Randomised clinical trial: the clinical efficacy and safety of an alginate-antacid (Gaviscon Double Action) versus placebo, for decreasing upper gastrointestinal symptoms in symptomatic gastroesophageal reflux disease (GERD) in China.
Sun J,Yang C,Zhao H,Zheng P,Wilkinson J,Ng B,Yuan Y
Alimentary pharmacology & therapeutics
BACKGROUND:There is a paucity of large-scale studies evaluating the clinical benefit of the Gaviscon Double Action (DA) alginate-antacid formulation for treating gastroesophageal reflux disease (GERD) symptoms. AIM:Randomised double-blind placebo-controlled parallel-group study to evaluate efficacy and safety of Gaviscon DA in reducing heartburn, regurgitation and dyspepsia symptoms in individuals with mild-to-moderate GERD in China. METHODS:Participants with symptomatic GERD (n = 1107) were randomised to receive Gaviscon DA or placebo (two tablets four times daily) for seven consecutive days. The primary endpoint compared the change in Reflux Disease Questionnaire (RDQ) score for the GERD (heartburn + regurgitation) dimension between Gaviscon DA and placebo. Secondary endpoints compared the change in RDQ scores for individual heartburn, regurgitation and dyspepsia dimensions, overall treatment evaluation (OTE) scores and incidence of adverse events (AEs). RESULTS:Mean RDQ GERD scores: 2.51 for Gaviscon DA and 2.50 for placebo at baseline; 1.25 for Gaviscon DA and 1.46 for placebo post treatment. Gaviscon DA was statistically superior to placebo in reducing GERD and dyspepsia RDQ scores [least-squares mean (LSM) difference: GERD -0.21, P < 0.0001; dyspepsia -0.18, P = 0.0004], despite a substantial placebo response. The Gaviscon DA group reported more favourable overall treatment responses than the placebo group across all OTE categories (P < 0.0001). Superior relief of GERD symptoms was observed both in those with non-erosive and those with erosive reflux disease (LSM difference -0.14 [P = 0.038] and -0.29 [P < 0.0001] respectively). Incidence of AEs was similar in both groups. CONCLUSION:Gaviscon DA tablets provide effective and safe reduction in acid reflux and dyspepsia symptoms in Chinese individuals with mild-to-moderate GERD. ClinicalTrials.gov: NCT01869491.
A phase IIb, randomised, double-blind, placebo-controlled, dose-ranging investigation of the safety and efficacy of NTCELL [immunoprotected (alginate-encapsulated) porcine choroid plexus cells for xenotransplantation] in patients with Parkinson's disease.
Snow Barry,Mulroy Eoin,Bok Arnold,Simpson Mark,Smith Andrew,Taylor Kenneth,Lockhart Michelle,Lam Bb Janice,Frampton Christopher,Schweder Patrick,Chen Benson,Finucane Gregory,McMahon Adele,Macdonald Lorraine
Parkinsonism & related disorders
INTRODUCTION:Regenerative therapies in Parkinson's disease aim to slow neurodegeneration and re-establish damaged neuronal circuitry. Neurotrophins are potent endogenous regulators of neuronal survival, development and regeneration. They represent an attractive regenerative treatment option in Parkinson's disease. Porcine choroid plexus produces a number of neurotrophins, and can be safely delivered to the striatum in an encapsulated formulation (termed NTCELL) to protect them from immune attack. NTCELL has shown regenerative potential in animal models of stroke, Huntington's disease and Parkinson's disease. Following promising results from an initial open label safety study of intra-striatal delivery of NTCELL in human subjects, we sought to specifically investigate the safety and efficacy of NTCELL for the treatment of Parkinson's disease. METHODS:18 patients aged 56-65 years with idiopathic Parkinson's disease of at least 5 years duration were randomised to receive either sham surgery (general anaesthesia and partial thickness burr holes) or intra-striatal delivery of NTCELL (the 3 groups in the treatment arm receiving incremental NTCELL doses). RESULTS:At 26 weeks, we found no significant difference in total UPDRS scores ('on' and 'off'), UPDRS motor scores ('on' and 'off'), PDQ-39, UDysRS, timed walk or modified Hoehn and Yahr stage between patients implanted with NTCELL and patients undergoing sham procedure. There were no serious adverse events or xenogeneic viral transmission during the study. CONCLUSION:The study did not meet its primary efficacy end-point of a change in UPDRS at 26 weeks post-intervention compared with baseline. Stereotactic NTCELL implantation was safe and well tolerated.
