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This multi-center prospective randomized controlled trial was a tolerance and safety study investigating the thickener locust bean gum (LBG) in infants with regurgitation, to support the re-evaluation of the safety of LBG in infant formula. The primary objective was to demonstrate that after an 8-week intervention, stool consistency was not inferior (i.e., was not looser or more watery) in infants fed an anti-regurgitation (AR) formula containing LBG vs. the stool consistency of infants fed with an unthickened control formula. A total of 103 full-term infants with regurgitation were randomized to the test or control formula. The test formula contained LBG (0.4 g/100 mL), short-chain galacto-oligosaccharides, and long-chain fructo-oligosaccharides (scGOS/lcFOS; 9:1; 0.4 g/100 mL) and postbiotics and the control formula contained scGOS/lcFOS (0.8 g/100 mL), the same amount of postbiotics, and did not contain LBG. The average stool consistency score at the 8th intervention week was the primary outcome parameter. Secondary outcome parameters were stool consistency at other timepoints, stool frequency, Infant Gastrointestinal Symptom Questionnaire (IGSQ) score, growth, (serious) adverse events ([S]AEs), regurgitation severity, and infant well-being. Overall, the infants were 36.9 ± 12.9 [mean ± SD] days old, 62.7% girls in the test, and 50.0% girls in the control group. The primary analysis showed that the test group did not have looser or more watery stools than the control group. IGSQ sum scores decreased comparably in both groups. The frequency of regurgitation was significantly lower in the test group compared to the control group (mixed model repeated measurement, p ≤ 0.028) and parent-reported well-being scores were favorable. Adequate growth was observed in both groups. Both products were well-tolerated and safe and the AR formula with LBG was efficacious in reducing regurgitation frequency. This study provides further evidence for the dietary management of regurgitation by LBG-containing formulae in infants who are not exclusively breastfed, and the reassurance it can bring to parents.

Background and Aims: Partially hydrolyzed guar gum (PHGG) is a water-soluble fiber supporting digestive health with well-established safety and efficacy. This open-label, single-arm, multicenter trial aimed to assess the tolerability and safety of a semi-elemental enteral formula containing PHGG at 12 g/L in tube-fed young children., Methods: Children aged 1-4 years with stable conditions requiring tube feeding to provide ≥80% of their nutritional needs received the study formula for seven days. Tolerability, safety, adequacy of energy/protein intake, and weight change were assessed., Results: Of 24 children (mean age 33.5 months; 10 [41.7%] female), 23 (95.8%) commenced treatment and 18 (75%) completed the study. All children had underlying neuro-developmental disabilities, often in association with gastrointestinal comorbidities requiring treatment for constipation (70.8%) or gastroesophageal reflux (66.7%). The formula was well-tolerated by 19 (82.6%) subjects, while 4 (17.4%; 95% CI: 5%, 39%) subjects withdrew early from the study due to gastrointestinal intolerance. The mean (SD) percentage energy and protein intake across the 7-day period were 103.5% (24.7) and 139.5% [50], respectively. Weight remained stable over the 7-day period (p = 0.43). The study formula was associated with a shift towards softer and more frequent stools. Pre-existing constipation was generally well controlled, and 3/16 (18.7%) subjects ceased laxatives during the study. Adverse events were reported in 12 (52%) subjects and were deemed 'probably related' or 'related' to the formula in 3 (13%) subjects. Gastrointestinal adverse events appeared more common in fiber-naïve patients (p = 0.09)., Conclusion: The present study indicates that the study formula was safe and generally well tolerated in young tube-fed children., Gov Identifier: NCT04516213., Competing Interests: Declaration of competing interest All participating institutions received funding from Nestlé Health Science to complete the study. GM has given lectures for Nestlé Health Science and participated in another study funded by Nestlé Health Science. RGH and BZ are employees of Nestlé Health Science. TS declared no conflict of interest., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Herbal products with an antioxidant capacity can boost male reproductive functions. The empiric use of Ceratonia siliqua (carob) for its antioxidant properties is common among infertile men in Iran and Turkey. The objective of this study is to investigate the effects of C. siliqua (carob) on semen parameters, oxidative stress markers, and pregnancy rate in a parallel randomized, controlled study. A total of 60 infertile men with oligozoospermia, asthenospermia, and teratospermia were recruited from April 2018 to March 2019. Participants were divided randomly into the following two groups: carob syrup twice a day or vitamin E 100 mg twice a day for 3 months. Semen analysis was performed and hormonal levels and stress oxidative markers were measured in each treatment arm after 3 months. The quality of semen parameters improved in the carob group compared with Vit E semen count (p = 0.04 Cohen's d = .51), morphology (p = 0.001 Cohen's d = .93) and motility parameters (p = 0.002 Cohen's d = .90) were significantly higher in the carob group. No significant difference can be detected in post-treatment hormonal parameters and oxidative markers between groups, except for total antioxidant capacity(TAC) which was higher after post-treatment in carob group. A significantly higher pregnancy rate was found among the carob group. The administration of carob may be an effective agent for the improvement of semen parameters, probably related both to its involvement in the changing of testosterone level and to its antioxidant properties. Nevertheless, additional studies to evaluate the optimal dose and duration of treatment are needed. The trial has been registered in the Iranian Registry of Clinical Trials (Registration number: IRCT20171209037794N1.

Partially hydrolyzed guar gum (PHGG) is a water-soluble dietary fiber and is used in solid and liquid food to regulate gut function. The aim of this study was to investigate effects of PHGG on bowel movements (stool form and frequency), plasma bile acids, quality of life, and gut microbiota of healthy volunteers with a tendency toward diarrhea, i.e., irritable bowel syndrome diarrhea (IBS-D)-like symptoms. A randomized, double-blind, placebo-controlled, and parallel trial was performed on 44 healthy volunteers (22 males, 22 females, 41.9 ± 6.3 years old (average ± SD)) with minimum 7 bowel movements every week, wherein above 50% of their stool was between the Bristol stool scale (BSS) value of 5 and 6. Intake of the PHGG for 3 months significantly improved stool form, evaluated using BSS, and had no effects on stool frequency. BSS was significantly normalized in the group consuming the PHGG compared with the placebo. Comprehensive fecal microbiome analysis by the 16S rRNA-sequence method detected significant changes in the ratio of some bacteria, such as an increase of Bifidobacterium ( p < 0.05) in the PHGG group. Our results suggest that intake of PHGG improves human stool form via regulating intestinal microbiota.

