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A randomized trial of sodium alginate prevention of esophagitis in LA-NSCLC receiving chemoradiotherapy: OLCSG1401.
Ninomiya, K, Yokoyama, T, Hotta, K, Oze, I, Katsui, K, Hata, T, Yoshioka, H, Bessho, A, Hosokawa, S, Kuyama, S, et al
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021;(9):5237-5244
Abstract
BACKGROUND Radiation esophagitis is a critical adverse event that needs to be appropriately managed while administering thoracic irradiation. This trial aimed to investigate whether sodium alginate has preventative effects on esophagitis in patients with non-small-cell lung cancer (NSCLC) receiving concurrent chemoradiotherapy (CRT). METHODS Patients with untreated stage III NSCLC who were eligible for concurrent CRT were randomly assigned at a 1:1:1 ratio to receive one of the following treatments: initial or late use of oral sodium alginate (arms A and B) or water as control (arm C). The primary endpoint was the proportion of patients developing G3 or worse esophagitis. RESULTS Overall, 94 patients were randomly assigned between February 2014 and September 2018. The study was prematurely terminated because of slow accrual. The proportions of patients with G3 or worse esophagitis were 12.5%, 9.8%, and 19.4% in arms A, B, and C, respectively. Patients receiving sodium alginate had fewer onsets of G3 esophagitis; however, differences compared with arm C were not significant (A vs. C: p = 0.46; B vs. C: p = 0.28). The rates of grade 3 or worse non-hematologic toxicities besides esophagitis were 29%, 26%, and 43% in arms A, B, and C, respectively. Interestingly, compared with arm C, a low rate of febrile neutropenia was observed in arm A (3.1% vs. 19.4%: p = 0.04). CONCLUSIONS Sodium alginate did not show significant preventative effects on radiation-induced esophagitis in patients with NSCLC. The frequency of CRT-induced febrile neutropenia was lower in the early use sodium alginate arm. TRIAL REGISTRATION ClinicalTrials.gov Identifier Registry number: UMIN000013133.
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Pectin-Alginate Does Not Further Enhance Exogenous Carbohydrate Oxidation in Running.
Barber, JFP, Thomas, J, Narang, B, Hengist, A, Betts, JA, Wallis, GA, Gonzalez, JT
Medicine and science in sports and exercise. 2020;(6):1376-1384
Abstract
PURPOSE Maximizing carbohydrate availability is important for many endurance events. Combining pectin and sodium alginate with ingested maltodextrin-fructose (MAL + FRU + PEC + ALG) has been suggested to enhance carbohydrate delivery via hydrogel formation, but the influence on exogenous carbohydrate oxidation remains unknown. The primary aim of this study was to assess the effects of MAL + FRU + PEC + ALG on exogenous carbohydrate oxidation during exercise compared with a maltodextrin-fructose mixture (MAL + FRU). MAL + FRU has been well established to increase exogenous carbohydrate oxidation during cycling compared with glucose-based carbohydrates (MAL + GLU). However, much evidence focuses on cycling, and direct evidence in running is lacking. Therefore, a secondary aim was to compare exogenous carbohydrate oxidation rates with MAL + FRU versus MAL + GLU during running. METHODS Nine trained runners completed two trials (MAL + FRU and MAL + FRU + PEC + ALG) in a double-blind, randomized crossover design. A subset (n = 7) also completed a MAL + GLU trial to address the secondary aim, and a water trial to establish background expired CO2 enrichment. Participants ran at 60% V˙O2peak for 120 min while ingesting either water only or carbohydrate solutions at a rate of 1.5 g carbohydrate per minute. RESULTS At the end of 120 min of exercise, exogenous carbohydrate oxidation rates were 0.9 (SD 0.5) g·min with MAL + GLU ingestion. MAL + FRU ingestion increased exogenous carbohydrate oxidation rates to 1.1 (SD 0.3) g·min (P = 0.038), with no further increase with MAL + FRU + PEC + ALG ingestion (1.1 (SD 0.3) g·min; P = 1.0). No time-treatment interaction effects were observed for plasma glucose, lactate, insulin, or nonesterified fatty acids, or for ratings of perceived exertion or gastrointestinal symptoms (all, P > 0.05). CONCLUSION To maximize exogenous carbohydrate oxidation during moderate-intensity running, athletes may benefit from consuming glucose(polymer)-fructose mixtures over glucose-based carbohydrates alone, but the addition of pectin and sodium alginate offers no further benefit.
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Duration of adhesion of swallowed alginates to distal oesophageal mucosa: implications for topical therapy of oesophageal diseases.
