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1.
Hypoenergetic feeding does not improve outcomes in critically ill patients with premorbid obesity: a post hoc analysis of a randomized controlled trial.
Charles, EJ, Kane, WJ, Willcutts, KF, O'Donnell, KB, Petroze, RT, Sawyer, RG
Nutrition research (New York, N.Y.). 2020;:71-77
Abstract
Optimal energy goals for adult, obese critically ill surgical patients are unclear. To date, there has been little data comparing feeding regimens for obese and non-obese critically ill surgical patients and the effect on outcomes. The objective was to compare the effect of hypoenergetic and euenergetic feeding goals in critically ill obese patients on outcomes, including infection, intensive care unit length of stay, and mortality. We hypothesized that hypoenergetic feeding of patients with premorbid obesity (body mass index ≥ 30 kg•m-2) during critical illness does not affect clinical outcomes. Post hoc analyses were performed on critically ill surgical patients enrolled in a randomized controlled trial. Patients were randomized to receive 25-30 kcal•kg-1•d-1 (105-126 kJ.kg-1•d-1, euenergetic) or 12.5-15 kcal•kg-1•d-1 (52-63 kJ.kg-1 •d-1, hypoenergetic), with equal protein allocation (1.5 g•kg-1•d-1). The effect of feeding regimen on outcomes in obese and nonobese patients were assessed. Of the 83 patients, 30 (36.1%) were obese (body mass index ≥ 30 kg•m-2). Average energy intake differed based on feeding regimen (hypoenergetic: 982±61 vs euenergetic: 1338±92 kcal•d-1, P = .02). Comparing obese and nonobese patients, there was no difference in the percentage acquiring an infection (66.7% [20/30] vs 77.4% [41/53], P = .29), intensive care unit length of stay (16.4±3.7 vs 14.3±0.9 days, P = .39), or mortality (10% [3/30] vs 7.6% [4/53], P = .7). Within the subset of obese patients, the percentage acquiring an infection (hypoenergetic: 78.9% [15/19] vs euenergetic: 45.5% [5/11], P = .11) was not affected by the feeding regimen. Within the subset of nonobese patients, there was a trend toward more infections in the euenergetic group (hypoenergetic: 63.6% [14/22] vs euenergetic: 87.1% [27/31], P = .05). Hypoenergetic feeding does not appear to affect clinical outcomes positively or negatively in critically ill patients with premorbid obesity.
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Optimized calorie and high protein intake versus recommended caloric-protein intake in critically ill patients: a prospective, randomized, controlled phase II clinical trial.
Azevedo, JRA, Lima, HCM, Montenegro, WS, Souza, SCC, Nogueira, IROM, Silva, MM, Muniz, NA
Revista Brasileira de terapia intensiva. 2019;(2):171-179
Abstract
OBJECTIVE To evaluate differences in outcomes for an optimized calorie and high protein nutrition therapy versus standard nutrition care in critically ill adult patients. METHODS We randomized patients expected to stay in the intensive care unit for at least 3 days. In the optimized calorie and high protein nutrition group, caloric intake was determined by indirect calorimetry, and protein intake was established at 2.0 to 2.2g/kg/day. The control group received 25kcal/kg/day of calories and 1.4 to 1.5g/kg/day protein. The primary outcome was the physical component summary score obtained at 3 and 6 months. Secondary outcomes included handgrip strength at intensive care unit discharge, duration of mechanical ventilation and hospital mortality. RESULTS In total, 120 patients were included in the analysis. There was no significant difference between the two groups in calories received. However, the amount of protein received by the optimized calorie and high protein nutrition group was significantly higher compared with the control group. The physical component summary score at 3 and 6 months did not differ between the two groups nor did secondary outcomes. However, after adjusting for covariates, a negative delta protein (protein received minus predetermined protein requirement) was associated with a lower physical component summary score at 3 and 6 months postrandomization. CONCLUSION In this study optimized calorie and high protein strategy did not appear to improve physical quality of life compared with standard nutrition care. However, after adjusting for covariates, a negative delta protein was associated with a lower physical component summary score at 3 and 6 months postrandomization. This association exists independently of the method of calculation of protein target.