Enhancing the functionality of chitosan- and alginate-based active edible coatings/films for the preservation of fruits and vegetables: A review.
Nair M Sneha,Tomar Maharishi,Punia Sneh,Kukula-Koch Wirginia,Kumar Manoj
International journal of biological macromolecules
A number of studies have established the potential of chitosan and alginate-based edible film/coatings for preserving the quality attributes of fruits and vegetables. Findings demonstrate that these films/coatings act as a barrier on the surface of fruits and vegetables which causes higher moisture and water retention, create favourable micro-environments by optimizing the concentration of gases and delays ripening. Sincere efforts are being further made to improve the efficiency of edible films using functional additives such as phenolics, essential oils (EOs) and nano-forms. These additives have unlocked a new dimension for enhancing functional properties of alginate/chitosan-based films. These functional compounds are now emerging as an important component of edible films/coatings for prolonging shelf-life of fruits and vegetables. The present review comprehensively elaborates recent studies on functional additives and their mechanism of action. Here we also establish their proficiency in extending quality and shelf-life of various fruits including guava, pear, blueberries and vegetables like cucumber, capsicum and mushroom. Principles behind antimicrobial and antioxidant activities of additives in preventing the food spoilage are also reviewed. Competency of phenolics, EOs and nano-forms in extending the shelf-life without affecting the nutritional properties and safety aspects of the fruits and vegetables still require further attention.
Comparative Study of Alginate and Omeprazole in Symptomatic Treatment of Non-erosive Gastroesophageal Reflux Disease.
Saifullah A M,Ahmed F,Shil B C,Banik R K,Saha S K,Chowdhury M,Haque A,Alam M S,Akhter A
Mymensingh medical journal : MMJ
Gastroesophageal reflux disease is widely reported most prevalent disease of the gastrointestinal tract. The burden of gastroesophageal reflux disease (GERD) is increasing in Asia and the majority of patients have non-erosive reflux disease. This prospective, open label, non random (consecutive), experimental study was performed due to compare the therapeutic efficacy of alginate and omeprazole in relieving symptoms of non erosive reflux disease (NERD) and was carried out in the Outpatient Department of Gastroenterology, Dhaka Medical College Hospital, Dhaka, Bangladesh from December 2013 to May 2014. Sixty patients were enrolled for this study and were divided into two groups. Among them, 30 subjects were assigned to the omeprazole group (Group I) and 30 subjects to the alginate group (Group II). Omeprazole 20mg enteric coated capsule daily and alginate 10ml three times daily were administered 14 days in this study. In ITT analysis, achieving complete symptom relief (heart burn) was 56.7% in alginate group & 60% in omeprazole group. Statistically which was not significant (p=0.793). In PP analysis, this was 65.4% and 66.7% respectively. In this study, the overall satisfaction of omeprazole & alginate was more than 86% and the mean duration of heart burn free was found 5.0±4.0 days in Group I and 3.65±2.8 days in Group II. The difference was not statistically (p>0.05) significant between two groups in this study. Therapeutic efficacy and safety profiles of alginate were comparable to omeprazole after two weeks treatment in NERD subjects. So alginate may be considered as a relevant and effective alternative medication in non-erosive reflux.
Analysis of toxicity and anticancer activity of micelles of sodium alginate-curcumin.