Sonmez, S, Coyle, C, Sifrim, D, Woodland, P
Alimentary pharmacology & therapeutics. 2020;(3):442-448
Abstract
BACKGROUND We have previously shown, ex vivo, that alginate solutions can have a topical protective effect on oesophageal mucosal biopsies exposed to simulated gastric juice. Oesophageal mucosal impedance can measure the duration of mucosal adherence of ionic solutions since the impedance drops when the solution is present, and rises to baseline as the solution clears. AIM: To investigate the in vivo duration of adhesion of swallowed alginate solution to distal oesophageal mucosa. METHODS We studied 20 healthy volunteers and 10 patients with heartburn. A pH-impedance catheter was inserted, and baseline distal channel oesophageal impedance measured. Healthy volunteers received 10 mL of either sodium alginate (Gaviscon Advance), Gaviscon placebo (no alginate) or viscous slurry (saline mixed with sucralose), given in a randomised, single-blinded order over three visits. Patients received either sodium alginate or placebo on two visits. Initial impedance drop was measured, then 1-minute mean impedance was measured each minute until ≥75% recovery to baseline. RESULTS In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01). In patients, sodium alginate adhered to the oesophageal mucosa for longer than placebo (9.0 (5.4) vs 3.7 (4.1), P < 0.01). CONCLUSIONS Sodium alginate solution adhered to the oesophageal mucosa for significantly longer than placebo or viscous slurry. This demonstrates that alginates could confer a protective benefit due to mucoadhesion and can be a basis for further development of topical protectants and for topical drug delivery in oesophageal disease.
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Randomised clinical trial: the effectiveness of Gaviscon Advance vs non-alginate antacid in suppression of acid pocket and post-prandial reflux in obese individuals after late-night supper.
Deraman, MA, Abdul Hafidz, MI, Lawenko, RM, Ma, ZF, Wong, MS, Coyle, C, Lee, YY
Alimentary pharmacology & therapeutics. 2020;(11):1014-1021
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Abstract
BACKGROUND Late-night supper increases the risk of postprandial reflux from the acid pocket especially in obesity. An alginate-based, raft-forming medication may be useful for obese patients with GERD. AIMS To compare the efficacy of Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid in post-supper suppression of the acid pocket and post-prandial reflux among obese participants. METHODS Participants underwent 48 h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively, and were randomised to single post-supper (10 pm) dose of either Gaviscon Advance or a non-alginate antacid on the second night. Primary outcomes were suppression of median pH of acid pocket and lower oesophagus, measured every 10-minutes post-supper for 1 h. Secondary outcomes were suppression of % time pH < 4 at lower oesophagus and improvement in frequency and visual analogue score (VAS) of regurgitation. RESULTS Of the 81 screened participants, 55 were excluded and 26 (mean age 33.5 years, males 77.8% and BMI 32.8 kg/m2 ) were randomised to Gaviscon Advance (n = 13) or antacid (n = 13). Median pH of the acid pocket but not the lower oesophagus was suppressed with Gaviscon Advance vs antacid (all P < 0.04) Gaviscon Advance but not antacid significantly reduced in % time pH < 4, symptom frequency and VAS on day 2 vs day 1 (all P < 0.05). CONCLUSIONS Among obese individuals, Gaviscon Advance was superior to a non-alginate antacid in post-supper suppression of the acid pocket. (Clinical trial registration unique identifier: NCT03516188).
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Regenerated oxidised cellulose versus calcium alginate in controlling bleeding from malignant breast cancer wounds: randomised control trial study protocol.
Firmino, F, Santos, J, Meira, KC, de Araújo, JL, Júnior, VA, de Gouveia Santos, VLC
Journal of wound care. 2020;(1):52-60
Abstract
OBJECTIVE Malignant wounds due to breast cancer can present with recurrent episodes of bleeding in the tumour tissue. This study will compare the efficacy of a calcium alginate dressing (Biatain, Coloplast A/S, Denmark) and a regenerated oxidised cellulose dressing (Surgicel, Ethicon, LLC, Puerto Rico). PROTOCOL A total of 24 patients with breast cancer and bleeding, malignant wounds will be enrolled in the randomised, controlled, open study, conducted at a hospital specialising in breast cancer treatment and at another hospital specialising in palliative care. Patients over 18 years old, with bleeding and willing to undergo venipuncture for blood collection will be included. All enrolled patients will be randomised for allocation to an experimental group (regenerated oxidised cellulose dressing) or a control group (calcium alginate dressing). The main intervention will consist of the application of the haemostatic product, assessment of digital pressure and estimation of the time required for haemostasis. OUTCOMES Key outcome measures will be the percentage of patients with haemostasis within 20 minutes, observation of haemostasis after three, five and 10 minutes, in addition to recurrence of bleeding and the quantity of product used. DISCUSSION To our knowledge, this is the first study to evaluate the effectiveness of haemostatic products in malignant wounds. This type of wound is poorly explored in the literature and, among its signs and symptoms, bleeding is poorly studied. The completion of this study will provide a more robust rationale for clinical decision-making related to the control of bleeding in malignant breast cancer wounds in the context of evidence-based nursing practices.