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Nutritional Support in Postcardiotomy Shock Extracorporeal Membrane Oxygenation Patients: A Prospective, Observational Study.
Hunt, MF, Pierre, AS, Zhou, X, Lui, C, Lo, BD, Brown, PM, Whitman, GJ, Choi, CW
The Journal of surgical research. 2019;:257-264
Abstract
BACKGROUND Despite the 6000 patients treated with extracorporeal membrane oxygenation (ECMO) annually, there is a paucity of data regarding the nutritional management of these patients. MATERIALS AND METHODS We performed a prospective, observational study of nutrition in postcardiotomy shock patients at our institution. Over a 3.5-year study period, we identified 50 ECMO patients and 225 non-ECMO patients. We identified type, amount, duration, and disruption of nutritional delivery by cohort. The primary outcome was percent of caloric goal met, and secondary outcome was gastrointestinal complications. RESULTS ECMO patients met less of their caloric (29% versus 40%, P = 0.017) and protein goals (34% versus 55%, P < 0.001) compared with non-ECMO patients. Tube feeds were administered more slowly (26 versus 37 mL/h, P < 0.001) and held for longer (8.3 versus 4.5 h/d, P < 0.001) in ECMO patients because of procedures (60%) and high-dose pressors (20% versus 7%, P < 0.001). Multivariate analysis demonstrated that ECMO decreased caloric intake by 14%, with no detected increased risk of gastrointestinal complications. CONCLUSIONS -ECMO patients received significantly less nutrition support compared with a non-ECMO population. Tube feed hold deficits could potentially be avoided by utilizing postpyloric tubes to feed through procedures, by eliminating holds for vasopressors/inotropes in hemodynamically stable patients, or by establishing volume-based feeding protocols. Further clinical studies are needed to establish efficacy of these interventions and to understand the impact of nutrition on outcomes in ECMO patients.
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Randomised controlled trial of early prophylactic feeding vs standard care in patients with head and neck cancer.
Brown, TE, Banks, MD, Hughes, BGM, Lin, CY, Kenny, LM, Bauer, JD
British journal of cancer. 2017;(1):15-24
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Abstract
BACKGROUND Weight loss remains significant in patients with head and neck cancer, despite prophylactic gastrostomy and intensive dietary counseling. The aim of this study was to improve outcomes utilising an early nutrition intervention. METHODS Patients with head and neck cancer at a tertiary hospital in Australia referred for prophylactic gastrostomy prior to curative intent treatment were eligible for this single centre randomised controlled trial. Exclusions included severe malnutrition or dysphagia. Patients were assigned following computer-generated randomisation sequence with allocation concealment to either intervention or standard care. The intervention group commenced supplementary tube feeding immediately following tube placement. Primary outcome measure was percentage weight loss at three months post treatment. RESULTS Recruitment completed June 2015 with 70 patients randomised to standard care (66 complete cases) and 61 to intervention (56 complete cases). Following intention-to-treat analysis, linear regression found no effect of the intervention on weight loss (10.9±6.6% standard care vs 10.8±5.6% intervention, P=0.930) and this remained non-significant on multivariable analysis (P=0.624). No other differences were found for quality of life or clinical outcomes. No serious adverse events were reported. CONCLUSIONS The early intervention did not improve outcomes, but poor adherence to nutrition recommendations impacted on potential outcomes.
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Energy intake and sources of nutritional support in patients with head and neck cancer--a randomised longitudinal study.
