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Dental caries and periodontal disease are wide-spread oral illnesses whose etiology is intimately associated with the consumption of carbohydrate sweeteners....Human clinical trials and several animal experiments have shown promising clinical results obtained by replacing sucrose with certain sugar alcohols (polyols). Among the sugar alcohols, the best results so far have been obtained with xylitol, which is chemically a pentitol containing five carbon atoms. Chewing gums containing xylitol have been shown to be strong instruments against caries in caries-active age-groups and in high-risk subjects. More research is needed to assess the ability of mixtures of xylitol with sorbitol, palatinit, maltitol, other sugar alcohols, and intense sweeteners to prevent oral plaque diseases. Although thorough clinical trials on the relationship between carbohydrate sweeteners and periodontal diseases have not been performed, the available data indicate that dietary polyols may have a restricted dampening effect on periodontal and gingival inflammations.

/HUMAN EXPOSURE STUDIES/ The polyol isomalt (Palatinit) is a well established sugar replacer. The impact of regular isomalt consumption on metabolism and parameters of gut function in nineteen healthy volunteers was examined in a randomised, double-blind, cross-over trial with two 4-week test periods. Volunteers received 30 g isomalt or 30 g sucrose daily as part of a controlled diet. In addition to clinical standard diagnostics, biomarkers and parameters currently discussed as risk factors for CHD, diabetes or obesity were analysed. Urine and stool Ca and phosphate excretions were measured. In addition, mean transit time, defecation frequency, stool consistency and weight were determined. Consumption of test products was affirmed by the urinary excretion of mannitol. Blood lipids were comparable in both phases, especially in volunteers with hyperlipidaemia, apart from lower apo A-1 (P=0.03) for all subjects. Remnant-like particles, oxidised LDL, NEFA, fructosamine and leptin were comparable and not influenced by isomalt. Ca and phosphate homeostasis was not affected. Stool frequency was moderately increased in the isomalt phase (P=0.006) without changes in stool consistency and stool water. This suggests that isomalt is well tolerated and that consumption of isomalt does not impair metabolic function or induce hypercalciuria. ...

/HUMAN EXPOSURE STUDIES/ Isomalt, placebo, sorbitol, or sucrose (20 g dissolved in 200 mL water in the case of the placebo or 2 tablets of Natreen dissolved in the same amount of water) was administered to 24 type I diabetics at 6 a.m., 10 a.m., 2 p.m., and 6 p.m. Each test substance was administered 6 times at each of these 4 periods. Average and maximum serum insulin levels and average and maximum blood sugar levels were significantly higher after sucrose ingestion than after ingestion of the other test substances. There were no significant differences between sorbitol and isomalt. Side effects reported after isomalt ingestion included vomiting in one patient, but diarrhea was not reported with any of the test substances.

/HUMAN EXPOSURE STUDIES/ During a double-blind test, 12 volunteers ingested sorbitol, and 12 others isomalt, in 10, 20, or 40 g doses administered in 1-2 week intervals. The internal neurological and cardiovascular examinations, as well as hematology and blood chemistry analyses, revealed no modifications in initial data or values which could be related to the intake of either of the 2 sugar substitutes. The intestinal symptoms (meteorism, flatulence, and diarrhea) increased as the administered dose-strength increased. After 10 g of either substance, light abdominal pains were registered; after 20 g, these symptoms became stronger, and flatulence and diarrhea occurred; the 10 patients having indicated no symptoms were equally divided between the 2 test groups. From a clinical viewpoint, intestinal symptoms were significantly higher in those volunteers given 40 g isomalt or sorbitol, which represents the normal consumption level of a sugar substitute, than in the other groups. The differences in response to isomalt and sorbitol were not significant.

/HUMAN EXPOSURE STUDIES/ In a double-blind cross-over study, 200 healthy adult volunteers of both sexes received 50 g chocolate containing either 20 g isomalt or 20 g sucrose at 8 o'clock in the morning after a standard breakfast at intervals of 1 week. After isomalt ingestion, 16 of the volunteers (8%) reacted with diarrhea, whereas none experienced diarrhea after sucrose ingestion. The incidence of diarrhea was 10.8% in female volunteers versus only 4.5% in male volunteers. The subjects had been informed of the possible gastrointestinal symptoms in advance, so it is possible that the expectations of the female volunteers and also their subjective evaluation of the resulting symptoms were different than those of the male volunteers. A higher frequency of defecation and increased flatulence were reported after isomalt ingestion compared with the ingestion of sucrose.