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Addition of pectin-alginate to a carbohydrate beverage does not maintain gastrointestinal barrier function during exercise in hot-humid conditions better than carbohydrate ingestion alone.
Flood, TR, Montanari, S, Wicks, M, Blanchard, J, Sharp, H, Taylor, L, Kuennen, MR, Lee, BJ
Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme. 2020;(10):1145-1155
Abstract
The objective of this study was to compare the effects of consuming a 16% maltodextrin+fructose+pectin-alginate (MAL+FRU+PEC+ALG) drink against a nutrient-matched maltodextrin+fructose (MAL+FRU) drink on enterocyte damage and gastrointestinal permeability after cycling in hot and humid conditions. Fourteen recreational cyclists (7 men) completed 3 experimental trials in a randomized placebo-controlled design. Participants cycled for 90 min (45% maximal aerobic capacity) and completed a 15-min time-trial in hot (32 °C) humid (70% relative humidity) conditions. Every 15 min, cyclists consumed 143 mL of either (i) water; (ii) MAL+FRU+PEC+ALG (90 g·h-1 CHO/16% w/v); or (iii) a ratio-matched MAL+FRU drink (90 g·h-1 CHO/16% w/v). Blood was sampled before and after exercise and gastrointestinal (GI) permeability, which was determined by serum measurements of intestinal fatty acid binding protein (I-FABP) and the percent ratio of lactulose (5 g) to rhamnose (2 g) recovered in postexercise urine. Compared with water, I-FABP decreased by 349 ± 67pg·mL-1 with MAL+FRU+PEC+ALG (p = 0.007) and by 427 ± 56 pg·mL-1 with MAL+FRU (p = 0.02). GI permeability was reduced in both the MAL+FRU+PEC+ALG (by 0.019 ± 0.01, p = 0.0003) and MAL+FRU (by 0.014 ± 0.01, p = 0.002) conditions relative to water. In conclusion, both CHO beverages attenuated GI barrier damage to a similar extent relative to water. No metabolic, cardiovascular, thermoregulatory, or performance differences were observed between the CHO beverages. Novelty Consumption of multiple-transportable CHO, with or without hydrogel properties, preserves GI barrier integrity and reduces enterocyte damage during prolonged cycling in hot-humid conditions.
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Addition of an Alginate Hydrogel to a Carbohydrate Beverage Enhances Gastric Emptying.
Sutehall, S, Galloway, SDR, Bosch, A, Pitsiladis, Y
Medicine and science in sports and exercise. 2020;(8):1785-1792
Abstract
PURPOSE This study aimed to examine the effect of altering osmolality or adding sodium alginate and pectin to a concentrated carbohydrate (CHO) beverage on gastric-emptying (GE) rate. METHODS Boluses (500 mL) of three drinks were instilled double blind in eight healthy men while seated, GE was measured using the double sampling method for 90 min, and blood samples were collected regularly. Drinks consisted of glucose and fructose (MON; 1392 mOsmol·kg), maltodextrin and fructose (POLY; 727 mOsmol·kg), and maltodextrin, fructose, sodium alginate, and pectin (ENCAP; 732 mOsmol·kg) with each providing 180 g·L CHO (CHO ratio of 1:0.7 maltodextrin or glucose/fructose). RESULTS Time to empty half of the ingested bolus was faster for ENCAP (21 ± 9 min) than for POLY (37 ± 8 min); both were faster than MON (51 ± 15 min). There were main effects for time and drink in addition to an interaction effect for the volume of test drink remaining in the stomach over the 90 min period, but there were no differences between MON and POLY at any time point. ENCAP had a smaller volume of the test drink in the stomach than MON at 30 min (193 ± 62 vs 323 ± 54 mL), which remained less up to 60 min (93 ± 37 vs 210 ± 88 mL). There was a smaller volume of the drink remaining in the stomach in ENCAP compared with POLY 20 min (242 ± 73 vs 318 ± 47 mL) and 30 min (193 ± 62 vs 304 ± 40 mL) after ingestion. Although there was a main effect of time, there was no effect of drink or an interaction effect on serum glucose, insulin or nonesterified fatty acid concentrations. CONCLUSION The addition of sodium alginate and pectin to a CHO beverage enhances early GE rate but did not affect serum glucose, insulin, or nonesterified fatty acid concentration at rest.
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Efficacy and safety of 0.6% sodium alginate solution in endoscopic submucosal dissection for esophageal and gastric neoplastic lesion: A randomized controlled study.