Silander, E, Jacobsson, I, Bertéus-Forslund, H, Hammerlid, E
European journal of clinical nutrition. 2013;(1):47-52
Abstract
BACKGROUND/OBJECTIVES Malnutrition decreases the cancer patient's ability to manage treatment, affects quality of life and survival, and is common among head and neck (HN) cancer patients due to the tumour location and the treatment received. In this study, advanced HN cancer patients were included and followed during 2 years in order to measure their energy intake, choice of energy sources and to assess problems with dysphagia. The main purpose was to explore when and for how long the patients had dysphagia and lost weight due to insufficient intake and if having a PEG (percutaneous endoscopic gastrostomy) in place for enteral nutrition made a difference. SUBJECTS/METHODS One hundred thirty-four patients were included and randomised to either a prophylactic PEG for early enteral feeding or nutritional care according to clinical praxis. At seven time points weight, dysphagia and energy intake (assessed as oral, nutritional supplements, enteral and parenteral) were measured. RESULTS Both groups lost weight the first six months due to insufficient energy intake and used enteral nutrition as their main intake source; no significant differences between groups were found. Problems with dysphagia were vast during the 6 months. At the 6-, 12- and 24-month follow-ups both groups reached estimated energy requirements and weight loss ceased. Oral intake was the major energy source after 1 year. CONCLUSIONS HN cancer patients need nutritional support and enteral feeding for a long time period during and after treatment due to insufficient energy intake. A prophylactic PEG did not significantly improve the enteral intake probably due to treatment side effects.
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Effectiveness of oral nutritional supplementation for older women after a fracture: rationale, design and study of the feasibility of a randomized controlled study.
Cameron, ID, Kurrle, SE, Uy, C, Lockwood, KA, Au, L, Schaafsma, FG
BMC geriatrics. 2011;:32
Abstract
BACKGROUND Malnutrition is a problem for many older people recovering from a hip and other major fractures. Oral supplementation with high calorie high protein nutrients is a simple intervention that may help older people with fractures to improve their recovery in terms of rehabilitation time, length of hospital stay and mortality. This paper reports a pilot study to test the feasibility of a trial initiated in a hospital setting with an oral supplement to older people with recent fractures. METHOD A randomized controlled trial with 44 undernourished participants admitted to a hospital following a fracture. The intervention group (n = 23) received a high calorie high protein supplement for forty days in addition to their diet of choice. The control group (n = 21) received high protein milk during their hospital stay in addition to their diet of choice and their usual diet when discharged from hospital. RESULTS All participants were women and their mean age was 85.3 (± 6.1) years. Twenty nine (65%) participants had a hip fracture. At baseline no differences were measured between the two groups regarding their nutritional status, their cognitive ability or their abilities in activities of daily living. There were no significant differences between the intervention and control group with reference to nutritional or functional parameters at 40 day and 4 month follow-ups. Median length of stay in hospital was 18.0 days, with 12 participants being readmitted for a median of 7.0 days. CONCLUSION It is feasible to perform a randomised trial in a hospital and community setting to test the effect of an oral high energy high protein supplement for older people. Due to the limited number of participants and incomplete adherence with use of the supplements no conclusion can be drawn about the efficacy or effectiveness of this intervention.
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[Application of different nutrition therapies in pregnancy with abnormal glucose metabolism].
