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Gastroesophageal reflux disease (GERD) is a prevalent global condition, affecting 18.1–27.8% of North Americans and 6.3–18.3% of the Thai population. While proton pump inhibitors (PPIs) are the first-line treatment, only about one-third of patients achieve adequate symptom control. Alginate-based medications in combination with PPIs have shown promise, but the comparative effectiveness of generic versus original alginates remains unexplored. To compare the effectiveness of generic alginate (ONE GERD) versus original alginate (Gaviscon Dual Action Suspension) in combination with PPIs for treating GERD symptoms in patients who failed standard PPI therapy.This multicenter prospective randomized controlled non-inferiority trial included 48 patients who failed standard-dose PPI treatment. Patients were randomized to receive either generic or original alginate four times daily for 28 days. Treatment response was evaluated using the Reflux Disease Questionnaire (RDQ) at days 7 and 28. At day 7, both groups showed identical response rates of 45.83%. By day 28, response rates increased to 54.17% for generic alginate and 70.83% for original alginate ( p  = 0.23). Total RDQ scores and symptom-free rates showed no significant differences between groups at both time points. Adverse event rates were comparable (16.67% vs. 8.33%, p  = 0.66). Analysis of specific symptoms (heartburn, chest pain, and regurgitation) revealed similar improvements in both groups throughout the study period. This study provides evidence supporting the therapeutic equivalence of the generic alginate (ONE GERD) to the original formulation (Gaviscon Dual Action Suspension) in treating symptoms for patients with GERD who have failed PPI therapy. Crucially, the comparable efficacy and safety, coupled with the inherent lower cost of generic medications, suggest significant economic benefits and the potential for wider patient access to effective GERD management. This makes generic alginate a viable and attractive alternative in clinical practice, particularly in resource-limited settings or for patients facing financial constraints, thereby contributing to more equitable healthcare solutions without compromising therapeutic outcomes.

IntroductionPersistent throat symptoms (PTS) are indicators for over 60 000 new patient referrals to NHS secondary care annually. PTS have been attributed to manifestation of gastro-oesophageal reflux disease (GORD) with the hypothesis that gastric refluxate damages and irritates the mucosa of the upper aerodigestive tract. Symptoms of PTS and GORD are commonly treated with proton pump inhibitors (PPIs) or alginates are often, incorrectly, advocated. The Trial of PPIs in Throat Symptoms trial definitively demonstrated that lansoprazole is no more effective than placebo in treating symptoms of PTS, indicating that empirical PPI treatment for PTS should be discouraged. The impact of this is an anticipated increase in prescriptions of alginates for PTS, however, there is a lack of evidence of the efficacy of alginates in treating this condition. Trial of alginates in throat symptoms aims to compare symptomatic response of the symptoms of PTS in liquid alginate (Gaviscon Advance) in comparison to a near matched placebo over an 8-week period to provide definitive evidence of the use of alginates in treating PTS.Methods and analysisThis is a multicentre, pragmatic, double blind, parallel, randomised controlled trial. 250 adults with PTS will be recruited from NHS secondary care sites and randomised to either liquid alginate (Gaviscon Advance) or near matched placebo in a 1:1 ratio. The primary objective is to compare the symptomatic response in patients with PTS to liquid alginate (Gaviscon Advance) compared with placebo using the outcome measure of total Reflux Symptom Index questionnaire score at 8 weeks.Ethics and disseminationFavourable ethical opinion was received from the East Midlands—Leicester South Research Ethics Committee (reference: 22/EM/0205). All participants will provide informed consent prior to any trial specific activity taking place. Results will be disseminated in peer reviewed publications, at national and international conferences, in peer reviewed journals and to participants and the public (using lay language).Trial registration numberISRCTN13949559

Background: This study aimed to compare the effects of a carbohydrate (CHO) hydrogel with (ALG-CP) or without (ALG-C) branched-chain amino acids, and a CHO-only non-hydrogel (CON), on cycling performance. The hydrogels, encapsulated in an alginate matrix, are designed to control CHO release, potentially optimising absorption, increasing substrate utilisation, and reducing gastrointestinal distress as well as carious lesions. Methods: In a randomised, double-blinded, crossover trial, 10 trained male cyclists/triathletes completed three experimental days separated by ~6 days. During the experimental days, participants completed a standardised 2 h cycling bout (EX1), followed by a time-to-exhaustion (TTE) performance test at W75%. Supplements were ingested during EX1. Results: Participants cycled ~8.8 (29.6%) and ~5.4 (29.1%) minutes longer during TTE with ALG-CP compared to ALG-C and CON, respectively. TTE was 65.28 ± 2.8 min with ALG-CP, 56.46 ± 10.92 min with ALG-C, and 59.89 ± 11.89 min with CON. Heart rate (HR) was lower during EX1 with ALG-CP (p = 0.03), and insulin levels increased more significantly during the first 45 min with ALG-CP. Plasma glucose and glucagon levels remained consistent across supplements, although glucagon was higher with ALG-CP before TTE. Post-exercise myoglobin levels were lower with ALG-CP compared to ALG-C (p = 0.02), indicating reduced muscle damage. Conclusions: While ALG-CP improved performance duration compared to ALG-C and CON, the difference did not reach statistical significance. Additionally, there was a lower HR during the cycling session, alongside a significantly lower level of myoglobin with ALG-CP. These findings suggest that ALG-CP may offer advantages in cycling performance and recovery.