Karabasz Alicja,Lachowicz Dorota,Karewicz Anna,Mezyk-Kopec Renata,Stalińska Krystyna,Werner Ewa,Cierniak Agnieszka,Dyduch Grzegorz,Bereta Joanna,Bzowska Monika
International journal of nanomedicine
Background:Curcumin is a natural polyphenol with anti-inflammatory, chemopreventive and anticancer activity. However, its high hydrophobicity and poor bioavailability limit its medical application. The development of nanocarriers for curcumin delivery is an attractive approach to overcome its low bioavailability and fast metabolism in the liver. We synthesized a blood compatible alginate-curcumin conjugate, AA-Cur, which formed colloidally stable micelles of approximately 200 nm and, as previously shown, exerted strong cytotoxicity against mouse cancer cell lines. Here we analyze in vivo toxicity and antitumor activity of AA-Cur in two different mouse tumor models. Method:Potential toxicity of intravenously injected AA-Cur was evaluated by: i) analyses of blood parameters (morphology and biochemistry), ii) histology, iii) DNA integrity (comet assay), and iv) cytokine profiling (flow cytometry). Antitumor activity of AA-Cur was evaluated by measuring the growth of subcutaneously inoculated colon MC38-CEA- or orthotopically injected breast 4T1 tumor cells in control mice vs mice treated with AA-Cur. Results:Injections of four doses of AA-Cur did not reveal any toxicity of the conjugate, thus indicating the safety of its use. AA-Cur elicited moderate anti-tumor activity toward colon MC38-CEA or breast 4T1 carcinomas. Conclusion:The tested conjugate of alginate and curcumin, AA-Cur, is non-toxic and safe, but exhibits limited anticancer activity.
Double-blind, placebo-controlled study with alginate suspension for laryngopharyngeal reflux disease.
Tseng Wen-Hsuan,Tseng Ping-Huei,Wu Jia-Feng,Hsu Ya-Chin,Lee Ting-Yi,Ni Yen-Hsuan,Wang Hsiu-Po,Hsiao Tzu-Yu,Hsu Wei-Chung
OBJECTIVE:Treatment for laryngopharyngeal reflux disease (LPRD) is challenging because of delays in recognition and poor responsiveness to proton-pump inhibitor therapy. The aim of this study was to determine the efficacy and safety of liquid alginate suspension for treating LPRD. METHODS:A double-blind, placebo-controlled, prospective study comparing 8 weeks of treatment with Alginos Oral Suspension (TTY Biopharm Co. Ltd., Taipei, Taiwan) (sodium alginate 1,000 mg three times daily) with a placebo was conducted on patients who fulfilled the criteria of at least one symptom consistent with LPRD, a total reflux symptom index (RSI) score of > 10, and a total reflux finding score (RFS) of > 5. Those with erosive gastroesophageal reflux disease, as evidenced through screened transnasal upper gastrointestinal endoscopy, were excluded. Efficacy was assessed by RSI, RFS, and ambulatory multichannel intraluminal impedance and pH (MII-pH) monitoring. RESULTS:A total of 80 patients aged 22 to 72 years were enrolled. Compared with baseline, both Alginos (TTY Biopharm Co. Ltd.) and the placebo significantly reduced the total RSI (P < 0.001) and the total number of reflux episodes shown by MII-pH monitoring (P < 0.05) after 8 weeks of treatment. However, liquid alginate suspension was unable to show superiority over the placebo. The incidence of various adverse events from Alginos (TTY Biopharm Co. Ltd.) was relatively low (7.7%) and mild. CONCLUSION:This study showed that liquid alginate suspension was well tolerated by LPRD patients. It effectively improved symptoms and reflux numbers but was unable to show superiority over placebo. As observed in previous studies, a great placebo effect was present. The importance of lifestyle modification could not be overlooked. LEVEL OF EVIDENCE:2. Laryngoscope, 128:2252-2260, 2018.
Safety and efficacy of sodium and potassium alginate for pets, other non food-producing animals and fish.
