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A randomized-controlled trial of arginine infusion in severe sepsis on microcirculation and metabolism.
Luiking, YC, Poeze, M, Deutz, NE
Clinical nutrition (Edinburgh, Scotland). 2020;(6):1764-1773
Abstract
BACKGROUND & AIMS Sepsis is hypothesized as an arginine deficient state, with lack of nitric oxide (NO) for adequate microcirculation and local perfusion. This study aimed to investigate if prolonged (72-h) intravenous l-arginine administration in sepsis patients improves microcirculation. Secondly, effects on arginine and protein metabolism, and organ function were studied. METHODS Critically ill patients with a diagnosis of septic shock participated in a long-term (72 h) randomized double-blind placebo-controlled parallel-group study. l-arginine-HCl (1.2 μmol kg-1 min-1; n = 9) or l-alanine (isocaloric control: 2.4 μmol kg-1 min-1; n = 9) was continuously infused. Primary study outcome was microcirculation, assessed as gastric mucosal perfusion by gastric tonometry (Pr-aCO2 gap) and skin perfusion by Laser Doppler flowmetry. Secondary endpoints were whole body (WB) arginine and protein metabolism, organ function and clinical outcomes. We measured global hemodynamics continuously for safety monitoring. Statistical analyses were performed by mixed model for repeated measures with treatment by time interaction as estimate for between-group difference. RESULTS Pr-aCO2 increased only in the l-arginine group (p = 0.006), without a significant between-group difference (p = 0.17). We found no significant differences in skin perfusion parameters. l-arginine infusion resulted in a larger increase of plasma arginine and ornithine concentrations (p < 0.01), WB (endogenous) arginine appearance (p < 0.001), WB NO synthesis (p = 0.027) and WB arginine to urea conversion (p < 0.001) than infusion of l-alanine. We found no effect on global hemodynamics, and protein metabolism by l-arginine infusion. Organ function parameters were unaffected, except for a significant difference between groups in intra-abdominal pressure over time (p = 0.029). CONCLUSIONS Prolonged intravenous l-arginine administration does not improve local perfusion and organ function despite an increase in WB NO synthesis. Administration is safe with regard to global hemodynamics, but the observed increase in Pr-aCO2 and intra-abdominal pressure warrants careful application of l-arginine infusion and further research, especially in the early stage of septic shock.
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Alginate and HM-pectin in sports-drink give rise to intra-gastric gelation in vivo.
Marciani, L, Lopez-Sanchez, P, Pettersson, S, Hoad, C, Abrehart, N, Ahnoff, M, Ström, A
Food & function. 2019;(12):7892-7899
Abstract
The addition of gelling polysaccharides to sport-drinks may provide improved tolerability of drinks with high concentration of digestible carbohydrates (CHO), otherwise known to increase the risk of gastro-intestinal complaints among athletes under prolonged exercise. The physico-chemical properties of a drink containing 14 wt% of digestible CHO (0.7 : 1 fructose and maltodextrin-ratio), 0.2 wt% of HM-pectin/alginate and 0.06 wt%. sodium chloride were examined under in vitro gastric conditions using rheology and large deformation testing. The in vivo gelling behaviour of the drink was studied using magnetic resonance imaging of subjects at rest together with blood glucose measurements. The in vivo results confirm gelation of the test drink, with no gel remaining in the stomach at 60 min and blood glucose values were similar to control. The physico-chemical characterisation of the acidified test drink confirms the formation of a weak gel through which low Mw CHO can diffuse.
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Use of N-acetylcysteine plus simethicone to improve mucosal visibility during upper GI endoscopy: a double-blind, randomized controlled trial.