Background: Galactomannan(s) are plant-derived fiber shown to reduce post-prandial blood glucose by delaying intestinal absorption of carbohydrates and slowing down gastric emptying. We examined glucose-lowering effects of BTI320, a propriety fractionated mannan(s) administered as a chewable tablet before meal in a proof-of-concept study in Chinese subjects with prediabetes., Methods: Sixty Chinese adults aged 18-70 years with either impaired fasting glucose, impaired glucose tolerance, or glycated haemoglobin 5.7-6.4% (39-46 mmol/mol), were randomly assigned in 2:2:1 ratio to either BTI320 8 g (high dose), BTI320 4 g (low dose) or matching-placebo three times daily before meal for 16 weeks. The primary endpoint was change in fructosamine in subjects treated with BTI320 compared with placebo from baseline to week 4. Indices of glycaemic variability based on continuous glucose monitoring (CGM) and standard meal tolerance test were explored in secondary analyses., Results: Of 60 subjects randomized, 3 subjects discontinued study treatment prematurely. In intention-to-treat analysis, no significant differences in change in serum fructosamine between low or high dose BTI320 and placebo were observed. Using random effect models, adjusted for variability by meals, treatment with low dose BTI320 was associated with reduction in 1-h (p < 0.01), 2-h (p = 0.01) and 3-h (p = 0.02) post-prandial incremental glucose area-under-curve and post-meal maximum glucose (p = 0.03) compared with placebo. Subjects receiving low dose BTI320 had greater body weight reduction than placebo group., Conclusions: BTI320 did not change fructosamine levels compared with placebo. BTI320 reduced glycaemic variability based on CGM indices., Trial Registration: The study was registered at www.clinicaltrials.gov , reference number NCT02358668 (9 February 2015).

Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease worldwide, yet the pathogenesis of NAFLD is only partially understood. Here, we investigated the role of the gut bacteria in NAFLD by stimulating the gut bacteria via feeding mice the fermentable dietary fiber, guar gum (GG), and suppressing the gut bacteria via chronic oral administration of antibiotics. GG feeding profoundly altered the gut microbiota composition, in parallel with reduced diet-induced obesity and improved glucose tolerance. Strikingly, despite reducing adipose tissue mass and inflammation, GG enhanced hepatic inflammation and fibrosis, concurrent with markedly elevated plasma and hepatic bile acid levels. Consistent with a role of elevated bile acids in the liver phenotype, treatment of mice with taurocholic acid stimulated hepatic inflammation and fibrosis. In contrast to GG, chronic oral administration of antibiotics effectively suppressed the gut bacteria, decreased portal secondary bile acid levels, and attenuated hepatic inflammation and fibrosis. Neither GG nor antibiotics influenced plasma lipopolysaccharide levels. In conclusion, our data indicate a causal link between changes in gut microbiota and hepatic inflammation and fibrosis in a mouse model of NAFLD, possibly via alterations in bile acids., (Copyright © 2017 by the American Society for Biochemistry and Molecular Biology, Inc.)

We present a case that highlights the difficulties with diagnosis and the dangers of occupational allergic sinusitis and asthma left unrecognized. We describe the case history of a man who experienced work-related symptoms 1 year after beginning work as a cheesemaker at a creamery, and whose respiratory symptoms progressively worsened over 16 years before an occupational cause of his asthma was identified. His initial discrete episodes of sinusitis and acute bronchitis evolved into persistent asthma of increasing severity with exacerbations requiring repeated emergency room treatment. The case described in our report emphasizes the importance of clinician diagnosis of OA, and subsequent removal from exposure, such that asthma severity does not progress to near-fatal or fatal asthma in the sensitized worker. As demonstrated by this case report, identification of an occupational cause of asthma relies on a high degree of suspicion and excellent detective work by the clinician., (© Published 2017. This article is a U.S. Government work and is in the public domain in the USA.)

Studies have reported a positive effect of prebiotics on the bioavailability of iron. This study evaluated the effect of partially hydrolyzed guar gum (PHGG) on iron absorption mechanisms in anemic rats. Male Wistar rats were fed 75g American Institute of Nutrition Rodent Diets for growth, pregnancy and lactation (AIN93-G) without iron for three weeks in order to induce iron deficiency anemia. Then they were fed a control diet (n = 12; without fiber) or a diet with 7.5% of PHGG (n = 12), both without iron. Food intake, body growth and the feed efficiency coefficient (FEC) were measured. The animals were euthanized after two weeks of treatment. The weight of the organs, the pH of the cecal content, and the hepatic iron and ferroportin expression in the cecum, duodenum, and liver were assessed. The intake of PHGG reduced food intake without affecting body growth, and there was a difference between the groups regarding the FEC (p = 0.026), with the highest value found in the PHGG group. The weight of the cecal content increased (p ≤ 0.001) and the pH of the cecal content was significantly lower in the PHGG group. The intake of PHGG significantly increased ferroportin expression in the cecum; however, the difference was not significant in the duodenum and the liver. PHGG seems to have a positive influence on iron absorption through transporter expression, and structural and physiological changes in the colon of anemic growing animals.