,Rychen Guido,Aquilina Gabriele,Azimonti Giovanna,Bampidis Vasileios,Bastos Maria de Lourdes,Bories Georges,Chesson Andrew,Cocconcelli Pier Sandro,Flachowsky Gerhard,Kolar Boris,Kouba Maryline,López-Alonso Marta,López Puente Secundino,Mantovani Alberto,Mayo Baltasar,Ramos Fernando,Saarela Maria,Villa Roberto Edoardo,Wallace Robert John,Wester Pieter,Lundebye Anne-Katrine,Nebbia Carlo,Renshaw Derek,Innocenti Matteo Lorenzo,Gropp Jürgen
EFSA journal. European Food Safety Authority
Sodium and potassium alginate are intended to be used as technological additives (functional groups: emulsifiers, stabilisers, thickeners, gelling agents and binders). Sodium alginate is intended to be used in feedingstuffs for pets, other non food-producing animals and fish, with no maximum recommended use level. Potassium alginate is intended to be used in feedingstuffs for cats and dogs at levels up to 40,000 mg/kg feed (on dry matter). Since the functional properties of the additives are determined by the alginate content, sodium and potassium alginate were considered equivalent. The maximum dose considered safe for cats, dogs, other non food-producing animals, salmonids and other fish is 40,000 mg alginates (sodium and potassium salts)/kg complete feed. The use of alginates in feedingstuffs for fish is of no concern for the consumer. Alginates are reported not to be irritant to the skin but mildly irritant to the eyes. They are considered as potential sensitisers to the skin and the respiratory tract. Alginates are high-molecular-weight polymers naturally occurring in brown algae. Their use in feedingstuffs for fish does not pose a risk for the aquatic environment. Alginates are effective as stabilisers, thickeners, gelling agent and binders. No conclusion could be drawn on the efficacy of alginates as emulsifiers.
Efficacy and safety of alginate formulations in patients with gastroesophageal reflux disease: a systematic review and meta-analysis of randomized controlled trials.
Zhao C-X,Wang J-W,Gong M
European review for medical and pharmacological sciences
OBJECTIVE:Alginate formulations are increasingly being used for treating gastroesophageal reflux disease (GERD). However, the benefits of alginate versus control or proton pump inhibitors (PPIs) are somewhat unclear. We performed a systematic review and meta-analysis to summarize data from recent randomized controlled trials (RCTs) comparing the efficacy and safety of alginate-based formulation with PPIs or control for the treatment of GERD. MATERIALS AND METHODS:PubMed, Embase, Scopus, BioMed Central, CENTRAL, and Google scholar databases were searched from 1st January 2000 to 15th June 2020. Primary outcome was a reduction of symptoms while secondary outcomes were adverse events and treatment withdrawals. Ten articles with 11 RCTs were included. RESULTS:Qualitative analysis of four trials indicated better outcomes with alginates vs. placebo/antacids. Our pooled analysis, however, indicated no statistically significant difference between alginates and placebo/antacids for relief of heartburn, regurgitation, or dyspepsia. Similarly, no difference was seen between a combination of alginate and PPI vs. PPI alone for reduction of heartburn, regurgitation, or dyspepsia symptoms. The risk of adverse events and treatment withdrawal did not differ between the two groups in either comparison. Descriptive analysis of studies comparing alginate vs. PPI indicated no difference between the two drugs. CONCLUSIONS:Our study indicates that alginates may have greater efficacy than placebo/antacids in improving outcomes of GERD. However, current evidence on the efficacy of alginate-based formulations vs. PPI or the role of added alginates with PPI is questionable, and suggests no difference between the two drugs. The risk of adverse events with alginates is no greater than that of placebo or PPIs.
Efficacy and safety of 0.6% sodium alginate solution in endoscopic submucosal dissection for esophageal and gastric neoplastic lesion: A randomized controlled study.
Uemura Naomi,Oda Ichiro,Saito Yutaka,Ono Hiroyuki,Fujisaki Junko,Matsuhashi Nobuyuki,Ohata Ken,Yahagi Naohisa,Yada Tomoyuki,Satoh Masahiro,Tajiri Hisao,Inomata Masafumi,Kitano Seigo
Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society
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.
Randomized clinical trial: a double-blind, placebo-controlled study to assess the clinical efficacy and safety of alginate-antacid (Gaviscon Double Action) chewable tablets in patients with gastro-oesophageal reflux disease.
