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Early metabolic support for critically ill trauma patients: A prospective randomized controlled trial.
Stolarski, AE, Young, L, Weinberg, J, Kim, J, Lusczek, E, Remick, DG, Bistrian, B, Burke, P
The journal of trauma and acute care surgery. 2022;(2):255-265
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Abstract
BACKGROUND There is a lack of consensus regarding the optimal nutritional support for trauma patients. We hypothesize that early postinjury metabolic support focusing on adequate protein would modify the metabolic signature and alter the inflammatory environment for critically ill trauma patients. METHODS We conducted a prospective randomized controlled pilot trial for adult patients admitted to the surgical intensive care unit following traumatic injury. Patients were randomized to receive early metabolic support (EMS) (peripheral amino acid infusions) or standard of care (enteral nutrition as soon as feasible). Routine laboratory assessments, nitrogen balance, cytokines, and metabolomic analyses were assessed at baseline and day 5 after intervention. RESULTS A total of 42 trauma patients were randomized into well-balanced groups with similar age (32 years), Injury Severity Score (25), and body mass index (27.4 kg/m2). Early metabolic support provided significantly more protein (1.43 g/kg vs. 0.35 g/kg; p < 0.0001) and more calories (12.6 kcal/kg vs. 7.5 g/kg; p = 0.0012) over the first 5 days as compared with the standard of care. Early metabolic support modified protein catabolism and synthesis as demonstrated by a larger median negative nitrogen balance (-16.3 g vs. -5.3 g; p = 0.03) and a unique metabolomic profile at day 5. The biochemical profile of patients who received EMS was defined by greater declines in circulating levels of stress hormone precursors and increased levels of amino acids. The inflammatory response following EMS resulted in a greater decrease in interleukin-1B (p = 0.02) and increase in soluble interleukin-6 receptor (p = 0.01) between baseline and day 5 as compared with the standard of care. The EMS group had a decreased length of stay (15 vs. 22 days) and decreased surgical intensive care unit length of stay (8 vs. 9 days); however, this disappeared after adjustment for Injury Severity Score in this small population. CONCLUSIONS Early metabolic support with amino acid is safe, modifies metabolism, and may downregulate the inflammatory state associated with significant trauma, warranting a larger trial to assess for improved outcomes. LEVEL OF EVIDENCE Therapeutic/Care Management; Level II.
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Tolerance development in cow's milk-allergic infants receiving amino acid-based formula: A randomized controlled trial.
Chatchatee, P, Nowak-Wegrzyn, A, Lange, L, Benjaponpitak, S, Chong, KW, Sangsupawanich, P, van Ampting, MTJ, Oude Nijhuis, MM, Harthoorn, LF, Langford, JE, et al
The Journal of allergy and clinical immunology. 2022;(2):650-658.e5
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BACKGROUND Tolerance development is an important clinical outcome for infants with cow's milk allergy. OBJECTIVE This multicenter, prospective, randomized, double-blind, controlled clinical study (NTR3725) evaluated tolerance development to cow's milk (CM) and safety of an amino acid-based formula (AAF) including synbiotics (AAF-S) comprising prebiotic oligosaccharides (oligofructose, inulin) and probiotic Bifidobacterium breve M-16V in infants with confirmed IgE-mediated CM allergy. METHODS Subjects aged ≤13 months with IgE-mediated CM allergy were randomized to receive AAF-S (n = 80) or AAF (n = 89) for 12 months. Stratification was based on CM skin prick test wheal size and study site. After 12 and 24 months, CM tolerance was evaluated by double-blind, placebo-controlled food challenge. A logistic regression model used the all-subjects randomized data set. RESULTS At baseline, mean ± SD age was 9.36 ± 2.53 months. At 12 and 24 months, respectively, 49% and 62% of subjects were CM tolerant (AAF-S 45% and 64%; AAF 52% and 59%), and not differ significantly between groups. During the 12-month intervention, the number of subjects reporting at least 1 adverse event did not significantly differ between groups; however, fewer subjects required hospitalization due to serious adverse events categorized as infections in the AAF-S versus AAF group (9% vs 20%; P = .036). CONCLUSIONS After 12 and 24 months, CM tolerance was not different between groups and was in line with natural outgrowth. Results suggest that during the intervention, fewer subjects receiving AAF-S required hospitalization due to infections.