Monrroy, H, Vargas, JI, Glasinovic, E, Candia, R, Azúa, E, Gálvez, C, Rojas, C, Cabrera, N, Vidaurre, J, Álvarez, N, et al
Gastrointestinal endoscopy. 2018;(4):986-993
Abstract
BACKGROUND AND AIM Upper GI endoscopy (UGE) is essential for the diagnosis of gastrointestinal diseases. Mucus and bubbles may decrease mucosal visibility. The use of mucolytics could improve visualization. Our aim was to determine whether premedication with simethicone or simethicone plus N-acetylcysteine is effective in improving visibility during UGE. METHODS This was a randomized, double-blinded, placebo-controlled trial with 2 control groups: no intervention and water 100 mL (W); and 3 intervention groups: simethicone 200 mg (S); S + N-acetylcysteine (NAC) 500 mg (S+NAC500); and S + NAC 1000 mg (S+NAC1000). The solution was ingested 20 minutes before UGE. Gastric visibility was evaluated in 4 segments with a previously described scale. A score of less than 7 points was defined as adequate visibility (AV). Water volume was used to improve visibility, and adverse reactions were evaluated as a secondary outcome. Multiple group comparison was performed using non-parametric one-way analysis of variance (ANOVA). RESULTS Two hundred thirty patients were included in the study, 68% female, mean age 49 years. The most common indication for UGE was epigastric pain/dyspepsia (33%). AV was more frequent in the S+NAC500 and S+NAC1000 groups (65% and 67%) compared with no intervention (44%, P = .044) and water (41%, P = .022). The gastric total visibility scale (TVS) was significantly better in the S+NAC500 and S+NAC1000 groups compared with water (P = .03 and P = .008). Simethicone was not different from no intervention and water. S+NAC1000 required less water volume to improve visibility. No adverse reactions from the study drugs were observed. CONCLUSIONS Premedication with S+NAC500 and S+NAC1000 improves visibility during UGE. The use of simethicone did not show improvements in gastric visibility. TVS was worse in patients using water alone. (Clinical trial registration number: NCT 01653171.).
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Impact of homogenization of pasteurized human milk on gastric digestion in the preterm infant: A randomized controlled trial.
de Oliveira, SC, Bellanger, A, Ménard, O, Pladys, P, Le Gouar, Y, Henry, G, Dirson, E, Rousseau, F, Carrière, F, Dupont, D, et al
Clinical nutrition ESPEN. 2017;:1-11
Abstract
BACKGROUND & AIMS It has been suggested that homogenization of Holder-pasteurized human milk (PHM) could improve fat absorption and weight gain in preterm infants, but the impact on the PHM digestive kinetics has never been studied. Our objective was to determine the impact of PHM homogenization on gastric digestion in preterm infants. METHODS In a randomized controlled trial, eight hospitalized tube-fed preterm infants were their own control to compare the gastric digestion of PHM and of homogenized PHM (PHHM). PHM was obtained from donors and, for half of it, was homogenized by ultrasonication. Over a six-day sequence, gastric aspirates were collected twice a day, before and 35, 60 or 90 min after the start of PHM or PHHM ingestion. The impact of homogenization on PHM digestive kinetics and disintegration was tested using a general linear mixed model. Results were expressed as means ± SD. RESULTS Homogenization leaded to a six-fold increase in the specific surface (P < 0.01) of lipid droplets. The types of aggregates formed during digestion were different between PHM and PHHM, but the lipid fraction kept its initial structure all over the gastric digestion (native globules in PHM vs. blend of droplets in PHHM). Homogenization increased the gastric lipolysis level (P < 0.01), particularly at 35 and 60 min (22 and 24% higher for PHHM, respectively). Homogenization enhanced the proteolysis of serum albumin (P < 0.05) and reduced the meal emptying rate (P < 0.001, half-time estimated at 30 min for PHM and 38 min for PHHM). The postprandial gastric pH was not affected (4.7 ± 0.9 at 90 min). CONCLUSIONS Homogenization of PHM increased the gastric lipolysis level. This could be a potential strategy to improve fat absorption, and thus growth and development in infants fed with PHM; however, its gastrointestinal tolerance needs to be investigated further. This trial was registered at clinicaltrials.gov as NCT02112331.
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Acute load-dependent effects of oral whey protein on gastric emptying, gut hormone release, glycemia, appetite, and energy intake in healthy men.