Wilkinson Joanne,Wade Alan,Thomas S Jane,Jenner Bartosz,Hodgkinson Victoria,Coyle Cathal
European journal of gastroenterology & hepatology
BACKGROUND:The alginate-antacid Gaviscon Double Action (Gaviscon DA) has a combined acid-neutralizing and reflux-suppressing action. Response to treatment in a symptomatic gastro-oesophageal reflux disease (GERD) population has not yet been tested in a large-scale clinical study. AIM:The aim of this study was to assess the efficacy and safety of Gaviscon DA compared with matched placebo tablets in the reduction of upper gastrointestinal symptoms in patients with GERD. PARTICIPANTS AND METHODS:In this multicentre, randomized, double-blind, placebo-controlled study, adults with GERD symptoms (N=424) received Gaviscon DA or placebo tablets for 7 days. The primary endpoint was a clinically important reduction of at least 1.5 points in the Reflux Disease Questionnaire (RDQ) GERD dimension (combined heartburn/regurgitation) between baseline and the end of the treatment. Secondary endpoints included the change in RDQ score from baseline for individual RDQ dimensions and Overall Treatment Evaluation. RESULTS:A significantly greater proportion of patients treated with Gaviscon DA met the primary endpoint compared with placebo (47.8 vs. 33.2%, respectively, P=0.0031; odds ratio: 1.85, 95% confidence interval: 1.23-2.78). A significant treatment effect was also observed for heartburn, regurgitation and dyspepsia individually. Patients in the Gaviscon DA group rated their overall treatment response greater than patients in the placebo group [mean Overall Treatment Evaluation (SD): 3.2 (3.08) vs. 2.2 (3.34); P<0.001]. No notable differences in the incidence of adverse events were observed between treatments. CONCLUSION:The alginate-antacid combination, Gaviscon DA, is an effective and well-tolerated treatment to reduce reflux symptoms and associated dyspepsia in symptomatic GERD patients.
The effectiveness and safety of recombinant human growth hormone combined with alginate dressing in the treatment of diabetic foot ulcer: A protocol for systematic review and meta-analysis.
Zhou Deng-Rong,Deng Hai-Yan,Pu Lin-Li,Lin Shao-Lan,Gou Rong,Wang Feng-Ling
BACKGROUND:Diabetic foot ulcer (DFU) is one of the serious complications of diabetes. It is the result of a joint effect of lower extremities vascular lesions, neuropathy, and infection, which require amputation and even threaten the life of the patient. At present, the conventional treatment for DFU includes infection control, wound care, wound reduction, reduction of foot pressure, use of dressings that are beneficial to wound surface healing, etc, but the effectiveness is not satisfactory. Recombinant human growth hormone and alginate dressing have been used in clinical, but there is lack of the relevant evidence of its effectiveness and safety, so this study evaluates the clinical effectiveness and safety of recombinant human growth hormone combined with alginate dressing in the treatment of DFU by systematic evaluation, the purpose is to provide a theoretical basis for the treatment of diabetic foot ulcer. METHODS:This study mainly retrieves the randomized controlled trial of recombinant human growth hormone combined alginate dressing in the treatment of DFU in 7 electronic databases, such as PubMed, EMbase, Cochrane Library, SinoMed, CNKI, WANGFANG database, and VIP database. All the retrieval dates of database are from the establishment of the database until May 31, 2020. At the same time, searching the related degree papers, conference papers, and other gray literature by manual. The original literature data are independently screened and extracted by 2 researchers on the basis of inclusion and exclusion criteria and literature information sheets, and cross-checked and resolved through group discussions and consultations when there are differences of the opinion. Assessing the methodological quality of inclusion in the study based on the "Bias Risk Assessment Form" of the Cochrane Collaboration Network. Using the software of RevMan 5.3.3 and STATA 13.0 for statistical analysis. RESULTS:This study compares the main and secondary outcome indicators by systematic evaluation and it will provide strong evidence of recombinant human growth hormone combined alginate dressing in the treatment of DFU. ETHICS AND DISSEMINATION:All data in this study are obtained through the web database and do not involve humans, so ethical approval is not suitable for this study. OSF REGISTRATION NUMBER:DOI 10.17605/OSF.IO/W6P24. CONCLUSION:This study will give positive conclusions about the effectiveness and safety of recombinant human growth hormone combined alginate dressing in the treatment of DFU.
The Safety and Tolerability of a Potential Alginate-Based Iron Chelator; Results of A Healthy Participant Study.