Uemura, N, Oda, I, Saito, Y, Ono, H, Fujisaki, J, Matsuhashi, N, Ohata, K, Yahagi, N, Yada, T, Satoh, M, et al
Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society. 2019;(4):396-404
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Abstract
OBJECTIVES Sodium alginate (SA) solution has characteristic viscoelasticity. We aimed to determine efficacy and safety of 0.6% SA for submucosal injection during endoscopic submucosal dissection (ESD) in patients with localized neoplastic lesion in the esophageal and gastric mucosa. METHODS We conducted a randomized controlled study at six major hospitals in Japan including 130 patients with endoscopically localized neoplastic lesion in the esophageal and gastric mucosa and eligible for ESD. Patients were randomly assigned to SA or 0.4% sodium hyaluronate (SH) group (control); ESD was performed using a submucosal injection of SA/SH. As a primary outcome measure, non-inferiority of SA against SH was investigated using en bloc complete resection in ESD and formation and maintenance of mucosal elevation upon injection as an efficacy index. Adverse events during the study were evaluated as safety outcome measures. This study was registered with Pharmaceuticals and Medical Devices Agency (clinical trial no. 28-277/2016-18; clinical trial identification no. KP2013-009_C001). RESULTS Efficacy rate of submucosal injection during ESD was 91.7% (55/60) and 88.7% (55/62) in the SA and SH groups, respectively, demonstrating non-inferiority of SA against SH. Adverse events for which a causal relationship with submucosal injection solution could not be eliminated were noted in 8.2% (5/61) and 4.7% (3/64) in the SA and SH groups, respectively, but symptoms disappeared without treatment/after drug administration in both groups. CONCLUSIONS In Japan, 0.4% SH is the only commercially approved formulation for submucosal injection during ESD. The study results may expand submucosal injection solution options in clinical practice.
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Effect of PolyGlycopleX (PGX) Consumption on Blood Lipid Profiles in Healthy, Low CVD Risk Overweight Adults.
Solah, VA, Kerr, DA, Irawati, D, Hunt, W, Meng, X, Gahler, RJ, Fenton, HK, Johnson, SK, James, AP, Wood, S
Nutrients. 2019;(4)
Abstract
Raised blood lipid levels are associated with a risk of a cardiovascular disease (CVD). Moderate reductions in several CVD factors such as total, low-density lipoprotein (LDL) cholesterol and non-high-density lipoprotein (non-HDL) cholesterol concentrations may be more effective in reducing overall risk than a major reduction in just one. A blind, randomised controlled trial was conducted with 120 healthy overweight (BMI 25⁻30) adults aged 25⁻70 years who were non-smokers, not diabetic and of low risk of cardiovascular disease, as assessed by the Framingham risk equation. Participants consumed 4.5 g PolyGlycopleX (PGX) as softgel capsules (PGXS) or 5 g PGX granules (PGXG) or 5 g rice flour (RF) with meals three times a day for 12 weeks. Total, LDL and non-HDL cholesterol were all significantly reduced (-6%, -5% and -3.5%, respectively) post the PGX granule treatment; however, PGX in softgel capsule form did not affect blood lipid profiles. Daily consumption of PGX granules in overweight low CVD risk adults produced lipid changes indicating a CVD preventative benefit.
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Encapsulation of lipids as emulsion-alginate beads reduces food intake: a randomized placebo-controlled cross-over human trial in overweight adults.
Corstens, MN, Troost, FJ, Alleleyn, AME, Klaassen, T, Berton-Carabin, CC, Schroën, K, Masclee, AAM
Nutrition research (New York, N.Y.). 2019;:86-94
Abstract
The objective of this study was to investigate the efficacy of lipid emulsions encapsulated in calcium-alginate beads in reducing food intake and appetite sensations. These emulsion-alginate beads were ingested in a yogurt (active) and compared to an equienergetic yogurt containing nonencapsulated nutrients with comparable sensory properties (control) in a randomized placebo-controlled trial with crossover design. Thirty-three healthy overweight volunteers (mean age: 43 years; body mass index: 27.7 kg/m2; 14 male) received the 2 treatments. Test days started with a standardized small breakfast (t = 0) followed by an active or control yogurt (t = 90 minutes). Appetite sensations and gastrointestinal symptoms were monitored prior to and after consumption of the yogurt, and food intake was measured during ad libitum pasta meal consumption (t = 210 minutes). The hypothesis for this study was that delayed release of encapsulated lipids suppresses appetite sensations and reduces food intake. Food intake was significantly reduced with 51 ± 20 kcal (213 ± 84 kJ) (P = .016) after intake of the active yogurt (770 ± 38 kcal (3222 ± 159 kJ)) compared to the control (821 ± 40 kcal (3435 ± 167 kJ)). The approach that we chose is promising to reduce food intake and could contribute to the development of an easy-to-use product for weight management.