且有效的干预措施,可改善CAPD患者的蛋白质能量状态。可显著提高血清白蛋白和膳食蛋白质摄入量,达到临床指标,且不引起不良代谢反应。“咬鸡蛋”代表了一个很有前途的管理PEW的工具,尽管需要更长期的研究来评估它对身体成分和临床结果的影响。
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引用次数: 0
Linguistic and content validation of the patient-generated subjective global assessment (PG-SGA) in Indonesian for use by cancer patients and healthcare professionals 为癌症患者和医疗保健专业人员使用的印度尼西亚语患者生成的主观整体评估(PG-SGA)的语言和内容验证
Q3 Nursing Pub Date : 2025-12-31 DOI: 10.1016/j.nutos.2025.12.013
Annela Manurung , Marcellus Simadibrata , Andri Sanityoso S , Ikhwan Rinaldi , Faith D. Ottery

Background

Assessment of malnutrition is important in cancer patients, especially in gastrointestinal cancer in Indonesia. The Scored Patient-Generated Subjective Global Assessment (PG-SGA), an instrument that allows interdisciplinary assessment of malnutrition and its risk factors, has yet to be available in the Indonesian version.

Object

To produce a valid and reliable PG-SGA questionnaire in Indonesian while maintaining the English version’s form, purpose, and meaning.

Methods

The PG-SGA questionnaire was translated, culturally and linguistically adapted, following the International Society for Pharmacoeconomics (ISPOR) principles. Each question item in the questionnaire will be assessed based on content validity, comprehensibility, and difficulty, operationalized by calculating item and scale indices. A scaled score of 0.80–0.90 is considered acceptable, while a score of more than 0.90 is considered excellent.

Results

The content validity of the entire PG-SGA questionnaire obtained an S-CVI of 0.92. The content validity score of the PG-SGA questionnaire on professional participants was S-CVI 0.91. The comprehensibility score of professional and general public participants was S–CI 0.89. The score for the difficulty of question items on the PG-SGA questionnaire with professional and general public participants obtained the results of S-DI 0.86 and 0.88.