Horniblow Richard D,Mistry Pritesh,Quraishi Mohammed N,Beggs Andrew D,Van de Wiele Tom,Iqbal Tariq H,Tselepis Chris
Evidence supporting the ferro-toxic nature of iron in the progression of inflammatory bowel disease (IBD) is becoming well established. A microbial dysbiosis is observed in IBD patients, and intra-luminal colonic-iron is able to support a more pathogenic community of bacteria; whether this is attributed to the development of IBD and how iron could be mediating these microbial changes is still unknown. Dietary fibres are commonly used in pre-biotic supplements to beneficially affect the host by improving the viability of bacterial communities within the colon. Alginates are a class of biopolymers considered as prebiotics due to their fibre-like composition and are able to bind metal cations, in particular, iron. Considering that iron excess is able to negatively alter the microbiome, the use of alginate as a food supplement could be useful in colonic-iron chelation. As such, this first-in-man study aimed to assess whether the use of alginate as a dietary iron chelator was both safe and well tolerated. In addition, the impact of alginate on the microbiome and iron levels was assessed by using an intestinal model SHIME (Simulation of the Human Intestinal Microbial Ecosystem). Alginate was supplemented into the diets (3 g/day) of healthy volunteers ( = 17) for 28 days. Results from this study suggest that daily ingestion of 3 g alginate was well tolerated with very minor side effects. There were no detrimental changes in a variety of haematological parameters or the intestinal microbiome. The bacterial communities within the SHIME model were also not influenced by iron and or alginate; it is possible that alginate may be susceptible to bacterial or enzymatic degradation within the gastro-intestinal tract.
Re-evaluation of propane-1,2-diol alginate (E 405) as a food additive.
,Younes Maged,Aggett Peter,Aguilar Fernando,Crebelli Riccardo,Filipič Metka,Frutos Maria Jose,Galtier Pierre,Gott David,Gundert-Remy Ursula,Kuhnle Gunter Georg,Lambré Claude,Leblanc Jean-Charles,Lillegaard Inger Therese,Moldeus Peter,Mortensen Alicja,Oskarsson Agneta,Stankovic Ivan,Waalkens-Berendsen Ine,Woutersen Rudolf Antonius,Wright Matthew,Brimer Leon,Mosesso Pasquale,Christodoulidou Anna,Horváth Zsuzsanna,Lodi Federica,Tard Alexandra,Dusemund Birgit
EFSA journal. European Food Safety Authority
The present opinion deals with the re-evaluation of propane-1,2-diol alginate (E 405) when used as a food additive. The Panel noted that absorption, distribution, metabolism and excretion (ADME) data on propane-1,2-diol alginate gave evidence for the hydrolysis of this additive into propane-1,2-diol and alginic acid. These two compounds have been recently re-evaluated for their safety of use as food additives (EFSA ANS Panel, 2017, 2018). Consequently, the Panel considered in this opinion the major toxicokinetic and toxicological data of these two hydrolytic derivatives. No adverse effects were reported in subacute and subchronic dietary studies with propane-1,2-diol alginate. The available data did not indicate a genotoxic concern for propane-1,2-diol alginate (E 405) when used as a food additive. Propane-1,2-diol alginate, alginic acid and propane-1,2-diol were not of concern with respect to carcinogenicity. The Panel considered that any adverse effect of propane-1,2-diol alginate would be due to propane-1,2-diol. Therefore, the acceptable daily intake (ADI) of the food additive E 405 is determined by the amount of free propane-1,2-diol and the propane-1,2-diol released from the food additive after hydrolysis. According to the EU specification, the concentration of free and bound propane-1,2-diol amounts to a maximum of 45% on a weight basis. On the worst-case assumption that 100% of propane-1,2-diol would be systemically available and considering the ADI for propane-1,2-diol of 25 mg/kg body weight (bw) per day, the Panel allocated an ADI of 55 mg/kg bw per day for propane-1,2-diol alginate. The Panel concluded that exposure estimates did not exceed the ADI in any of the population groups from the use of propane-1,2-diol alginate (E 405) as a food additive. Therefore, the Panel concluded that there is no safety concern at the authorised use levels.
Effect of alginate on satiation, appetite, gastric function, and selected gut satiety hormones in overweight and obesity.
Odunsi Suwebatu T,Vázquez-Roque María I,Camilleri Michael,Papathanasopoulos Athanasios,Clark Matthew M,Wodrich Lynne,Lempke Mary,McKinzie Sanna,Ryks Michael,Burton Duane,Zinsmeister Alan R
Obesity (Silver Spring, Md.)