Tuberculosis remains a major global health problem and alternative therapeutic approaches are needed. Considering the high prevalence of lung tuberculosis (80% of cases), the pulmonary delivery of antitubercular drugs in a carrier system capable of reaching the alveoli, being recognised and phagocytosed by alveolar macrophages (mycobacterium hosts), would be a significant improvement to current oral drug regimens. Locust bean gum (LBG) is a polysaccharide composed of galactose and mannose residues, which may favour specific recognition by macrophages and potentiate phagocytosis. LBG microparticles produced by spray-drying are reported herein for the first time, incorporating either isoniazid or rifabutin, first-line antitubercular drugs (association efficiencies >82%). Microparticles have adequate theoretical properties for deep lung delivery (aerodynamic diameters between 1.15 and 1.67 μm). The cytotoxic evaluation in lung epithelial cells (A549 cells) and macrophages (THP-1 cells) revealed a toxic effect from rifabutin-loaded microparticles at the highest concentrations, but we may consider that these were very high comparing with in vivo conditions. LBG microparticles further evidenced strong ability to be captured by macrophages (percentage of phagocytosis >94%). Overall, the obtained data indicated the potential of the proposed system for tuberculosis therapy.

The paper present experimental materials of intragastric administration of silver nanoparticles encapsulated in polymer matrix of arabinogalactan by white outbred male rats. Animals were injected "pure" arabinogalactan and colloid silver solution containing silver macroform separately for comparison. Research provided data about status of brain tissue at the impact of these substances on organism. Histological analysis revealed the presence of a pathological process, character and intensity of which varied depending on the type of injected material. Pathological process under the influence of silver-arabinogalactan characterized by appearance in brain tissue of perivascular edema and development of acute inflammation in formation of glial scars, swelling of vascular bundles in sum.

Background: The impact of thickening agents and viscosity levels on sensory perception was studied in model fruit drinks. Four formulations were prepared that varied in the sweetener blend (erythritol, maltitol and/or steviol glycosides). Locust bean gum and its blends with either xanthan or carrageenan were used to adjust viscosity levels (20, 40, and 70 mPa s). The ranges of viscosity and sweetness level were selected to represent a typical concentration range in commercially available beverages., Results: An increase in viscosity resulted in significant increases in pulpiness, sliminess and perceived viscosity (P-values ≤ 0.001), which were not dependent on sweeteners or hydrocolloid type. Taste perception remained largely unchanged irrespective of the hydrocolloid used., Conclusion: The impact of viscosity on sweetness and taste perception was much smaller in the concentrations used than has been generally reported. The effect of the type of hydrocolloid on the perception of taste attributes was greater than that of viscosity., (© 2014 Society of Chemical Industry.)

Strategically developed natural polymer-based controlled release multiparticulate drug delivery systems have gained special interest for “spatial placement” and “temporal delivery” of drug molecules. In our earlier study, locust bean gum-poly(vinyl alcohol) interpenetrating polymer network (LBG-PVA IPN), carboxymethylated locust bean gum-poly(vinyl alcohol) interpenetrating polymer network (CMLBG-PVA IPN) and acrylamide grafted locust bean gum-poly(vinyl alcohol) interpenetrating polymer network (Am-g-LBG-PVA IPN) were prepared and characterized. The present study deals with accelerating stability testing, comparative bio-safety and single dose in vivo pharmacokinetic study of all three IPN microspheres for controlled oral delivery of buflomedil hydrochloride (BH). From the stability study, it was observed that the particles were stable throughout the study period. From toxicity and biodegradability study it was proved that the microspheres were safe for internal use and complied with bio-safety criterion. From the in vivo pharmacokinetic study in rabbits, it was observed that the CMLBG-PVA IPN microspheres possessed almost similar Tmax value with BH oral suspension. However, in comparison between the LBG-PVA and Am-g-LBG-PVA IPN microspheres, the later showed well controlled release property than the first in biological condition. Thus, this type of delivery system might be useful to achieve the lofty goals of the controlled release drug delivery.

Locust bean gum (LBG) is a galactomannan polysaccharide used as thickener in infant formulas with the therapeutic aim to treat uncomplicated gastroesophageal reflux (GER). Since its use in young infants below 12weeks of age is not explicitly covered by the current scientific concept of the derivation of health based guidance values, the present integrated safety review aimed to compile all the relevant preclinical toxicological studies and to combine them with substantial evidence gathered from the clinical paediatric use as part of the weight of evidence supporting the safety in young infants below 12weeks of age. LBG was demonstrated to have very low toxicity in preclinical studies mainly resulting from its indigestible nature leading to negligible systemic bioavailability and only possibly influencing tolerance. A standard therapeutic level of 0.5g/100mL in thickened infant formula is shown to confer a sufficiently protective Margin of Safety. LBG was not associated with any adverse toxic or nutritional effects in healthy term infants, while there are limited case-reports of possible adverse effects in preterms receiving the thickener inappropriately. Altogether, it can be concluded that LBG is safe for its intended therapeutic use in term-born infants to treat uncomplicated regurgitation from birth onwards., (Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.)

Background and Aim: Partially hydrolyzed guar gum (PHGG) is a water-soluble, non-gelling dietary fiber with a wide range of uses in clinical nutrition. The aim of this prospective study was to investigate the effect of guar gum on colonic transit time (CTT) and symptoms of chronic constipation., Methods: We enrolled patients fulfilling Rome III criteria for chronic constipation. CTT was measured before and at the end of treatment. After a 2-week run-in period, patients received 5 mg PHGG daily for 4 weeks. During study period, patients kept daily symptoms, stool and laxative usage diaries. They also recorded their symptom-related satisfaction weekly and treatment adverse events., Results: Forty-nine patients received treatment; 39 (80 %) completed the study. Treatment significantly reduced colon transit time, from 57.28 ± 39.25 to 45.63 ± 37.27 h (p = 0.026), a reduction more prominent in slow transit patients (from 85.50 ± 27.75 to 63.65 ± 38.11 h, p = 0.016). Overall, the weekly number of complete spontaneous and spontaneous bowel movements increased significantly (p < 0.001); the latter correlated significantly with the acceleration of CTT in the overall population and in slow transit patients (B = 0.382; p = 0.016 and B = 0.483; p = 0.023, respectively). In addition, the number of bowel movements with straining decreased (p < 0.001) and stool form improved (p < 0.001), while days with laxative intake and days with abdominal pain decreased (p = 0.001 and p = 0.027, respectively)., Conclusion: Four-week PHGG use accelerates colon transit time in patients with chronic constipation, especially in those with slow transit, and improves many of their symptoms including frequency of bowel movements.