Ma, WJ, Qi, BH, Zhang, YJ, Huang, ZH, Xiao, BX, Li, YH, Yu, W, Zhu, HL
Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]. 2011;(5):426-9
Abstract
OBJECTIVE To explore the effect of different nutrition therapies on abnormal glucose metabolism during pregnancy and pregnancy outcomes. METHODS The 83 cases of pregnant women with abnormal glucose metabolism who came to nutrition clinic were randomly divided into two groups before 30 weeks pregnancy: 42 cases in traditional food exchange serving group (FES) and 41 cases in food exchange serving based on glycemic load group (FES + GL). Traditional food exchange serving and food exchange serving based on glycemic load were used as the different nutrition therapies for two groups respectively until the time of delivery. The influence of two nutrition therapies on the blood glucose and pregnancy outcomes were observed. RESULTS The daily food glucose load (GL) after nutrition therapy in the FES + GL group (145.9 ± 26.3) were significantly decreased than that of the FES group (179.9 ± 28.9, t = 5.602, P < 0.01). Fasting plasma glucose (FPG) and 2 h postprandial glucose (2 h PG) ((4.63 ± 0.97) and (6.15 ± 1.07) mmol/L, respectively) after nutrition therapy in the FES + GL group were significantly lower than that in pre-nutrition therapy ((4.96 ± 0.81) and (9.13 ± 1.61) mmol/L, t = 2.237, 11.202, respectively, all P values < 0.05). The 2 h PG in the FES + GL group ((6.15 ± 1.07) mmol/L) after nutrition therapy was significantly lower than that of the FES group ((6.86 ± 1.26) mmol/L, t = 2.760, P < 0.05). 19.51% (8/41) of the total incidence of complications in the FES + GL group was lower than that (11/42, 26.19%) in the FES group, but the difference was not significant (χ² = 0.524, P > 0.05). CONCLUSION FES based on GL was much easier to reduce blood glucose compared with FES. Two nutrition therapies can improve maternal and neonatal outcomes in pregnant women with abnormal glucose metabolism.
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Effect of a vitamin/mineral supplement on children and adults with autism.
Adams, JB, Audhya, T, McDonough-Means, S, Rubin, RA, Quig, D, Geis, E, Gehn, E, Loresto, M, Mitchell, J, Atwood, S, et al
BMC pediatrics. 2011;:111
Abstract
BACKGROUND Vitamin/mineral supplements are among the most commonly used treatments for autism, but the research on their use for treating autism has been limited. METHOD This study is a randomized, double-blind, placebo-controlled three month vitamin/mineral treatment study. The study involved 141 children and adults with autism, and pre and post symptoms of autism were assessed. None of the participants had taken a vitamin/mineral supplement in the two months prior to the start of the study. For a subset of the participants (53 children ages 5-16) pre and post measurements of nutritional and metabolic status were also conducted. RESULTS The vitamin/mineral supplement was generally well-tolerated, and individually titrated to optimum benefit. Levels of many vitamins, minerals, and biomarkers improved/increased showing good compliance and absorption. Statistically significant improvements in metabolic status were many including: total sulfate (+17%, p = 0.001), S-adenosylmethionine (SAM; +6%, p = 0.003), reduced glutathione (+17%, p = 0.0008), ratio of oxidized glutathione to reduced glutathione (GSSG:GSH; -27%, p = 0.002), nitrotyrosine (-29%, p = 0.004), ATP (+25%, p = 0.000001), NADH (+28%, p = 0.0002), and NADPH (+30%, p = 0.001). Most of these metabolic biomarkers improved to normal or near-normal levels.The supplement group had significantly greater improvements than the placebo group on the Parental Global Impressions-Revised (PGI-R, Average Change, p = 0.008), and on the subscores for Hyperactivity (p = 0.003), Tantrumming (p = 0.009), Overall (p = 0.02), and Receptive Language (p = 0.03). For the other three assessment tools the difference between treatment group and placebo group was not statistically significant.Regression analysis revealed that the degree of improvement on the Average Change of the PGI-R was strongly associated with several biomarkers (adj. R2 = 0.61, p < 0.0005) with the initial levels of biotin and vitamin K being the most significant (p < 0.05); both biotin and vitamin K are made by beneficial intestinal flora. CONCLUSIONS Oral vitamin/mineral supplementation is beneficial in improving the nutritional and metabolic status of children with autism, including improvements in methylation, glutathione, oxidative stress, sulfation, ATP, NADH, and NADPH. The supplement group had significantly greater improvements than did the placebo group on the PGI-R Average Change. This suggests that a vitamin/mineral supplement is a reasonable adjunct therapy to consider for most children and adults with autism. CLINICAL TRIAL REGISTRATION NUMBER NCT01225198.