Hutchison, AT, Piscitelli, D, Horowitz, M, Jones, KL, Clifton, PM, Standfield, S, Hausken, T, Feinle-Bisset, C, Luscombe-Marsh, ND
The American journal of clinical nutrition. 2015;(6):1574-84
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Abstract
BACKGROUND In healthy individuals, intraduodenal whey protein load-dependently modulates gastrointestinal motor and hormonal functions and suppresses energy intake. The effect of oral whey, particularly the impact of load, has not been evaluated. OBJECTIVE The purpose of this study was to quantify gastric emptying of 30 and 70 g of oral whey protein loads and their relation to gastrointestinal hormone, glycemic, and appetitive responses. DESIGN On 3 separate occasions in a randomized, double-blind order, 18 lean men [mean ± SEM age: 24.8 ± 1.4 y; body mass index (in kg/m(2)): 21.6 ± 0.5] received iso-osmolar, equally palatable drinks (∼450 mL) containing 30 g pure whey protein isolate (L), 70 g pure whey protein isolate (H), or saline (control). Gastric emptying (with the use of 3-dimensional ultrasound), plasma cholecystokinin, glucagon-like peptide 1, glucose-dependent insulinotropic peptide, insulin, glucagon, total amino acids, and blood glucose were measured for 180 min after consumption of the drinks, and energy intake at a buffet-style lunch was quantified. RESULTS Gastric emptying of the L and H drinks was comparable when expressed in kilocalories per minute (L: 2.6 ± 0.2 kcal/min; H: 2.9 ± 0.3 kcal/min) and related between individuals (r = 0.54, P < 0.01). Gastrointestinal hormone, insulin, and glucagon responses to the L and H drinks were comparable until ∼45-60 min after ingestion, after which time the responses became more differentiated. Blood glucose was modestly reduced after the H drink between t = 45 and 150 min when compared with the L drink (all P < 0.05). Energy intake was suppressed by both L and H drinks compared with control (P < 0.05) (control: 1174 ± 91 kcal; L: 1027 ± 81 kcal; and H: 997 ± 71 kcal). CONCLUSION These findings indicate that, in healthy lean men, the rate of gastric emptying of whey protein is independent of load and determines the initial gastrointestinal hormone response. This study was registered at www.anzctr.org.au as 12611000706976.
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Longer oral exposure with modified sham feeding does not slow down gastric emptying of low- and high-energy-dense gastric loads in healthy young men.
Wijlens, AG, Erkner, A, Mars, M, de Graaf, C
The Journal of nutrition. 2015;(2):365-71
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BACKGROUND A long oral exposure to food and a high-energy density of food have been shown to increase satiety feelings. The effect of energy density is predominantly caused by an inhibition of gastric emptying. It is hypothesized that prolonging oral exposure may have an additional effect on this inhibition of gastric emptying. However, little human data are available to support this hypothesis. OBJECTIVE The objective was to assess the effect of the duration of oral exposure to food on gastric emptying rate of gastric loads (GLs) low and high in energy density and on satiety feelings. METHODS Twenty-six healthy men [mean ± SD age: 22 ± 3 y; BMI (in kg/m(2)): 23 ± 1] participated in a randomized crossover trial with 4 treatments and a control. Treatments consisted of either 1- or 8-min modified sham feeding (MSF) of cake, and a GL of either 100 or 700 kcal infused in the stomach via a nasogastric tube (500 mL, 62.5 mL/min). The control consisted of no MSF and a GL of 500 mL of water. Gastric emptying rate was assessed with a (13)C breath test. Breath samples and satiety feelings were collected at fixed time points until 90 min after start of the treatment. RESULTS Gastric emptying rate and satiety feelings were not affected by duration of MSF (P ≥ 0.27). However, the 700-kcal GL treatments slowed gastric emptying [41% lower area under the curve (AUC)] and increased satiety feelings (22-31% higher AUC) compared with the 100-kcal GL treatments (P < 0.001). No interaction between MSF duration and energy density of GL was found (P ≥ 0.44). CONCLUSIONS Higher gastric energy density inhibited gastric emptying and increased satiety feelings in healthy young men. However, prolonging oral exposure to food did not have an additional effect. This study provides more insight in satiety regulation. This trial was registered at trialregister.nl as NTR3601.
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Development of a gastric retentive system as a sustained-release formulation of pranlukast hydrate and its subsequent in vivo verification in human studies.
Sugihara, H, Matsui, Y, Takeuchi, H, Wilding, I, Connor, A, Abe, K, Nishiura, A
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences. 2014;:62-8
Abstract
Pranlukast hydrate was demonstrated in a human site-of-absorption study to have extremely poor absorption properties in the lower gastrointestinal tract. The ratios of AUC0-24 in the distal small bowel and colon compared to stomach delivery were approximately 1/7 and 1/70, respectively. As a consequence, a gastroretentive double-layered tablet formulation (gastric swelling system; GSS), consisting of a swelling layer and a drug release layer, was developed for once-daily dosing. To study the gastric retention of the optimized GSS, an in vivo gamma scintigraphic study was carried out in nine healthy volunteers. The transit profiles demonstrated that the GSS was retained in the stomach for more than 10h. The plasma profile was prolonged, especially following administration after an evening meal. The human data validated the design concept and suggest that GSS could be a promising approach for the development of sustained-release formulation for drugs with a limited absorption window in the upper small bowel.
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Safety and patient satisfaction of early diet after endoscopic submucosal dissection for gastric epithelial neoplasia: a prospective, randomized study.