Objective: Larch arabinogalactan (ResistAid * ) may prevent cold infections due to its immune-stimulatory properties. In a placebo-controlled, double-blind, randomized clinical trial, the effect of a proprietary larch arabinogalactan preparation on the incidences of common colds and its effect on cold symptoms, as a well established model for immune function, was compared to placebo., Research Design and Methods: A total of 199 healthy participants who had a self reported cold infection rate of three in 6 months were randomly assigned to receive a total of either 4.5 g of an arabinogalactan preparation (n = 101) or placebo (n = 98) over a period of 12 weeks., Main Outcome Measures: The participants documented each common cold episode in a diary, and rated 10 predefined infection symptoms on a 4 point rating scale during an infection period, resulting in an infection score. The common cold episodes were confirmed by medical doctors., Clinical Trial Registration: ISRCTN41183655., Results: In the full analysis set (FAS), arabinogalactan tended to decrease the incidence of common cold (p = 0.055). The number of participants affected by a cold was significantly reduced by arabinogalactan supplementation (p = 0.038). Concerning the per protocol (PP) collective, the incidences of common cold (p = 0.040) and the number of participants affected by the infection (p = 0.033) were significantly fewer after arabinogalactan compared to placebo consumption. The severity of symptoms at episode start as experienced by the participants was significantly higher after arabinogalactan supplementation (p = 0.028). The treatment was well tolerated with no significant differences between the study groups., Conclusion: The present study demonstrated that larch arabinogalactan increased the body's potential to defend against common cold infection. While the immunomodulatory effect of arabinogalactan can be assumed, its mechanism of action remains to be elucidated.

Arabinogalactan (AG), a water soluble polysaccharide with more than 80 mol% galactose units, was hydrophobized by covalent attachment of palmitoyl chains using a base-catalyzed esterification reaction with the objective of effective amalgamation of arabinogalactan in liposomes for targeting asialoglycoprotein receptors (ASGPR) on liver parenchymal cells. Palmitoylated AG (PAG) was characterized by physico-chemical parameters, IR, (1)H NMR, and (13)C NMR and molecular weight determination by gel permeation chromatography. PAG was incorporated in liposomes and the liposomes were characterized by dynamic light scattering, optical microscopy, zeta potential, and transmission electron microscopic (TEM) techniques. The liposomal system was evaluated for acute toxicity in swiss albino mice and was found to be safe. Targeting ability of PAG was confirmed by in vitro binding affinity to Ricinus communis agglutinin (RCA(120)), a lectin specific for galactose. The liposomal system with PAG was evaluated for cytotoxicity on HepG2, MCF7, and A549 cancer cell lines. Cytotoxicity study revealed enhanced activity on ASGPR-expressive HepG2 cells as compared to MCF7., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Context: The red algae Gelidium crinale (Turner) Gaillon (Gelidiaceae), encountered along the Southeast and Northeast Brazilian sea coast, contains a sulfated galactan presenting a similar saccharide backbone compared to λ carrageenan. Inflammatory effects of other galactans were reported, but not for that obtained from G. crinale (SG-Gc)., Objective: To investigate the in vivo edematogenic effect of SG-Gc in comparison to λ carrageenan., Methods: SG-Gc was isolated by ion exchange chromatography. Paw edema was induced by subcutaneous (s.c.) intraplantar injection of SG-Gc or λ carrageenan and evaluated by hydroplethysmometry. Data were expressed as the increase in paw volume subtracted from the basal volume or area under curve-AUC. To investigate the participation of early and late-phase inflammatory mediators, rats were treated with pyrilamine, compound 48/80, indomethacin, NG-nitro-L-arginine methyl ester (L-NAME), or pentoxifylline before SG-Gc., Results: SG-Gc edematogenic effect was initiated at 0.5 h, peaked at 2 h (1.26 ± 0.05 mL) and lasted until 6 h (0.21 ± 0.03 mL), whereas the carrageenan-induced edema started at 1 h. The first phase (1-3 h) of SG-Gc-induced edema was 176 ± 15 (AUC) versus carrageenan (114.5 ± 14), whereas the second phase (3-5 h) was 95 ± 12 (AUC) versus carrageenan (117.5 ± 11). Treatment with compound 48/80, pyrilamine, indomethacin, L-NAME, and pentoxifylline inhibited the effect of SG-Gc by 32, 40, 69, 72, and 49%, respectively., Discussion and Conclusion: SG-Gc and λ carrageenan induce different profile of inflammatory response in the paw edema model, that involves histamine, cytokines, prostaglandins, and nitric oxide (NO), but with different degree of participation.

Introduction: Prebiotics positively affect gut microbiota composition, thus improving gut function. These properties may be useful for the treatment of constipation., Objectives: This study assessed the tolerance and effectiveness of a prebiotic inulin/partially hydrolyzed guar gum mixture (I-PHGG) for the treatment of constipation in females, as well as its influence on the composition of intestinal microbiota and production of short chain fatty acids., Methods: Our study enrolled 60 constipated female health worker volunteers. Participants reported less than 3 bowel movements per week. Volunteers were randomized to treatment with prebiotic or placebo. Treatment consisted of 3 weeks supplementation with 15 g/d IPHGG (fiber group) or maltodextrin (placebo group). Abdominal discomfort, flatulence, stool consistency, and bowel movements were evaluated by a recorded daily questionnaire and a weekly interview. Changes in fecal bacterial population and short chain fatty acids were assessed by real-time PCR and gas chromatography, respectively., Results: There was an increased frequency of weekly bowel movements and patient satisfaction in both the fiber and placebo groups with no significant differences. Total Clostridium sp significantly decreased in the fiber group (p = 0.046) and increased in the placebo group (p = 0.047). There were no changes in fecal short chain fatty acid profile., Conclusions: Consumption of I-PHGG produced clinical results comparable to placebo in constipated females, but had additional protective effects on gut microbiota by decreasing the amount of pathological bacteria of the Clostridium genera.