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Supplementation with a Natural Source of Amino Acids, Sil-Q1 (Silk Peptide), Enhances Natural Killer Cell Activity: A Redesigned Clinical Trial with a Reduced Supplementation Dose and Minimized Seasonal Effects in a Larger Population.
Cho, JM, Yoo, D, Lee, JY, Oh, MS, Ha, KC, Baek, HI, Lee, SM, Lee, JH, Yoo, HJ
Nutrients. 2021;(9)
Abstract
The aim of this study was to re-validate the changes in natural killer (NK) cell cytotoxicity and cytokines related to T cells after Sil-Q1 (SQ; silk peptide) supplementation in a larger pool of Korean adults with minimized daily dose of SQ and controlling seasonal influence compared to the previous study. A total of 130 subjects were randomly assigned (1:1) to consume either 7.5 g of SQ or placebo for 8 weeks. NK cell cytotoxicity and cytokines were measured at T0 (baseline) and T8 (follow-up). Comparing the NK cell cytotoxicity values at T0 and T8 within each group, the cytotoxicity at all effector cell (E) to target cell (T) ratios of 10:1, 5:1, 2.5:1, and 1.25:1 was significantly increased in the SQ group at T8. Additionally, significant differences in the changed value (Δ, subtract baseline values from follow-up values) comparison between the groups at E:T = 10:1, 5:1, and 2.5:1 were found. As a secondary endpoint, the interleukin (IL)-12 level in the SQ group was significantly increased for 8 weeks, and Δ IL-12 in the SQ group was greater than in the placebo group. In conclusion, the present study showed considerable practical implications of SQ supplementation. Thus, SQ is an effective and safe functional food supplement for enhancing immune function.
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Diet Effects on Cerebrospinal Fluid Amino Acids Levels in Adults with Normal Cognition and Mild Cognitive Impairment.
Russin, KJ, Nair, KS, Montine, TJ, Baker, LD, Craft, S
Journal of Alzheimer's disease : JAD. 2021;(2):843-853
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BACKGROUND Exploration of cerebrospinal fluid (CSF) amino acids and the impact of dietary intake on central levels may provide a comprehensive understanding of the metabolic component of Alzheimer's disease. OBJECTIVE The objective of this exploratory study was to investigate the effects of two diets with varied nutrient compositions on change in CSF amino acids levels in adults with mild cognitive impairment (MCI) and normal cognition (NC). Secondary objectives were to assess the correlations between the change in CSF amino acids and change in Alzheimer's disease biomarkers. METHODS In a randomized, parallel, controlled feeding trial, adults (NC, n = 20; MCI, n = 29) consumed a high saturated fat (SFA)/glycemic index (GI) diet [HIGH] or a low SFA/GI diet [LOW] for 4 weeks. Lumbar punctures were performed at baseline and 4 weeks. RESULTS CSF valine increased and arginine decreased after the HIGH compared to the LOW diet in MCI (ps = 0.03 and 0.04). This pattern was more prominent in MCI versus NC (diet by diagnosis interaction ps = 0.05 and 0.09), as was an increase in isoleucine after the HIGH diet (p = 0.05). Changes in CSF amino acids were correlated with changes in Alzheimer's disease CSF biomarkers Aβ42, total tau, and p-Tau 181, with distinct patterns in the relationships by diet intervention and cognitive status. CONCLUSION Dietary intake affects CSF amino acid levels and the response to diet is differentially affected by cognitive status.
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Effect of amino acid infusion during cesarean delivery on newborn temperature: a randomized controlled trial.