Conclusion

The translation and cultural adaptation of the PG-SGA questionnaire according to the ISPOR principles of successfully maintaining the format, purpose, and meaning of the Indonesian version of the PG-SGA questionnaire. The PG-SGA questionnaire’s Indonesian version is now comprehensible and relevant for patients, the general public, and professionals. However, there are components of the professional questions that are considered difficult, so additional descriptions or brief explanations and training are needed, especially for physical examinations.
在印度尼西亚,对癌症患者,特别是胃肠道癌症患者进行营养不良评估是很重要的。评分的患者生成主观全球评估(PG-SGA)是一种允许对营养不良及其风险因素进行跨学科评估的工具,但印尼版本尚未提供。目的制作一份有效可靠的印尼语PG-SGA问卷,同时保留英语版本的形式、目的和含义。方法按照国际药物经济学学会(ISPOR)的原则,对PG-SGA问卷进行翻译、文化和语言调整。问卷中的每个问题将根据内容效度,可理解性和难度进行评估,通过计算项目和量表指数进行操作。0.80-0.90的分数被认为是可以接受的,而超过0.90的分数被认为是优秀的。结果PG-SGA问卷的内容效度S-CVI为0.92。专业参与者PG-SGA问卷的内容效度得分为S-CVI 0.91。专业和一般公众被试的可理解性得分S-CI为0.89。专业和普通公众参与的PG-SGA问卷题目难度得分分别为S-DI 0.86和0.88。结论根据ISPOR原则对PG-SGA问卷进行翻译和文化改编,成功保持了印尼语PG-SGA问卷的格式、目的和意义。PG-SGA问卷的印尼语版本现在对患者、公众和专业人员来说是可理解和相关的。然而,有些专业问题的组成部分被认为是困难的,因此需要额外的描述或简短的解释和培训,特别是对于身体检查。
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引用次数: 0
The impact on ICU patients of new enteral nutrition formula designed to maintain autophagy that is low in carbohydrates and leucine and high in lipids 旨在维持低碳水化合物和亮氨酸、高脂质自噬的新型肠内营养配方对ICU患者的影响
Q3 Nursing Pub Date : 2025-12-31 DOI: 10.1016/j.nutos.2025.100623
Shuhei Maruyama , Daiki Wada , Shuji Kanayama , Hiromu Iwamura , Junya Shimazaki , Tomoyuki Yoshihara , Fukuki Saito , Kazuhisa Yoshiya , Tomohiro Kagawa , Ryosuke Akiyama , Ippei Yamaoka , Yasushi Nakamori , Yasuyuki Kuwagata
<div><h3>Background & aims</h3><div>Given that the ESPEN 2019 guidelines state that “severe hypophosphatemia may lead to death after the initiation of feeding in patients admitted to intensive care unit (ICU),” we have been developing enteral nutrition (EN) formulas designed to reduce the risk of hypophosphatemia. Preliminary research indicates that high glucose concentrations and leucine-rich peptides are associated with hypophosphatemia across EN formulas with varying nutrient compositions. Additionally, recent randomized controlled trials have shown that high macronutrient doses, irrespective of the delivery route, may be harmful during the acute phase of critical illness, possibly due to the suppression of autophagy and ketogenesis, overfeeding-related hyperglycemia, and increased insulin requirements. EN formulas with lower glucose and leucine contents and higher lipid concentrations may activate autophagy and ketogenesis by inhibiting the mammalian target of rapamycin (mTOR) pathway. This study aimed to evaluate the clinical effect of a newly developed EN formula in critically ill patients.</div></div><div><h3>Methods</h3><div>A newly developed EN formula was launched in September 2023. The composition of the new EN product is characterised by being low in carbohydrates, high in protein from peptides with low leucine content, and high in lipids. This single-center, retrospective cohort study was conducted in Japan to compare clinical outcomes between the new EN formula and the standard formula. Eligible patients were those admitted to the ICU for at least 10 days and requiring invasive mechanical ventilation for at least 3 days. Patients were categorized into the new EN group or standard EN group based on the enteral formula they received. The primary outcome was in-hospital mortality. Secondary outcomes included insulin doses and electrolyte levels (potassium, phosphate, and magnesium), bowel movement frequency, and the incidence of bowel ischemia. The baseline characteristics were adjusted using propensity score matching (PSM) and inverse probability of treatment weighting (IPTW), followed by multivariate logistic regression analysis.</div></div><div><h3>Results</h3><div>Among the 689 eligible patients, 262 were assigned to the new EN group and 427 to the standard EN group. After PSM, 230 patients were included in each group. In IPTW analysis, 682 patients with complete data were included in the weighted population. The doses of insulin and electrolytes (potassium, phosphate, and magnesium) were consistently lower in the new EN group in both PSM and IPTW analyses. The in-hospital mortality was significantly lower in the new EN group than in the standard EN group (25 [10.9%] vs. 48 [20.9%], <em>P</em> = 0.006 after PSM; <em>P</em> = 0.002 after IPTW). Logistic regression analysis demonstrated that the new EN formulation was significantly associated with reduced in-hospital mortality both after PSM (OR: 0.46, 95% CI: 0.25–0.80, <em>P</e
背景和目的鉴于ESPEN 2019指南指出“重症监护病房(ICU)入院患者开始进食后严重低磷血症可能导致死亡”,我们一直在开发旨在降低低磷血症风险的肠内营养(EN)配方。初步研究表明,在不同营养成分的EN配方中,高葡萄糖浓度和富含亮氨酸的肽与低磷血症有关。此外,最近的随机对照试验表明,在危重疾病的急性期,高剂量的宏量营养素,无论其给药途径如何,都可能是有害的,这可能是由于自噬和生酮作用的抑制、过度喂养相关的高血糖和胰岛素需求的增加。含有较低葡萄糖和亮氨酸和较高脂质浓度的EN配方可能通过抑制哺乳动物雷帕霉素(mTOR)途径激活自噬和酮生成。本研究旨在评估新开发的EN配方在危重患者中的临床效果。方法新研制的EN配方于2023年9月上市。新EN产品的组成特点是低碳水化合物,高蛋白质,低亮氨酸含量,高脂质。这项在日本进行的单中心、回顾性队列研究比较了新EN配方和标准配方的临床结果。符合条件的患者是那些在ICU住院至少10天并且需要有创机械通气至少3天的患者。根据患者接受的肠内配方,将患者分为新EN组或标准EN组。主要终点是住院死亡率。次要结局包括胰岛素剂量和电解质水平(钾、磷酸盐和镁)、排便频率和肠缺血发生率。采用倾向评分匹配(PSM)和治疗加权逆概率(IPTW)对基线特征进行调整,然后进行多因素logistic回归分析。结果689例符合条件的患者中,262例被分配到新EN组,427例被分配到标准EN组。经PSM治疗后,每组230例。在IPTW分析中,682例数据完整的患者被纳入加权人群。在PSM和IPTW分析中,新EN组的胰岛素和电解质(钾、磷酸盐和镁)剂量一直较低。新发EN组住院死亡率明显低于标准EN组(25例[10.9%]对48例[20.9%],PSM后P = 0.006, IPTW后P = 0.002)。Logistic回归分析表明,新的EN配方与PSM (OR: 0.46, 95% CI: 0.25-0.80, P = 0.007)和IPTW调整(OR: 0.44, 95% CI: 0.26-0.74, P = 0.002)后住院死亡率的降低显著相关。此外,在两种模型中,较高的肠外热量摄入与死亡率增加显著相关(PSM: OR: 1.10, 95% CI: 1.02-1.19, P = 0.013; IPTW: OR: 1.08, 95% CI: 1.01-1.15, P = 0.020)。结论:本研究表明,新的EN配方与危重通气患者的住院死亡率显著降低相关,突出了其通过优化营养支持改善预后的潜力。
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引用次数: 0
Real-world implementation of a standardized ICU protocol for daytime-restricted enteral nutrition in critically ill adults: A retrospective quality improvement study 危重成人日间限制性肠内营养标准ICU方案的实际实施:一项回顾性质量改善研究
Q3 Nursing Pub Date : 2025-12-29 DOI: 10.1016/j.nutos.2025.100622
Kelsey Russell-Murray , Hassan S. Dashti