Background/aims: In the present study, we aimed to investigate if partially hydrolyzed guar gum (PHGG) can be used safely as a fiber source for treatment of constipation in children and to compare its success with the most commonly used osmotic laxative, lactulose., Methods: A randomized prospective controlled study on 61 patients (partially hydrolyzed guar gum group, n: 31; lactulose group, n: 30) was performed. Patients were given lactulose or partially hydrolyzed guar gum for four weeks. Using a standardized bowel diary, defecation frequency, stool consistency, and presence of flatulence and abdominal pain were recorded. Family questionnaires about the success, safety and side effect profile of both treatment arms were also obtained., Results: No significant differences were found in the baseline daily fiber (fruits and vegetables) intake between the two groups. Bowel movement frequency per week and stool consistency improved significantly in both treatment groups (p<0.05). The percent of children with abdominal pain and stool withholding also decreased eminently in both groups (p<0.05). Weekly defecation frequency increased from 4±0.7 to 6±1.06 and from 4±0.7 to 5±1.7 in the lactulose and partially hydrolyzed guar gum treated groups, respectively (p<0.05). According to the family questionnaire, the parents complained of bad taste, flatulence and necessity to ingest a high amount of drug in the lactulose treatment group. In the partially hydrolyzed guar gum treatment group, parents were satisfied with the defecation frequency of their children., Conclusions: Treatment with partially hydrolyzed guar gum is as effective as lactulose treatment in relieving stool withholding and constipation-associated abdominal pain, and its use improves stool consistency. Lactulose seemed to have more side effects, including flatulence and sensation of bad taste.

A sulfated galactan (FG) was isolated from the green alga, Codium fragile. Chemical analysis revealed that FG mainly consisted of D-galactose with pyruvic acid (12.3%) and sulfate (11.0%). Methylation and NMR analyses showed that FG was composed of -->3)-beta-D-Galp-(1-->, beta-D-Galp-(1--> and -->3,6)-beta-D-Galp-(1--> residue. In addition, pyruvic acid was suggested to be present as (1'-carboxy)-ethylidene cyclic ketal at O-3 and O-4 of non-reducing terminal galactose residues, whereas sulfate was substituted at O-4 of other galactose residues. When the antiviral potency of FG was evaluated, it inhibited the replication of herpes simplex virus type 2 (HSV-2), and the mechanism of action was suggested to be interference in the early steps such as virus adsorption to and penetration into host cells. Furthermore, it was shown that FG directly reduced virus infection rates. In a genital infection model using HSV-2-infected mice, FG improved mortality and lesion scores and reduced virus yields by intravaginal administration. These results suggest that FG might be a potent candidate as a prophylactic agent for HSV-2 infection.

We compared sulfated galactans (SGs) from two species of red algae using specific coagulation assays and experimental models of thrombosis. These polysaccharides have an identical saccharide structure and the same size chain, but with slight differences in their sulfation patterns. As a consequence of these differences, the two SGs differ in their anticoagulant and venous antithrombotic activities. SG from G. crinale exhibits procoagulant and prothrombotic effects in low doses (up to 1.0 mg/kg body weight), but in high doses (>1.0 mg/kg) this polysaccharide inhibits both venous and arterial thrombosis in rats and prolongs ex-vivo recalcification time. In contrast, SG from B. occidentalis is a very potent anticoagulant and antithrombotic compound in low doses (up to 0.5 mg/kg body weight), inhibiting venous experimental thrombosis and prolonging ex-vivo recalcification time, but these effects are reverted in high doses. Only at high doses (>1.0 mg/kg) the SG from B. occidentalis inhibits arterial thrombosis. As with heparin, SG from G. crinale does not activate factor XII, while the polysaccharide from B. occidentalis activates factor XII in high concentrations, which could account for its procoagulant effect at high doses on rats. Both SGs do not modify bleeding time in rats. These results indicate that slight differences in the proportions and/or distribution of sulfated residues along the galactan chain may be critical for the interaction between proteases, inhibitors and activators of the coagulation system, resulting in a distinct pattern in anti- and procoagulant activities and in the antithrombotic action.

Sulfated galactan from the red alga Botryocladia occidentalis has a potent anticoagulant activity, due to its ability to enhance thrombin and factor Xa inhibition by antithrombin and/or heparin cofactor II. It is less active than unfractionated heparin in arterial thrombosis, but in a venous thrombosis presents a dual effect, inhibiting thrombosis in low but not in high doses. This dual effect on venous thrombosis is a consequence of two actions, one that inhibits thrombin and factor Xa and one that induces factor XII activation. In order to dissociate these effects, we prepared derivatives of the sulfated galactan with low molecular weights. Two fractions that were similar in size to unfractionated heparin and low-molecular-weight heparin were obtained. As the molecular weight decreased, the ability to activate factor XII and to promote inhibition of coagulation proteases in the presence of antithrombin and heparin cofactor II diminished. At approximately 5 kDa, the sulfated galactan fragment had no effect on factor XII activation, and showed the same effect as unfractionated heparin in a venous thrombosis model. The approximately 5-kDa fragment is an antithrombotic with several advantages: i) It is as active as unfractionated heparin in venous thrombosis, but it has little activity in arterial thrombosis; ii) It inhibits venous thrombosis with very little anticoagulant effect; iii) It does not cause bleeding; and iv) It is not obtained from mammals.