Pokharel, K, Subedi, A, Tripathi, M, Biswas, BK
BMC pregnancy and childbirth. 2021;(1):267
Abstract
BACKGROUND The effect of maternal amino acid (AA) infusion before and during cesarean delivery on neonatal temperature remains unknown. We hypothesized that thermogenic effects of AA metabolism would help maintain body temperature of newborn babies and their mothers. METHODS Seventy-six parturients scheduled for elective singleton term cesarean delivery were equally randomized to receive intravenous 200 ml of AA or placebo approximately 1 h before subarachnoid block (infusion rate:100 ml/h). The primary outcome was the newborn rectal temperature at 0, 5 and 10 min after birth. The secondary outcomes included the maternal rectal temperature at six time-points: T0 = before starting study solution infusion, T1 = 30 min after starting infusion, T2 = one hour after starting infusion, T3 = during spinal block, T4 = half an hour after spinal block, T5 = at the time of birth and T6 = at the end of infusion, as well as maternal thermal discomfort and shivering episodes. RESULTS There were no differences in newborn temperature between the two groups at any of the time-points (intervention-time-interaction effect, P = 0.206). The newborn temperature (mean [95%CI] °C) at birth was 37.5 [37.43-37.66] in the AA and 37.4 [37.34-37.55] in the placebo group. It showed a significant (P < 0.001) downward trend at 5 and 10 min after birth (time effect) in both groups. One neonate in the AA and five in the placebo group were hypothermic (temperature < 36.5 °C) (P = 0.20). There was a significant difference in the maternal temperature at all time points between the two groups (Intervention-time interaction effect, P < 0.001). However, after adjustment for multiplicity, the difference was significant only at T6 (P = 0.001). The mean difference [95%CI] in temperature decline from baseline (T0) till the end of infusion (T6) between the two groups was - 0.39 [- 0.55;- 0.22] °C (P < 0.0001). Six mothers receiving placebo and none receiving AA developed hypothermia (temperature < 36 °C) (P = 0.025). Maternal thermal discomfort and shivering episodes were unaffected by AA therapy. CONCLUSIONS Under the conditions of this study, maternal AA infusion before and during spinal anesthesia for cesarean delivery did not influence the neonatal temperature within 10 min after birth. In addition, the maternal temperature was only maintained at two hours of AA infusion. TRIAL REGISTRATION ClinicalTrials.government, Identifier NCT02575170 . Registered on 10th April, 2015 - Retrospectively registered.
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Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity, and Amino Acid Profiles in Obese Postmenopausal Women: A Randomized, Controlled Clinical Pilot Trial.
Rondanelli, M, Peroni, G, Giacosa, A, Fazia, T, Bernardinelli, L, Naso, M, Faliva, MA, Tartara, A, Gasparri, C, Perna, S
Nutrients. 2021;(2)
Abstract
Rice germ (RG) may be a safe and effective dietary supplement for obesity in menopause, considering its high protein content and considerable amounts of essential amino acids, good fatty acids, and fiber. This pilot randomized, blinded, parallel-group, placebo-controlled pilot trial investigated the effectiveness of 4-weeks RG supplementation (25 g twice a day) on body composition, as primary outcome, measured by Dual Energy X-Ray Absorptiometry (DXA), and metabolic parameters, as secondary outcomes, like amino acid profiles and satiating capacity, in obese postmenopausal women following a tailored hypocaloric diet (25-30% less than daily energy requirements). Twenty-seven women were randomly assigned to the supplemented group (14) or placebo group (13). There was a significant interaction between time and group for body mass index (BMI) (p < 0.0001), waist (p = 0.002) and hip circumferences (p = 0.01), total protein (0.008), albumin (0.005), Homeostasis Model Assessment index score (p = 0.04), glycine (p = 0.002), glutamine (p = 0.004), and histidine (p = 0.007). Haber's means over time showed a clearly greater feeling of satiety for the supplemented compared to the placebo group. These findings indicate that RG supplementation in addition to a tailored diet counterbalanced the metabolic changes typical of menopause, with improvements in BMI, body composition, insulin resistance, amino acid profiles, and satiety.