The aims of this study were to evaluate the efficacy of magnesium alginate in decreasing functional regurgitation symptoms in infants, and to assess the cost–benefit ratio of magnesium alginate compared to a thickened formula. A multicenter perspective cross-over study was conducted in formula-fed infants with persisting regurgitation, randomly assigned to receive two weeks of a magnesium-alginate-based formulation followed by two weeks of thickened formula, or vice-versa. Infants, exclusively breast-fed, were followed up for two weeks while receiving magnesium alginate. Symptoms of gastroesophageal reflux (GER) were evaluated through the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R). Direct cost of treatments was also calculated. Seventy-two infants completed the study. We found a significant reduction of I-GERQ-R scores over time (F = 55.387; p < 0.001) in all groups with no difference between the sequences of administration (F = 0.268; p = 0.848) in formula-fed infants and between exclusively breast-fed and formula-fed infants receiving magnesium alginate (t = 1.55; p = 0.126). The mean cost savings per infant was € 4.60 (±11.2) in formula-fed infants treated with magnesium alginate compared to thickened formula (t = 2.91, p < 0.0005). Conclusions were that the magnesium-alginate formulation reduces GER symptoms both in formula-fed and breast-fed infants. In formula-fed infants, clinical efficacy is similar to thickened formulas with a slightly lower cost of treatment.

Background/Objectives: Sodium alginate reduces appetite and glycemia, when consumed in water- and sugar-based drinks. But, its effects when added to other commonly consumed beverages have not been reported. Because chocolate milk (CM) is criticized for raising blood glucose more than unflavored milk, the aim of our study was to investigate the effect of adding a strong-gelling sodium alginate to CM on glycemia, insulinemia, appetite and food intake. Subjects/Methods: In a randomized crossover design, 24 men (22.9±0.4 years; 22.5±0.3 kg/m 2 ) were provided with isovolumetric (325 ml) treatments of CM, 1.25% alginate CM, 2.5% alginate CM or 2.5% alginate solution. Sodium alginate had a ratio of 0.78:1 of mannuronic acid (M) to guluronic acid (G) residues, and was block distributed. Treatments were standardized for lactose, sucrose and calcium content, and provided 120 min before an ad libitum pizza meal during which food intake was measured. Appetite and blood glucose and insulin were measured at baseline and at intervals pre- and post-meal. Results: Addition of 2.5% alginate to CM reduced peak glucose concentrations, at 30 min, by an average of 6% and 13% compared with 1.25% alginate CM (95% confidence intervals (CIs): 0.02–1.08; P =0.037) and CM alone (95% CIs: 0.49–1.55; P =0.000) respectively. Insulin peaks at 30 min were lower by 46% after 2.5% alginate CM relative to CM (95% CIs: 3.49–31.78; P =0.009). Pre-meal appetite was attenuated dose dependently by alginate addition to CM; CM with 2.5% alginate reduced mean appetite by an average of 134% compared with CM alone (95% CIs: 8.87–18.98; P =0.000). However, total caloric intake at the pizza meal did not differ among treatments. Conclusions: The addition of a strong-gelling sodium alginate to CM decreases pre-meal glycemia, insulinemia and appetite, but not caloric intake at a meal 2 h later, in healthy adult men.

Endovascular aortic repair (EVAR) is often followed by aneurysm recurrence. Alginate oligosaccharide (AOS) has potential antitumor properties as a natural product while the related mechanisms remain unclear. Toll-like receptor (TLR) signaling is associated with inflammatory activity of aneurysm and may be affected by miR-29b. Thus, inhibitory function of AOS on aneurysms was explored by measuring the important molecules in TLR4 signaling. After EVAR, a total of 248 aortic aneurysm patients were recruited and randomly assigned into two groups: AOS group (AG, oral administration 10-mg AOS daily) and control group (CG, placebo daily). The size of residual aneurysms, aneurysm recurrence, and side effects were investigated. Aneurysm recurrence was determined by Kaplan-Meier analysis. After 2 years, eight and two patients died in the CG and AG, respectively. The sizes of residual aneurysms were significantly larger in the CG than in the AG ( <0.05). The incidence of aneurysm recurrence was also significantly higher in the CG than in the AG ( <0.05). AOS treatment reduced the levels of miR-29b, TLR4, mitogen-activated protein kinase (MAPK), nuclear factor kappa B (NF-kappa B), interleukin 1 (IL-1) beta, and interleukin 6 (IL-6). Overexpression and silence of miR-29b increased and reduced the level of TLR4, phospho-p65 NF-kappa B, phospho-p38 MAPK, IL-1 beta, and IL-6. Spearman's rank correlation analysis shows that the level of miR-29b is positively related to the levels of TLR4, NF-kappa B, IL-1 beta, and IL-6 ( <0.05). Thus, AOS represses aneurysm recurrence by indirectly affecting TLR signaling via miR-29b.