In the setting of a six-month, open-label clinical trial, 141 consecutively enrolled, hypertensive, overweight patients were randomized to the oral ingestion of psyllium powder or guar gum 3.5 gr t.i.d., to be taken 20 min before the main two meals, or to standard diet. Both fibers improved significantly BMI, FPG, FPI, HOMA Index, HbA1c, LDL-C, and ApoB. Psyllium supplementation only exerted a significant improvement in plasma TG concentration, in SBP and DBP. In our study, six-month supplementation with psyllium fiber, but not with guar fiber nor standard diet, appears to significantly reduce both SBP and DBP in hypertensive overweight subjects.

We report the first case of a life-threatening immediate-type hypersensitivity caused by Dynexan, a local anaesthetic gel. After mucosal application by his dentist, a 63-year-old man rapidly developed urticaria, dyspnea and, at last, he collapsed and remained unconscious for 2 hr despite emergency care. While the standard prick tests were negative to all local anaesthetics tested including lidocaine, a 1-fold positive reaction was detected to Meyprogat 60, an ingredient of Dynexan. As the gelling agent Meyprogat represents a derivative of guar (synonymous guar gum, guaran, E-412), we subsequently tested different guar products derived from Cyamopsis tetragonoloba beans and, as control, the closely related locust bean gum E-410. In the prick-to-prick tests, the guar-derived food additive Provigel NAG 905 provoked a 1-fold positive reaction. Native guar beans pounded and resuspended in water showed a 2-fold positive reaction, whereas no reaction was found to derivatives of locust bean gum. Specific immunoglobulin E were negative in all cases. Despite the common use of guar as versatile food additive or gelling agent, this is the first case of a severe immediate-type hypersensitivity after mucosal contact.

A novel induced viscosity fiber (IVF) crispy bar was formulated with the viscous dietary fibers alginate and guar gum. To evaluate the glycemic response and gastrointestinal tolerance to IVF crispy bars, nondiabetic healthy adult subjects (n = 48) were studied in a randomized, double-masked, crossover design. The control crispy bars and IVF crispy bars were identical except for the 2 dietary fibers contained in the experimental (IVF) bars. After an overnight fast, subjects consumed test bars containing 50 g carbohydrate. Their capillary blood glucose response was determined for 180 min postprandially. When subjects consumed IVF, the incremental blood glucose excursions were reduced (P < 0.05) at 15, 30, 45, and 120 min. At 180 min, the subjects' blood glucose concentration was maintained above the basal blood glucose concentration for both bars. Compared with controls, the incremental peak blood glucose concentration was reduced (P < 0.001) 30% when subjects consumed IVF. When subjects consumed IVF, the positive incremental area under the curve for glucose was reduced (P < 0.01) by 33% compared with controls. In the 24-h postprandial period after each treatment, the frequency and intensity of gastrointestinal tolerance symptoms did not differ. In conclusion, compared with a control crispy bar, the IVF crispy bar attenuated the postprandial glycemic excursion without gastrointestinal intolerance in healthy adult subjects.

Objective: This paper provides a review of research on partially hydrolyzed guar gum that is relevant to clinical nutrition practice., Methods: All relevant papers published on partially hydrolyzed guar gum were reviewed and the results summarized., Results: Partially hydrolyzed guar gum (PHGG) is a water-soluble dietary fiber with a wide range of uses in clinical nutrition. Its low viscosity allows its use in enteral products and beverages. PHGG can be added to enteral formulas and food products as a dietary fiber source. PHGG provides the benefits associated with dietary fiber ingestion. Addition of PHGG to the diet reduced laxative dependence in a nursing home population. PHGG also reduced the incidence of diarrhea in septic patients receiving total enteral nutrition and reduced symptoms of irritable bowel syndrome. PHGG also increased production of Bifidobacterium in the gut., Conclusion: The ease of use of PHGG and its clinical effectiveness make it a good choice in clinical nutrition practice.

Unlabelled: The immunomodulating effects of two Echinacea species, E. purpurea and E. angustifolia and larch arabinogalactan extracted from Larix occidentalis were examined in a randomized, double-blind, placebo-controlled, prospective four-week clinical trial at a naturopathic medical school research center., Subjects/materials: Forty-eight healthy female volunteers (22-51 y) were randomly assigned to one of six groups: standardized extract of E. purpurea (EP); ultra-refined E. purpurea/E. angustifolia (urEPA); E. purpurea/E. angustifolia (EPA); E. purpurea/E. angustifolia plus larch arabinogalactan (EPALA); larch arabinogalactan (LA); or placebo., Methods: Immunological tests with enumerative measurements, stool cultures for Lactobacillus acidophilus and yeast, and health-related quality of life (HRQoL) using the Medical Outcomes Study derived SF-36 self-administered questionnaire were assessed at baseline and at four weeks., Results: Complement properdin increased by 21 percent in the EPA group (p<0.05) and by 18 percent in the EPALA group (p<0.05), compared to the placebo group (p>0.05). SF-36 showed improvements in overall physical health, vitality, and emotional health in the same two groups (EPA and EPALA)., Discussion: Volunteers in the EPA and EPALA groups had increased production of complement properdin after four weeks of intervention. The increased complement properdin may be an indication of one aspect of immune system stimulation in patients treated with either E. purpurea/E. angustifolia or E. purpurea/E. angustifolia plus larch arabinogalactan.

Purpose: To determine the efficacy of the dietary fiber guar gum as a therapeutic option for reducing body weight by conducting a meta-analysis of randomized controlled trials., Methods: Literature searches were performed on the electronic databases Medline, Embase, Biosis, Amed, and the Cochrane Library. Manufacturers of commercial guar gum preparations and experts on the subject were contacted to provide any published or unpublished trials. For inclusion, trials had to state that they were randomized, double blinded, and placebo controlled, used guar gum monopreparations, and reported body weight as an endpoint. No language restrictions were imposed. Two reviewers independently extracted data in a standardized manner according to predefined criteria and evaluated methodological quality using the scoring system developed by Jadad. Discrepancies were settled through discussion., Results: Thirty-four trials were identified and 20 could be included. Eleven trials provided data that were suitable for statistical pooling. The meta-analysis indicated a nonsignificant difference in patients receiving guar gum compared with patients receiving placebo (weighted mean difference -0.04 kg; 95% confidence interval (CI): -2.2 to 2.1). Analysis of six trials with similar methodologic features corroborates these findings (weighted mean difference -0.3 kg; 95% CI: -4.0 to 3.5). Adverse events most frequently reported were abdominal pain, flatulence, diarrhea, and cramps. Overall, 11 patients (3%) dropped out owing to adverse events., Conclusions: This meta-analysis suggests that guar gum is not efficacious for reducing body weight. Considering the adverse events associated with its use, the risks of taking guar gum outweigh its benefits for this indication. Therefore, guar gum cannot be recommended as a treatment for lowering body weight.