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Postprandial amino acid availability after intake of intact or hydrolyzed meat protein in a mixed meal in healthy elderly subjects: a randomized, single blind crossover trial.
Agergaard, J, Hansen, ET, van Hall, G, Holm, L
Amino acids. 2021;(6):951-959
Abstract
The absorption of dietary proteins affects the anabolic response, among others protein synthesis. For elderly, optimal amino acid absorption is warranted to preserve the amino acid pool of the body, especially skeletal muscle proteins. Therefore, the aim of this study was to characterize if hydrolyzing meat protein (HMP) would improve the amino acid absorption after ingestion of meat compared to equal amounts of the same meat proteins but present in a different structure; steak or minced meat. With a crossover study design on 12 healthy older adults (> 65 years of age, BMI 18.5-30), the amino acid absorption kinetics were explored by ingesting 0.55 g protein/kg LBM as a mixed meal together with intrinsically [2H5]phenylalanine labeled meat proteins prepared as a STEAK, MINCED meat, or HMP. Plasma [2H5]phenylalanine enrichment as well as AA concentrations were measured by mass spectrometry from blood samples drawn during a 5-h postprandial period. After HMP ingestion, [2H5]phenylalanine was faster absorbed in the initial 2 h compared to STEAK and MINCED. The peak time in AA concentrations was faster in HMP compared to STEAK and MINCED. However, the peak AA concentrations were not different between STEAK, MINCED, and HMP. Although HMP showed to have the fastest initial amino acid appearance in older adults, the peak EAA concentrations were similar after ingesting meal with either STEAK, MINCED, or HMP in the 5-h postprandial period.
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Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial.
Muresanu, DF, Florian, S, Hömberg, V, Matula, C, von Steinbüchel, N, Vos, PE, von Wild, K, Birle, C, Muresanu, I, Slavoaca, D, et al
Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology. 2020;(5):1171-1181
Abstract
INTRODUCTION The objective of this trial was to evaluate the efficacy and safety of Cerebrolysin in treating patients after moderate to severe traumatic brain injury (TBI) as an adjunct to standard care protocols. The trial was designed to investigate the clinical effects of Cerebrolysin in the acute (neuroprotective) stage and during early and long-term recovery as part of a neurorestorative strategy. MATERIALS AND METHODS The study was a phase IIIb/IV single-center, prospective, randomized, double-blind, placebo-controlled clinical trial. Eligible patients with a Glasgow Coma Score (GCS) between 7 and 12 received study medication (50 ml of Cerebrolysin or physiological saline solution per day for 10 days, followed by two additional treatment cycles with 10 ml per day for 10 days) in addition to standard care. We tested ensembles of efficacy criteria for 90, 30, and 10 days after TBI with a priori ordered hypotheses using a multivariate, directional test, to reflect the global status of patients after TBI. RESULTS The study enrolled 142 patients, of which 139 underwent formal analysis (mean age = 47.4, mean admission GCS = 10.4, and mean Baseline Prognostic Risk Score = 2.6). The primary endpoint, a multidimensional ensemble of 13 outcome scales, indicated a "small-to-medium"-sized effect in favor of Cerebrolysin, statistically significant at day 90 (MWcombined = 0.59, 95% CI 0.52 to 0.66, P = 0.0119). Safety and tolerability observations were comparable between treatment groups. CONCLUSION Our trial confirms previous beneficial effects of the multimodal, biological agent Cerebrolysin for overall outcome after moderate to severe TBI, as measured by a multidimensional approach. Study findings must be appraised and aggregated in conjunction with existing literature, as to improve the overall level of insight regarding therapeutic options for TBI patients. The widely used pharmacologic intervention may benefit from a large-scale observational study to map its use and to establish comparative effectiveness in real-world clinical settings.