For more Human Toxicity Excerpts (Complete) data for Isomalt (34 total), please visit the HSDB record page.

/LABORATORY ANIMALS: Acute Exposure/ In other dietary studies, 10% isomalt caused transient diarrhea that disappeared after adaptation; the feeding of isomalt was associated with cecal enlargement.

/LABORATORY ANIMALS: Acute Exposure/ Fistulated and normal pigs were fed 10% sucrose between meals, 5 or 10% isomalt between meals, or 10% isomalt with meals. The passage and absorption rate of these substances were determined at the terminal ileum (10 pigs per treatment) or over the whole distance of the digestive tract (4 pigs per treatment). ... No influence of isomalt on the consistency of the feces was observed. An increased flow of ileum chyme occurred in the period of 1-4 hours after administration of isomalt, which is probably related to the osmotic activity of non-absorbed isomalt and its constituents. Consequently, the ileal digestibility of the proteins of the basal diet was slightly negatively affected. The fecal digestibility of energy-containing compounds in the isomalt treatments was significantly lower than in sucrose treatment. This can be explained by the increased excretion of bacterial mass resulting from the more intensive fermentation in the large intestine in the isomalt-fed groups. The results of the determination of metabolisable energy of the diets indicate that the metabolisable energy value of isomalt is lower than that of sucrose.

/LABORATORY ANIMALS: Acute Exposure/ Groups of 12 ileum re-entrant fistulated pigs and 12 normal pigs (Dutch Landrace x large white) were fed 80% basal ration plus a combination of 10% isomalt and 10% sucrose, 20% isomalt, or 20% sucrose. After exposure to isomalt for 5 and 8 days, no isomalt could be detected in the feces. ... In pigs fed 10%, and especially 20%, isomalt, the flow of the chyme along the small intestine was considerably accelerated during the first 3-4 hours after feeding, and the amount of chyme appearing at the terminal ileum was greatly increased compared with the animals fed 20% sucrose. This accelerated and increased flow of the chime along the small intestine was ascribed by the authors as most likely due to the osmotic properties of the non-absorbed isomalt and its constituents. Fecal digestibility of proteins and "nitrogen-free extract" in the 10%, and especially the 20%, isomalt diets was depressed compared with the 20% sucrose diet. As a result, energy digestibility with the isomalt diets was also depressed. The authors concluded that the lowered faecal digestibility of the isomalt diets is most likely due to the increased excretion of bacterial mass resulting from the more intensive fermentation in the large intestine in the isomalt-fed groups.

/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Groups of 4 male and 4 female beagle dogs, 40-51 weeks of age, received isomalt at dietary concentrations of 0, 5, 10, or 20% for 13 weeks. No differences between control and test groups were observed in general behavior or appearance; food intake and body weights were normal. Diarrhea was observed in animals receiving 20% isomalt and, occasionally, in the 10%-dose group; normal feces were produced by animals given 5% isomalt. Measurement of body temperatures, pulse rates, and reflexes and ophthalmoscopic investigations after 4, 7, and 13 weeks of treatment showed no treatment-related changes; hematological and clinical chemical parameters were normal at these times. Plasma urea concentrations were lower in the treated animals, sometimes significantly so, but still within the range considered physiologically normal. Urinalysis did not show treatment-related differences. At autopsy, no compound-dependent abnormalities were observed and organ weights were unaffected (the gastrointestinal tract components were not weighed). Histopathological examination did not detect any tissue changes related to the test material. Concentrations of intestinal tissue alpha-glucosidases (maltase, sucrase, and glucoamylase) were unchanged by treatment. The authors concluded that concentrations of up to 20% isomalt in the diet did not produce any toxic injury. Allowing for the occasional ill-formed feces in the 10%-dose group, the no-effect level was conservatively placed at 5% of the diet, equal to 1.67 g/kg b.w./day for 13 weeks.