Background

Enteral nutrition (EN) delivery is often interrupted in the intensive care unit (ICU), and while continuous 24-hour feeding is standard practice, emerging evidence from circadian biology and pilot trials suggests that daytime-restricted EN may enhance nutritional adequacy and patient outcomes by aligning feeding with biological rhythms.

Methods

This quality improvement study describes a novel, standardized daytime-restricted EN protocol in a community hospital ICU and retrospectively evaluate its real-world implementation. The protocol involved a stepwise transition in EN delivery, beginning with continuous trophic feeding (acute/initial phase), followed by daytime-restricted 12-hour cyclic feeding (anabolic recovery phase), and advancing to intermittent daytime-restricted feeding (chronic recovery phase). A convenience sample of 22 adult ICU patients (12 received continuous 24-hour EN; 10 with the daytime-restricted EN protocol) was analyzed. Clinical data were extracted from electronic medical records, including EN infusion rates, duration, and interruptions.

Results

Patients in the daytime-restricted group received EN at higher infusion rates (median 87.5 vs. 40.0 mL/hr), over fewer hours per day (11.0 vs. 14.5 hours), experienced fewer interruptions (1.0 vs. 9.5 hours/day), and received a greater percentage of their prescribed nutritional volume (90.0% vs. 57.5%) compared to the continuous group (all P value < 0.05). Vomiting was more frequently reported in the daytime-restricted group, while constipation was more common in the continuous group, though these differences were not statistically significant.

Conclusion

This preliminary evaluation supports the feasibility of implementing a daytime-restricted EN protocol in an adult ICU and suggests potential advantages in delivery consistency and nutritional adequacy. To support broader implementation, larger prospective studies across broader ICU populations are necessary.
背景肠内营养(EN)的输送在重症监护室(ICU)经常中断,虽然24小时连续喂养是标准做法,但昼夜生物学和试点试验的新证据表明,白天限制肠内营养可以通过使喂养与生物节律相一致来提高营养充足性和患者预后。方法:本质量改进研究描述了一种新的、标准化的日间限制的社区医院ICU EN方案,并回顾性评估其在现实世界中的实施情况。该方案涉及EN分娩的逐步过渡,从连续营养喂养(急性/初始阶段)开始,随后是白天限制的12小时循环喂养(合成代谢恢复阶段),并推进到间歇性白天限制喂养(慢性恢复期)。选取便利样本22例成人ICU患者(12例接受连续24小时EN治疗,10例接受日间限制EN治疗)进行分析。从电子病历中提取临床数据,包括EN输注速率、持续时间和中断。结果与连续组相比,日间限制组患者以更高的输注速率(中位数87.5 mL/hr vs. 40.0 mL/hr),每天的输注时间更短(11.0小时vs. 14.5小时),中断时间更少(1.0小时vs. 9.5小时/天),并且获得了更高的规定营养体积百分比(90.0% vs. 57.5%)(均P值<; 0.05)。在白天限制组中,呕吐更频繁,而便秘在连续组中更常见,尽管这些差异没有统计学意义。结论该初步评价支持在成人ICU实施日间限制EN方案的可行性,并提示在分娩一致性和营养充足性方面的潜在优势。为了支持更广泛的实施,有必要在更广泛的ICU人群中进行更大规模的前瞻性研究。
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引用次数: 0
Cachexia, sarcopenia, malnutrition and their impact on survival, treatment toxicities, and quality of life in locally advanced cervical cancer patients undergoing concomitant chemoradiotherapy: A scoping review 恶病质、肌肉减少、营养不良及其对局部晚期宫颈癌患者同期放化疗的生存、治疗毒性和生活质量的影响:范围综述
Q3 Nursing Pub Date : 2025-12-27 DOI: 10.1016/j.nutos.2025.100620
Canio Martinelli , Alfredo Ercoli , Luigi Alfano , Francesca Pentimalli , Giulio Mazzarotti , Giacomo Ferrantelli , Antonino De Lorenzo , Teresa Esposito , Antonio Giordano , Salvatore Cortellino

Background

Concurrent chemoradiotherapy for locally advanced cervical cancer (LACC) must be completed within 56 days, with each added day increasing recurrence risk by 1%. Sarcopenia, malnutrition, and cachexia affect 20–60% of patients, yet guidelines do not recommend routine screening, and their independent associations with outcomes remain unmapped.