Larch arabinogalactan is a polysaccharide powder derived from the wood of the larch tree (Larix species) and comprised of approximately 98 percent arabinogalactan. Arabinogalactans are found in a variety of plants but are more abundant in the Larix genus, primarily Larix occidentalis (Western Larch). The Western Larch is unique among pines in that it loses its needles in the fall. Western Larch is also known as Mountain Larch or Western Tamarack and is native to the Pacific and Inland Northwest United States as well as parts of British Columbia, Canada. Larch arabinogalactan is approved by the U.S. Food and Drug Administration (FDA) as a source of dietary fiber, but also has potential therapeutic benefits as an immune stimulating agent and cancer protocol adjunct.

This study evaluated the effects of adding soluble fibre to the diet of healthy weaner pigs and weaner pigs experimentally infected with enterotoxigenic Escherichia coli (ETEC) in a model of post-weaning colibacillosis. Bodyweight gain, intestinal changes and proliferation of ETEC were measured 7 days following weaning. The basal diet consisted of pregelatinised rice fortified with animal protein. Addition of guar gum to this diet elevated the soluble fibre content from 1 to 6 per cent, and was associated with reduced bodyweight gains, increased large intestinal weights and fermentation, and increased proliferation of ETEC in the small intestine. The optimal levels and type of dietary fibre used for weaner pig diets require further evaluation., (Copyright 1999 Harcourt Publishers Limited.)

Hypercholesterolaemia is one of the major risk factors in the development of coronary artery disease. In recent years, many nonprescription treatments have become available for cholesterol lowering. Minolest is a product that contains guar gum and psyllium as the principal active ingredients. We conducted a randomised, placebo-controlled, double-blind, parallel-group study to assess the efficacy of Minolest as a lipid-lowering agent. Secondary aims included assessment of the effect on blood pressure and obesity. We also looked at the acceptability of the product and side effects associated with its ingestion. After a 4-week run-in period, 83 subjects were randomised to receive placebo or Minolest (16.5 g/day) for 3 months. Seven subjects defaulted follow up, 5 in the placebo group and 2 in the active treatment group. In addition, 9 subjects (5 on active treatment and 4 on placebo) had total cholesterol fall into the optimal range (< 5.2 mmol/l) during the run-in phase and were removed from the study. At baseline in the active treatment group, total cholesterol was 6.1 (5.43 to 8.06) mmol/l, triglyceride 1.54 (0.56 to 4.19) mmol/l, HDL cholesterol 1.32 +/- 0.43 mmol/l and LDL cholesterol 4.1 (3.10 to 6.27) mmol/l. In the placebo group, total cholesterol was 5.84 (5.32 to 8.38) mmol/l, triglyceride 1.47 (0.69 to 11.0) mmol/l, HDL cholesterol 1.15 +/- 0.33 mmol/l and LDL cholesterol 3.87 (2.46 to 5.14) mmol/l. The differences in the baseline characteristics were not statistically significant except the LDL-cholesterol. Minolest produced a 3.24% (SD = 7.85%, P = 0.020) decrease in total cholesterol and 5.45% decrease in LDL cholesterol (SD = 10.25%, P = 0.0034) but no significant difference in serum triglyceride, weight, body mass index or blood pressure. This was not seen in the placebo group. The percentage fall in LDL cholesterol increased to 7.16% and 7.37% in subjects who consumed at least 50% and 70% of the treatment respectively. There were few side effects. The authors conclude that this product has a small impact on the lipid profile and may be useful only in subjects with mild hypercholesterolaemia and a low risk of coronary artery disease.

Background: Subjects with occupational asthma (OA) often report nasal symptoms, but nasal reactions to inhalation challenges with occupational agents have not been well characterized., Methods: Fifteen subjects with OA (eight due to high-molecular-weight agents--flour and guar gum--and seven due to isocyanates) underwent inhalational challenges using closed-circuit devices (dry particles for high-molecular-weight agents and gas generator for isocyanates) on two occasions, 2-4 weeks apart in a random fashion. On one occasion, they inhaled through the nose and, on another, through the mouth. The FEV1 was monitored for up to 8 h afterward, and symptoms were documented with a standardized questionnaire on nasal symptomatology, assessment of nasal resistance by rhinomanometry, and nasal lavage for the examination of cells and mediators., Results: Inhaling through the mouth and through the nose: 1) yielded similar asthmatic responses (25+/-8% and 22+/-10% maximum changes in FEV1) 2) more than doubled the peak nasal symptoms and nasal resistance when the maximum daily response was compared with prechallenge results. This increase occurred on the days of inhalational challenges through the mouth and through the nose. There were some significant responses assessed by nasal lavage in terms of cells and mediators, again with no differences between the days of challenges through the mouth and through the nose., Conclusions: Inhaling occupational agents of high or low molecular weight, including isocyanates, whether through the mouth or nose: 1) results in a similar asthmatic response 2) causes a significant nasal response in terms of symptoms and an increase in nasal resistance 3) causes some significant changes in inflammatory cells and mediators.