Lack of control of food intake, excess size, and frequency of meals are critical to the development of obesity. The stomach signals satiation postprandially and may play an important role in control of calorie intake. Sodium alginate (based on brown seaweed Laminaria digitata) is currently marketed as a weight loss supplement, but its effects on gastric motor functions and satiation are unknown. We evaluated effects of 10 days treatment with alginate or placebo on gastric functions, satiation, appetite, and gut hormones associated with satiety in overweight or obese adults. We conducted a randomized, 1:1, placebo-controlled, allocation-concealed study in 48 overweight or obese participants with excluded psychiatric comorbidity and binge eating disorder. All underwent measurements of gastric emptying (GE), fasting, and postprandial gastric volumes (GVs), postprandial satiation, calorie intake at a free choice meal and selected gut hormones after 1 week of alginate (three capsules vs. matching placebo per day, ingested 30 min before the main meal). Six capsules were ingested with water 30 min before the GE, GV, and satiation tests on days 8-10. There were no treatment group effects on GE or volumes, gut hormones (ghrelin, cholecystokinin (CCK), glucagon-like peptide-1 (GLP-1), peptide YY (PYY)), satiation, total and macronutrient calorie intake at a free choice meal. There was no difference detected in results between obese and overweight patients. Alginate treatment for a period of 10 days showed no effect on gastric motor functions, satiation, appetite, or gut hormones. These results question the use of short-term alginate treatment for weight loss.
Acute effects of different dietary polysaccharides added in milk on food intake, postprandial appetite and glycemic responses in healthy young females.
Arshad Muhammad Umair,Ishtiaq Saima,Anjum Faqir Muhammad,Saeed Farhan,Chatha Shahzad Ali Shahid,Imran Ali
International journal of food sciences and nutrition
In the present study we compared the postprandial glycemic and satiety responses of different dietary polysaccharides when added in milk (2% M.F.). The objective of this study was to evaluate different polysaccharides against postprandial glucose, appetite responses and food intake at subsequent meal. In a repeated measures design, 30 females (18-30 years) consumed 250 ml milk 2% M.F. (control), or milk with carrageenan (2.5 g), guar gum (2.5 g) and alginate (2.5 g), followed by an ad libitum pizza meal after 120 min. Alginate and guar gum addition resulted in lower caloric intake at subsequent pizza meal. The post-treatment (0-120 min) glucose and average appetite were suppressed by alginate and guar gum (p < 0.0001), with more pronounced effect of guar gum. However, alginate resulted in lower blood glucose (p < 0.0001) compared with control and carrageenan during post-treatment. Alginate and guar gum added beverages would be beneficial in short-term regulation of postprandial glycemia and satiety.
Daily ingestion of alginate reduces energy intake in free-living subjects.
Paxman J R,Richardson J C,Dettmar P W,Corfe B M
Sodium alginate is a seaweed-derived fibre that has previously been shown to moderate appetite in models of acute feeding. The mechanisms underlying this effect may include slowed gastric clearance and attenuated uptake from the small intestine. In order to assess whether alginate could be effective as a means of appetite control in free-living adults, 68 males and females (BMI range: 18.50-32.81 kg/m(2)) completed this randomised, controlled two-way crossover intervention to compare the effects of 7 day daily ingestion of a strong-gelling sodium alginate formulation against a control. A sodium alginate with a high-guluronate content was chosen because, upon ingestion, it forms a strong gel in the presence of calcium ions. Daily preprandial ingestion of the sodium alginate formulation produced a significant 134.8 kcal (7%) reduction in mean daily energy intake. This reduced energy intake was underwritten by significant reductions in mean daily carbohydrate, sugar, fat, saturated fat and protein intakes. The absence of any significant interaction effects between the main effect of preload type and those of gender, BMI classification and/or timing of preload delivery indicates the efficacy of this treatment for individuals in different settings. These findings suggest a possible role for a strong-gelling sodium alginate formulation in the future management of overweight and obesity.
Review: efficacy of alginate supplementation in relation to appetite regulation and metabolic risk factors: evidence from animal and human studies.