Methods

We searched MEDLINE, Scopus, Web of Science, and Cochrane (1995–2025) for studies reporting cachexia, malnutrition, or sarcopenia with survival, toxicity, treatment completion, or quality of life in LACC patients receiving chemoradiotherapy. Two reviewers screened records, extracted data, and assessed bias using QUIPS.

Results

Twenty-three studies (4,352 women; cohorts 41–391) used heterogeneous definitions. Malnutrition was assessed in 17 studies, sarcopenia in 15, and cachexia in 2. Malnutrition showed 1.5- to 3.7-fold higher mortality. Chemotherapy-defined sarcopenia predicted survival in 5 of 11 assessments (HR 1.75–3.60); sarcopenic obesity carried HR 2.65. On-treatment body-composition loss showed strongest effects: ≥7–10% skeletal-muscle decline (HR 6.02) and ≥15% intermuscular fat loss (HR 8.52) predicted higher mortality. Grade ≥3 toxicity and treatment interruption were 1.2- to 2.5-fold more frequent in malnourished or sarcopenic women, increasing to 3–5-fold with multiple unfavorable body-composition features. Quality-of-life scores declined 11% during treatment. Seventeen studies had high bias risk from attrition and inadequate confounder control.

Conclusions

Malnutrition, sarcopenia, and cachexia correlate with poor survival and treatment tolerance in LACC chemoradiotherapy; on-treatment muscle loss shows strongest prognostic value. Screening at baseline and muscle quantification on chemotherapy can identify high-risk patients. Consensus definitions, prospective validation, and multimodal prehabilitation trials are needed before implementation.
背景:局部晚期宫颈癌(LACC)的同步放化疗必须在56天内完成,每增加一天复发风险增加1%。肌肉减少症、营养不良和恶病质影响20-60%的患者,但指南不建议进行常规筛查,其与预后的独立关联仍未明确。方法:我们检索MEDLINE、Scopus、Web of Science和Cochrane(1995-2025),以获取关于接受放化疗的LACC患者恶病质、营养不良或肌肉减少症对生存率、毒性、治疗完成度或生活质量影响的研究。两位审稿人筛选记录,提取数据,并使用QUIPS评估偏倚。结果23项研究(4352名女性,41-391组)采用异质定义。17项研究评估了营养不良,15项研究评估了肌肉减少症,2项研究评估了恶病质。营养不良的死亡率高出1.5至3.7倍。化疗定义的肌肉减少症在11项评估中的5项中预测生存(HR 1.75-3.60);肌肉减少型肥胖的HR为2.65。治疗期间体组成损失表现出最强的影响:≥7-10%的骨骼肌下降(HR 6.02)和≥15%的肌间脂肪损失(HR 8.52)预示着更高的死亡率。在营养不良或肌肉减少的女性中,≥3级毒性和治疗中断的频率是1.2- 2.5倍,在多种不利的身体组成特征下增加到3 - 5倍。在治疗期间,生活质量得分下降了11%。有17项研究由于流失和混杂因素控制不足而存在高偏倚风险。结论营养不良、肌肉减少和恶病质与LACC放化疗的生存率和治疗耐受性差有关;在治疗过程中肌肉损失表现出最强的预后价值。基线筛查和化疗时的肌肉量化可以识别高危患者。在实施前需要共识定义、前瞻性验证和多模式康复试验。
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引用次数: 0
Corrigendum to “Effectiveness of omega-3 supplementation in reducing the degree of steatotic liver disease associated with metabolic dysfunction in adults” [Clinical Nutrition Open Science 64 (2025) 255–265] “omega-3补充剂在降低成人与代谢功能障碍相关的脂肪变性肝病程度方面的有效性”的更正[临床营养开放科学64 (2025)255-265]
Q3 Nursing Pub Date : 2025-12-26 DOI: 10.1016/j.nutos.2025.11.011
María Dolores Mondéjar Barrios , Karem Justhin Rodas Trujillo , Juana Olga Espíritu Aguirre , Matilde Anais Matos Inga , Sandra Lisseth Mori Díaz , Luis Alberto Cabanillas Chirinos
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引用次数: 0
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Clinical Nutrition Open Science
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