The study was undertaken to assess the efficacy guargum, Acarbose and their combination in modifying the sucrose absorption in patients of non Insulin dependent diabetes mellitus (NIDDM). Fifty patients of NIDDM were randomly distributed in three groups. Group A had 20 patients who received 20 grams of guargum, Group B had 10 patients who received 100 mg of Acrabose, Group C had 20 patients who received 10 grams of guargum and 50 grams of Acrabose. All the patients underwent 50 grams sucrose tolerance test with and without the trial drugs. Blood glucose levels were determined at 0, 30, 60, 90 and 120 minutes after sucrose loading. With the drugs, there was a significant decrease in the blood glucose levels at all time intervals (p < 001) in all the three groups. In all the three groups the blood glucose levels with the trial drugs was significantly lower (p < 001) than without the drug. It was seen that acarbose alone and guargum alone did not differ significantly in reducing the blood sugar level whereas combination of two produced significantly greater reduction in blood glucose levels than either of the drug used alone. Thus both guargum and acarbose are equally effective in modifying the absorption of sucrose. When combined in half the dosage they have synergistic effect and the reduction in blood glucose level is greater than either of the drug used alone.

Twenty-six domestic reports of suspected adverse reactions from the guar gum-containing diet pill, Cal-Ban 3000 (filed with the FDA) were reviewed. There were 18 instances of esophageal obstruction, seven instances of small bowel obstruction, and one individual who was reported to have died after ingestion of Cal-Ban 3000, but for whom insufficient details were provided to assess causation. There were 14 women and 11 men (mean age 46.3 yr; range 17 to 67 yr) for whom sufficient information was available. Preexisting esophageal or gastric disorders were present in 50% of those with esophageal obstruction, including peptic stricture, pyrosis, hiatal hernia, esophagitis, gastric stapling procedure, Schatzki ring, and muscular dystrophy. Fourteen of these 18 patients with esophageal obstruction were treated successfully by endoscopy, although the tenacious gel-like consistency of the material was often difficult to remove. Two patients required rigid esophagoscopy when flexible endoscopy was unsuccessful. This resulted in the death of one patient who developed a pulmonary embolism after surgical repair of an intraoperative esophageal tear. For the seven patients with small bowel obstruction, no specific predisposing factors were mentioned. One individual required exploratory laparotomy, and inspissated tablets were found in the ileum. These cases, spontaneously reported to the FDA, are very similar to those reported in the literature. The water-holding capacity and gel-forming tendency of guar gum permits it to swell in size 10- to 20-fold, and may lead to luminal obstruction, especially when an anatomic predisposition exists. Such products have been banned in Australia, and Cal-Ban 3000 has recently been removed from the market in the United States. However, unsuspecting patients who are still in possession of the product should be apprised of the potential complications that may arise with its use.

Background: The effect on colonic cell proliferation of poligeenan, a nongenotoxic polysaccharide that induces colon tumors in rats, was compared with guar gum and carrageenan., Experimental Design: Fischer 344 rats were fed a basal diet supplemented with carrageenan and poligeenan fibers for up to 91 days. The quantitative levels of proliferation, location of the proliferating cells, and the ability of the mucosa to readapt by removing the experimental fibers from the diet were tested., Results: The mucosal epithelium exhibited a 5-fold increase in thymidine kinase activity in both the carrageenan and poligeenan groups. Proliferating cells appeared at the luminal surface only in the poligeenan-treated rats, and the number of proliferating cells in the upper third of the crypt increased 35-fold. A second and third set of animals were fed one of the three test diets for either 28 or 64 days, followed by a 28-day recovery period. Proliferation in the guar- and carrageenan-treated groups returned to basal levels. In poligeenan-treated rats, thymidine kinase levels, and proliferating cells in the upper third of the crypt remained 2- and 11-fold, respectively, above controls., Conclusions: The difference in recovery time between the poligeenan group and the others, and the luminal location of proliferating cells may prove useful as markers in understanding early events in the carcinogenic process induced by a nongenotoxin.

Guar gum is a high polymer carbohydrate that undergoes considerable expansion and thickening when placed in water. Because of this property, guar gum has been used in "weight loss" tablets marketed by several pharmaceutical manufacturers. These tablets undergo expansion in the stomach and are expected to cause early satiety. Patients with esophageal disorders should be cautioned against the use of this product because it may expand in the esophagus and create an obstruction.

Sixty-two patients (34 men and 28 women) aged 19-64 years, half of whom had familial hypercholesterolemia, treated initially for 18 weeks with lovastatin alone were randomly allocated either to lovastatin (L) and cholestyramine (16 g/day) or lovastatin and guar gum (L + GG 20 g/day) treatment for 18 additional weeks to compare the hypocholesterolemic effects of these two combination therapies. The patients were selected for this study from a larger study of patients (n = 120) with severe hypercholesterolemia [serum total cholesterol (serum Chol) 6.5-16.3 mM before treatment], and only those patients in whom serum Chol after lovastatin alone (dose 80 mg/day) remained greater than or equal to 5.2 mM were eligible for evaluation of combination therapies. Serum Chol decreased from 10.6 +/- 1.6 to 5.9 +/- 1.3 mM (mean +/- SD) (p less than 0.001) and low-density lipoprotein cholesterol (LDL Chol) from 8.5 +/- 1.8 to 4.1 +/- 1 mM (p less than 0.001) in patients treated with L + GG (values before the beginning of lovastatin and at the end of the combination therapy). The respective changes were from 10.9 +/- 2.2 to 5.5 +/- 1.2 mM (p less than 0.001) and from 8.7 +/- 2.3 to 3.5 +/- 1.2 mM (p less than 0.001) in patients treated with lovastatin and cholestyramine (L + C). At the end of the study, both serum Chol (p less than 0.005) and LDL Chol (p less than 0.01) were significantly lower with L + C than with L + GG.(ABSTRACT TRUNCATED AT 250 WORDS)

Supplements consisting primarily of dietary fibers are marketed as aids to weight reduction. Of uncertain efficacy, they have generally been regarded as safe when used according to directions. We report two cases of acute esophageal obstruction by a guar gum product in patients with preexisting esophageal abnormalities and review similar reports from other centers.