Fibre supplementation can potentially reduce energy intake and contribute to weight loss. The mechanism may be reduced frequency of eating, resulting in reduced food consumption. The objective of this research was to determine the effectiveness of fibre supplementation with PolyGlycopleX® (PGX®), on body weight and composition, frequency of eating and dietary intake in 118 overweight adults. In a three‐arm, parallel, blind, randomised controlled trial participants were randomised to one of three groups; 4.5 g PGX as softgels (PGXS), 5 g PGX granules (PGXG) or 5 g rice flour (RF) control. Prior to supplementation and at 12 weeks, participants captured before and after images of all food and beverages consumed within 4 days using a mobile food record app (mFR). The mFR images were analysed for food group serving sizes and number of eating occasions. In the PGXG group, per-protocol analysis showed there was a significant reduction in waist circumference (2.5 cm; p = 0.003). Subgroup analysis showed that PGXG supplementation at the recommended dose resulted in a reduction in body weight (−1.4 ± 0.10 kg, p < 0.01), body mass index (BMI) reduction (-0.5 ± 0.10, p < 0.01), reduced number of eating occasions (−1.4 ± 1.2, p < 0.01) and a reduced intake of grain food (-1.52 ± 1.84 serves, p = 0.019). PGXG at the recommended dose resulted in a reduction in weight and BMI which was significantly greater than that for RF (p = 0.001). These results demonstrate the potential benefits of PGX fibre in controlling frequency of eating and in weight loss.

Higher fibre intakes are associated with risk reduction for chronic diseases. This study investigated the effects of supplementation with PolyGlycopleX® (PGX), a complexed polysaccharide, on insulin, glucose and lipids in overweight and obese individuals. In this double-blind 12 months study, participants were randomised into three groups: control (rice flour); PGX or psyllium (PSY). Participants followed their usual lifestyle and diet but consumed 5 g of their supplement before meals. Insulin was significantly lower in the PGX and PSY groups compared to control at 3 and 6 months and in the PSY group compared to control at 12 months. Serum glucose was significantly lower in the PGX group at 3 months compared to control. Total cholesterol was significantly lower in the PGX and PSY groups compared to control at 3 and 6 months. High density lipoprotein (HDL) cholesterol was significantly increased in the PGX group compared to control at 12 months. low density lipoprotein (LDL) cholesterol was significantly lower in the PGX group at 3 and 6 months compared to control and in the PSY group at 3 months compared to control. A simple strategy of fibre supplementation may offer an effective solution to glucose, insulin and lipid management without the need for other nutrient modification.

The effect of consumption of PolyGlycopleX® (PGX®) was compared to wheat dextrin (WD) in combination with a standard meal, on postprandial satiety and glycaemia in a double-blind, randomised crossover trial, of 14 healthy subjects trained as a satiety panel. At each of six two-hour satiety sessions, subjects consumed one of three different test meals on two separate occasions. The test meals were: a standard meal plus 5 g PGX; a standard meal plus 4.5 g of PGX as softgels; and a standard meal plus 5 g of WD. Subjects recorded fullness using a labelled magnitude scale at 0, 15, 30, 45, 60, 90, and 120 min and the total area under the curve (AUC), mean fullness vs. time was calculated. The meals with PGX (in granular and softgel form) gave higher satiety (AUC) (477 ± 121 and 454 ± 242 cm·min), than the meal with WD (215 ± 261 cm·min) (p < 0.001). Subjects had blood glucose levels measured after the meals with PGX (granules) and WD. Glucose response (AUC) was significantly lower (p < 0.001) after the PGX meal than for the WD meal. The high viscosity reported for PGX is a likely mechanism behind the significant satiety and blood glucose modulating effects observed in this study.

The development of lower-glycaemic index (GI) foods requires simple, palatable and healthy strategies. The objective of the present study was to determine the most effective dose of a novel viscous fibre supplement (PGX ® ) to be added to starchy foods to reduce their GI. Healthy subjects ( n 10) consumed glucose sugar (50 g in water × 3) and six starchy foods with a range of GI values (52–72) along with 0 (inert fibre), 2·5 or 5 g granular PGX ® dissolved in 250 ml water. GI testing according to ISO Standard 26 642-2010 was used to determine the reduction in GI. PGX ® significantly reduced the GI of all six foods ( P  < 0·001), with an average reduction of 19 % for the 2·5 g dose and 30 % for the 5 g dose, equivalent to a reducing the GI by 7 and 15 units, respectively. Consuming small quantities of the novel functional fibre PGX ® , mixed with water at the start of a meal, is an effective strategy to reduce the GI of common foods.