Kim, S, Cheoi, KS, Lee, HJ, Shim, CN, Chung, HS, Lee, H, Shin, SK, Lee, SK, Lee, YC, Park, JC
Surgical endoscopy. 2014;(4):1321-9
Abstract
BACKGROUND Endoscopic submucosal dissection (ESD) is a standard treatment for gastric neoplasia limited to the mucosa without lymph node metastasis. However, there are neither standardized guidelines nor studies on the best time to start oral intake after ESD. The aim of this study was to compare patient satisfaction, safety, length of hospital stay, and economic feasibility between an early post-ESD diet and the conventional immediate fasting protocol. METHODS A total of 130 patients with 156 gastric epithelial neoplasias who underwent ESD by a single expert endoscopist were consecutively and prospectively enrolled. Enrolled patients were randomized to an early diet group or a control group. The early diet group started meals as a clear liquid diet on day 0, and a soft diet and general diet in sequence on day 1. The fasting group was fasted for 2 days. Patients in both groups underwent second-look endoscopy within 2 days following ESD and follow-up endoscopy after 2 months. RESULTS In the course of the study, ten patients were excluded. The total number of patients in the early diet group and control group was 63 and 57, respectively. Mean age was 62 years (±9.4). There were no significant differences in clinicopathologic conditions or endoscopic results such as procedure time or size of lesions between the two groups. There were no significant differences in abdominal pain score, rate of post-ESD bleeding or healing rate of ESD-induced ulcer between the two groups. However, the early diet protocol led to significantly higher patient satisfaction (p = 0.001), lower hospital costs (p < 0.001), and shorter hospital stay (p < 0.001) than the conventional fasting protocol. CONCLUSIONS An early post-ESD diet protocol provides higher patient satisfaction, is more cost effective, decreases hospital stay, and does not influence complication rates such as post-ESD bleeding, abdominal pain, or ulcer healing compared with the conventional fasting protocol.
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Epidermal growth factor receptor gene polymorphisms and gastric cancer in Iran.
Abediankenari, S, Jeivad, F
Asian Pacific journal of cancer prevention : APJCP. 2013;(5):3187-90
Abstract
BACKGROUND Epidermal growth factor receptor (EGFR) is a transmembrane receptor which contributes to many processes involved in cell survival, proliferation and inhibits apoptosis, that may lead to cancer development. Gastric cancer is one of the most common diseases of digestive system that has low 5-year-survival. The aim of this research was to determine the significance of EGFR tyrosine kinase domain gene polymorphisms in gastric cancer in Iran. MATERIALS AND METHODS In the present study, 83 patients with gastric cancer and 40 normal subjects were investigated for EGFR gene polymorphisms in exons 18-21 by PCR-SSCP. Then, DNA sequencing was conducted for different mobility shift bands. Finally the data were statistically analyzed using the chi-2 test and the SPSSver.16 program. RESULTS Exon 18 of EGFR gene showed three different bands in SSCP pattern and DNA sequencing displayed one mutation. SSCP pattern of Exons 19 and 21 did not show different migration bands. Exon 20 of EGFR gene revealed multiple migrate bands in SSCP pattern. DNA sequencing displayed 2 mutations in this exon: one mutation was caused amino acid change and another mutation was silent. CONCLUSION It may be that EGFR tyrosine kinase gene polymorphisms differ between populations and screening could be useful in gastric cancer patients who might benefit from tyrosine kinase inhibitor therapy.
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Preparation and evaluation of a novel gastric floating alginate/poloxamer inner-porous beads using foam solution.
Yao, H, Yao, H, Zhu, J, Yu, J, Zhang, L
International journal of pharmaceutics. 2012;(1-2):211-9
Abstract
In the present study, a simple and rapid method was developed to prepare a novel kind of inner-porous floating beads. The beads were prepared by dripping the foam solution into CaCl(2) solution using disposable syringe needle, where the foam solution consisting numerous of microbubbles with poloxamer 188 as foaming agents, alginate as foaming stablizer. Foamability and foam stability of different polymer ratios were evaluated. The SEM cross-section pictures of the beads showed that the beads were inner-porous and composed of bubbles with very thin wall bubbles stacked together. The visual observation result and the resultant-weight method confirmed that the floating beads showed good buoyancy, most beads could float in the stomach for more than 6 h. The floating beads release behavior in vitro showed that drug release from the beads in a sustained-release fashion for 10 h. Gamma scintigraphic images and pharmacokinetic studies in vivo showed that the beads can retained in the stomach for over 6 h and can improve the bioavailability of drug with narrow absorption window.