Georg Jensen M,Pedersen C,Kristensen M,Frost G,Astrup A
Obesity reviews : an official journal of the International Association for the Study of Obesity
This review provides a critical update on human and animal studies investigating the effect of alginate supplementation on appetite regulation, glycaemic and insulinemic responses, and lipid metabolism with discussion of the evidence on potential mechanisms, efficacy and tolerability. Dependent on vehicle applied for alginate supplementation, the majority of animal and human studies suggest that alginate consumption does suppress satiety and to some extent energy intake. Only one long-term intervention trial found effects on weight loss. In addition, alginates seem to exhibit beneficial influence on postprandial glucose absorption and insulin response in animals and humans. However, alginate supplementation was only found to have cholesterol-lowering properties in animals. Several mechanisms have been suggested for the positive effect observed, which involve delayed gastric emptying, increased viscosity of digesta and slowed nutrient absorption in the small intestine upon alginate gel formation. Despite reasonable efficacy and tolerability from the acute or short-term studies, we still realize there is a critical need for development of optimal alginate types and vehicles as well as studies on further long-term investigation on alginate supplementation in humans before inferring that it could be useful in the management of obesity and the metabolic syndrome.
The role of alginates in regulation of food intake and glycemia: a gastroenterological perspective.
El Khoury D,Goff H D,Anderson G H
Critical reviews in food science and nutrition
Regulation of food intake through modulation of gastrointestinal responses to ingested foods is an ever-growing component of the therapeutic approaches targeting the obesity epidemic. Alginates, viscous and gel-forming soluble fibers isolated from the cell wall of brown seaweeds and some bacteria, are recently receiving considerable attention because of their potential role in satiation, satiety, and food intake regulation in the short term. Enhancement of gastric distension, delay of gastric emptying, and attenuation of postprandial glucose responses may constitute the basis of their physiological benefits. Offering physical, chemical, sensorial, and physiological advantages over other viscous and gel-forming fibers, alginates constitute promising functional food ingredients for the food industry. Therefore, the current review explores the role of alginates in food intake and glycemic regulation, their underlying modes of action and their potential in food applications.
Acute effect of alginate-based preload on satiety feelings, energy intake, and gastric emptying rate in healthy subjects.
Georg Jensen Morten,Kristensen Mette,Belza Anita,Knudsen Jes C,Astrup Arne
Obesity (Silver Spring, Md.)
Viscous dietary fibers such as sodium alginate extracted from brown seaweed have received much attention lately for their potential role in energy regulation through the inhibition of energy intake and increase of satiety feelings. The aim of our study was to investigate the effect on postprandial satiety feelings, energy intake, and gastric emptying rate (GER), by the paracetamol method, of two different volumes of an alginate-based preload in normal-weight subjects. In a four-way placebo-controlled, double-blind, crossover trial, 20 subjects (age: 25.9 ± 3.4 years; BMI: 23.5 ± 1.7 kg/m(2)) were randomly assigned to receive a 3% preload concentration of either low volume (LV; 9.9 g alginate in 330 ml) or high volume (HV; 15.0 g alginate in 500 ml) alginate-based beverage, or an iso-volume placebo beverage. The preloads were ingested 30 min before a fixed breakfast and again before an ad libitum lunch. Consumption of LV-alginate preload induced a significantly lower (8.0%) energy intake than the placebo beverage (P = 0.040) at the following lunch meal, without differences in satiety feelings or paracetamol concentrations. The HV alginate significantly increased satiety feelings (P = 0.038), reduced hunger (P = 0.042) and the feeling of prospective food consumption (P = 0.027), and reduced area under the curve (iAUC) paracetamol concentrations compared to the placebo (P = 0.05). However, only a 5.5% reduction in energy intake was observed for HV alginate (P = 0.20). Although they are somewhat contradictory, our results suggest that alginate consumption does affect satiety feelings and energy intake. However, further investigation on the volume of alginate administered is needed before inferring that this fiber has a possible role in short-term energy regulation.
Effect of sodium alginate addition to chocolate milk on glycemia, insulin, appetite and food intake in healthy adult men.
El Khoury D,Goff H D,Berengut S,Kubant R,Anderson G H
European journal of clinical nutrition
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.