/SRP:/ Immediate first aid: Ensure that adequate decontamination has been carried out. If patient is not breathing, start artificial respiration, preferably with a demand-valve resuscitator, bag-valve-mask device, or pocket mask, as trained. Perform CPR as necessary. Immediately flush contaminated eyes with gently flowing water. Do not induce vomiting. If vomiting occurs, lean patient forward or place on left side (head-down position, if possible) to maintain an open airway and prevent aspiration. Keep patient quiet and maintain normal body temperature. Obtain medical attention. /Higher alcohols (>3 carbons) and related compounds/

/SRP:/ Basic Treatment: Establish a patent airway (oropharyngeal or nasopharyngeal airway, if needed). Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if necessary. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for shock and treat if necessary ... . Monitor for pulmonary edema and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with 0.9% saline (NS) during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 ml/kg up to 200 ml of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool. Administer activated charcoal ... . /Higher alcohols (>3 carbons) and related compounds/

/SRP:/ Advanced Treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in severe respiratory distress. Positive-pressure ventilation techniques, with a bag-valve-mask device, may be beneficial. Consider drug therapy for pulmonary edema ... . Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start IV administration of D5W /SRP: "To keep open", minimal flow rate/. Use 0.9% saline (NS) or lactated Ringer's (LR) if signs of hypovolemia are present. For hypotension with signs of hypovolemia, administer fluid cautiously. Consider vasopressors if patient is hypotensive with a normal fluid volume. Watch for signs of fluid overload ... . Monitor for signs of hypoglycemia (decreased LOC, tachycardia, pallor, dilated pupils, diaphoresis, and/or dextrose strip or glucometer readings below 50 mg) and administer 50% dextrose if necessary ... . Treat seizures with diazepam or lorazepam ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Higher alcohols (>3 carbons) and related compounds/

LD50 Rat i.p. > 2,500 mg/kg b.w.

LD50 Rat i.v. > 2,500 mg/kg b.w.

Food labeling. Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries. ... Eligible noncariogenic carbohydrate sweeteners are the sugar alcohols xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, and erythritol, or a combination of these.

CIR ingredient: Isomalt

Isomalt is a noncariogenic excipient used in a variety fo pharmaceutical preparations including tablets or capsules, coatings, sachets, suspensions, and in effervescent tablets. It can also be used in direct compression and wet granulation. In buccal applications such as chewable tablets it is commonly used because of its negligible negative heat of solution, mild sweetness and 'mouth feel'. It is also used widely in lozenges, sugar-free chewing gum, and hard-boiled candies, and as a sweetening agent in confectionery for diabetics.

Sugar substitute for most applications in confectionery

Applications in the nonfood sector (e.g., surfactant synthesis and resin production) are known.

On catalytic hydrogenation /of isomaltulose/, isomalt is obtained as an approximately equimolar mixture of both isomers. Industrially hydrogenation is carried out as a fixed-bed process in the presence of nickel catalysts. After hydrogenation and complete deionization, isomalt is obtained as an agglomerate of the two isomalt components by using a specially developed drying process. The agglomerates consist of discrete crystallites of GPM /1-O-alpha-D-glucopyranosyl-D-mannitol/ dihydrate, anhydrous GPM, and 1,6-GPS /6-O-alpha-D-glucopyranosyl-D-sorbitol/ with a primary crystal-size distribution of < 1 um. In processing, agglomerates about 0.2-2 mm in size behave like homogeneous crystallites. The isomalt components have a high tendency to crystallize (low solubility at low temperature). An isomalt variant which is enriched in 1,6-GPS could be obtained by enhanced crystallization techniques. Isomalt is commercially available either as crystalline product or as a concentrated liquid solution.

Food additives

Food Additives -> ANTICAKING_AGENT; BULKING_AGENT; GLAZING_AGENT; SWEETENER -> JECFA Functional Classes

Food Additives -> ANTICAKING_AGENT; BULKING_AGENT; GLAZING_AGENT; SWEETENER -> JECFA Functional Classes

Cosmetics -> Humectant

Table of percent relative sweetness and caloric values: [Table#7893]

A mixture of diasteromers 6-O-apha-D-glucopyranosul-D-sorbitol and 1-O-alpha-D-glucopyranosyl-D-mannitol

... Sweetening power = 0.45 relative to sucrose in about 10% solution.