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Comparable Postprandial Amino Acid and Gastrointestinal Hormone Responses to Beef Steak Cooked Using Different Methods: A Randomised Crossover Trial.
Prodhan, UK, Pundir, S, Chiang, VS, Milan, AM, Barnett, MPG, Smith, GC, Markworth, JF, Knowles, SO, Cameron-Smith, D
Nutrients. 2020;(2)
Abstract
Cooking changes the texture and tenderness of red meat, which may influence its digestibility, circulatory amino acids (AA) and gastrointestinal (GI) hormonal responses in consumers. In a randomised crossover intervention, healthy males (n = 12) consumed a beef steak sandwich, in which the beef was cooked by either a pan-fried (PF) or sous-vide (SV) method. Plasma AA were measured by ultrahigh performance liquid chromatography (UPLC), while plasma GI hormones were measured using a flow cytometric multiplex array. Following meat ingestion, the circulatory concentrations of some of the essential AA (all the branched-chain AA: leucine, isoleucine and valine; and threonine), some of the nonessential AA (glycine, alanine, tyrosine and proline) and some of the nonproteogenic AA (taurine, citrulline and ornithine) were increased from fasting levels by 120 or 180 min (p < 0.05). There were no differences in circulating AA concentrations between cooking methods. Likewise, of the measured GI hormones, glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) concentrations increased from fasting levels after consumption of the steak sandwich (p < 0.05), with no differences between the cooking methods. In the healthy male adults, protein digestion and circulating GI hormone responses to a beef-steak breakfast were unaltered by the different cooking methods.
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The Appetite-Suppressant and GLP-1-Stimulating Effects of Whey Proteins in Obese Subjects are Associated with Increased Circulating Levels of Specific Amino Acids.
Rigamonti, AE, Leoncini, R, De Col, A, Tamini, S, Cicolini, S, Abbruzzese, L, Cella, SG, Sartorio, A
Nutrients. 2020;(3)
Abstract
UNLABELLED The satiating effect of whey proteins depends upon their unique amino acid composition because there is no difference when comparing whey proteins or a mix of amino acids mimicking the amino acid composition of whey proteins. The specific amino acids underlying the satiating effect of whey proteins have not been investigated to date. AIMS AND METHODS The aim of the present study was to evaluate the appetite-suppressant effect of an isocaloric drink containing whey proteins or maltodextrins on appetite (satiety/hunger measured by a visual analogue scale or VAS), anorexigenic gastrointestinal peptides (circulating levels of glucagon-like peptide 1 (GLP-1) and peptide tyrosine tyrosine (PYY)) and amino acids (circulating levels of single, total [TAA] and branched-chain amino acids [BCAA]) in a cohort of obese female subjects (n = 8; age: 18.4 ± 3.1 years; body mass index, BMI: 39.2 ± 4.6 kg/m2). RESULTS Each drink significantly increased satiety and decreased hunger, the effects being more evident with whey proteins than maltodextrins. Similarly, circulating levels of GLP-1, PYY and amino acids (TAA, BCAA and alanine, arginine, asparagine, citrulline, glutamine, hydroxyproline, isoleucine, histidine, leucine, lysine, methionine, ornithine, phenylalanine, proline, serine, threonine, tyrosine, and valine) were significantly higher with whey proteins than maltodextrins. In subjects administered whey proteins (but not maltodextrins), isoleucine, leucine, lysine, methionine, phenylalanine, proline, tyrosine, and valine were significantly correlated with hunger (negatively), satiety, and GLP-1 (positively). CONCLUSIONS Eight specific amino acids (isoleucine, leucine, lysine, methionine, phenylalanine, proline, tyrosine, and valine) were implicated in the appetite-suppressant and GLP-1-stimulating effects of whey proteins, which may be mediated by their binding with nutrient-sensing receptors expressed by L cells within the gastrointestinal wall. The long-term satiating effect of whey proteins and the effectiveness of a supplementation with these amino acids (i.e., as a nutraceutical intervention) administered during body weight reduction programs need to be further investigated.