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Study protocol: cost-effectiveness of transmural nutritional support in malnourished elderly patients in comparison with usual care.
Neelemaat, F, Thijs, A, Seidell, JC, Bosmans, JE, van Bokhorst-de van der Schueren, MA
Nutrition journal. 2010;:6
Abstract
BACKGROUND Malnutrition is a common consequence of disease in older patients. Both in hospital setting and in community setting oral nutritional support has proven to be effective. However, cost-effectiveness studies are scarce. Therefore, the aim of our study is to investigate the effectiveness and cost-effectiveness of transmural nutritional support in malnourished elderly patients, starting at hospital admission until three months after discharge. METHODS This study is a randomized controlled trial. Patients are included at hospital admission and followed until three months after discharge. Patients are eligible to be included when they are > or = 60 years old and malnourished according to the following objective standards: Body Mass Index (BMI in kg/m2) < 20 and/or > or = 5% unintentional weight loss in the previous month and/or > or = 10% unintentional weight loss in the previous six months. We will compare usual nutritional care with transmural nutritional support (energy and protein enriched diet, two additional servings of an oral nutritional supplement, vitamin D and calcium supplementation, and consultations by a dietitian). Each study arm will consist of 100 patients. The primary outcome parameters will be changes in activities of daily living (determined as functional limitations and physical activity) between intervention and control group. Secondary outcomes will be changes in body weight, body composition, quality of life, and muscle strength. An economic evaluation from a societal perspective will be conducted alongside the randomised trial to evaluate the cost-effectiveness of the intervention in comparison with usual care. CONCLUSION In this randomized controlled trial we will evaluate the effect of transmural nutritional support in malnourished elderly patients after hospital discharge, compared to usual care. Primary endpoints of the study are changes in activities of daily living, body weight, body composition, quality of life, and muscle strength. An economic evaluation will be performed to evaluate the cost-effectiveness of the intervention in comparison with usual care. TRIAL REGISTRATION Netherlands Trial Register (ISRCTN29617677, registered 14-Sep-2005).
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Body composition in older acute stroke patients after treatment with individualized, nutritional supplementation while in hospital.
Ha, L, Hauge, T, Iversen, PO
BMC geriatrics. 2010;:75
Abstract
BACKGROUND Individualized, nutritional support reduced undernutrition among older stroke patients and improved quality of life in our recent randomized, controlled trial. Weight control thus seems to be important after stroke, and methods for monitoring nutritional status need to be simple and non-invasive. Here we aimed to assess if the nutritional intervention altered body composition in men and women in this study cohort, and also to examine the correlation between the methods for assessing body-, fat- and fat-free mass. METHODS Acute stroke patients > 65 years at nutritional risk were randomized to either individualized, nutritional treatment with energy- and protein rich supplementation (intervention, n = 58) or routine, nutritional care (control, n = 66) while in hospital. Body composition was assessed with anthropometry and bioelectrical impedance. The follow-up period was three months. RESULTS During the first week while in hospital, weight loss was smaller in the intervention group compared with the controls (P = 0.013). After three months weight- and fat loss were significant in both men and women. Whereas no significant differences were found in changes in body composition between the male study groups, in the women both weight loss (P = 0.022) and fat loss (P = 0.005) was smaller in the intervention group compared with the controls. A high correlation (r = 0.87) between mid upper arm circumference (MUAC) and body mass index (BMI) was found. CONCLUSIONS Individualized nutritional support to older stroke patients in hospital was beneficial for maintaining an adequate body mass and body composition the first week and seemed to have a preventive effect on fat loss among women, but not among men after three months. Measurement of MUAC may be used in the assessment of nutritional status when BMI cannot be obtained. TRIAL REGISTRATION This trial is registered with ClinicalTrials.gov, number NCT00163007.