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Isomaltulose

Isomaltulose, also known as palatinose, is a naturally occurring reducing disaccharide composed of a glucose unit linked to a fructose unit via an α-1,6 glycosidic bond, with the chemical name 6-O-α-D-glucopyranosyl-D-fructofuranose and a molecular weight of 360.3. It appears as a white, crystalline powder with a melting point of 122–124°C, solubility in water that increases with temperature (about 85% of sucrose at 80°C), and a sweetness level approximately 48–50% that of sucrose. Found in trace amounts in honey (0.1–1%) and sugarcane juice, isomaltulose is valued for its low glycemic index of 32, which results from slower enzymatic hydrolysis in the small intestine compared to sucrose, leading to a more gradual release of glucose and fructose. Commercially, isomaltulose is produced through the enzymatic of food-grade using the sucrose-6-glucosylmutase derived from the non-pathogenic bacterium Protaminobacter rubrum (or similar strains like 574.77), achieving a yield of about 80% isomaltulose on a basis after purification and crystallization. The process ensures high purity (≥98% isomaltulose, with ≤2% other saccharides, ≤6% water, and minimal impurities like ≤0.1 ppm lead), making it suitable for applications. This method highlights its stability under acidic and thermal conditions, greater than that of , which reduces non-enzymatic browning and supports its use in processed s. Isomaltulose serves as a functional nutritive sweetener in a wide range of products, including beverages, baked goods, cereals, confectionery, and sports nutrition formulations, typically replacing sucrose at equivalent levels (up to 99% in some applications) and providing 17 kJ/g of energy. Its low cariogenicity stems from resistance to fermentation by oral bacteria, positioning it as a tooth-friendly alternative to sucrose. In terms of health benefits, clinical trials demonstrate that it reduces postprandial blood glucose and insulin responses by 20–52% and 30–50%, respectively, compared to high-glycemic-index carbohydrates like sucrose or maltodextrin, making it suitable for managing diabetes and supporting stable energy levels during exercise. Additional effects include enhanced fat oxidation during physical activity and improved cognitive performance, such as better memory and attention in children and adults. Safety assessments confirm isomaltulose is well-tolerated, with no adverse effects observed in human studies at intakes up to 50 g/day or 1 g/kg body weight, and a no-observed-adverse-effect level (NOAEL) of 4.5–15 g/kg body weight/day in rodent toxicity studies. It is not genotoxic and poses no risk to the general population, though caution is advised for individuals with sucrase-isomaltase deficiency or hereditary fructose intolerance. Regulatory approvals include Generally Recognized as Safe (GRAS) status by the U.S. FDA since 2006, authorization as a novel food in the European Union since 2005, approval in Japan since 1985 for specific health uses, and permission in Australia and New Zealand.

Chemical structure and properties

Molecular structure

Isomaltulose is a composed of a and a moiety, with the C<sub>12</sub>H<sub>22</sub>O<sub>11</sub> and a of 342.297 g/. Its systematic IUPAC name is 6-O-α-D-glucopyranosyl-D-fructofuranose. The features an α-1,6-glycosidic connecting the anomeric carbon (C1) of the α-D-glucopyranosyl unit to the C6 hydroxyl group of the D- unit, distinguishing it as a of , which instead possesses an α-1,2-glycosidic linkage between the anomeric carbons of both monosaccharides. This configuration positions isomaltulose within the family of reducing disaccharides. The trade name for isomaltulose is Palatinose, reflecting its commercial application as a . As a , isomaltulose exhibits chemical reactivity characteristic of its free anomeric carbon on the glucose moiety, enabling it to participate in reactions such as the or reduction of metal ions under alkaline conditions. This property arises from the structural arrangement where the glycosidic linkage does not involve both anomeric centers, unlike in non-reducing disaccharides.

Physical and chemical properties

Isomaltulose appears as a crystalline powder with a faint , resembling in its physical form. It exhibits high in , forming a 29% w/w at 20°C, equivalent to approximately 41 g per 100 g of , though this is lower than and increases with temperature to about 85% of 's at 80°C. Solubility in is notably lower, limiting its dissolution in alcoholic media. The sweetness of isomaltulose is approximately 45-50% that of on a weight basis, delivering a clean, -like without aftertaste, which rises slightly with increasing concentration in . Isomaltulose demonstrates excellent stability, melting at 123-124°C and remaining heat-stable during typical up to around 150°C without significant . It is highly resistant to acid compared to —for instance, a 20% at 2.0 remains stable for over 60 minutes at 100°C, while fully inverts under the same conditions—and maintains integrity across a range of 2.5 to 7. As a fully metabolizable , isomaltulose provides an energy content of 4 kcal/g (17 kJ/g), equivalent to other digestible carbohydrates like . Isomaltulose is characterized by low hygroscopicity, absorbing virtually no moisture at relative humidities up to 85% at 25°C, which contributes to its excellent flow properties as a free-flowing suitable for industrial handling and instant product formulations.

Sources and production

Natural occurrence

Isomaltulose, a of , was first observed in 1952 during experiments on synthesis from using the bacterium , and it was subsequently named palatinose in 1957 by researchers investigating bacterial metabolism. This discovery occurred in the context of processing studies, where microbial enzymes were found to rearrange the glycosidic linkage in from α-1,2 to α-1,6. Isomaltulose occurs naturally in small amounts in and extracts. In , concentrations typically range from 0.1% to 0.7%, though higher levels up to 3.1% have been reported in specific samples from bee colonies foraging on certain like and red . Similarly, it is present at low levels in and extracts, as well as in beet products, but these natural quantities are insufficient for commercial extraction. Trace amounts can also be found in products derived from , such as , and in certain fermented beverages produced from these sources. The natural presence of isomaltulose arises primarily from microbial action, including enzymatic by such as Erwinia rhapontici and Enterobacter during the metabolism of in environments like fields or digestion. In , this process contributes to its accumulation in through the activity of microbial enzymes in the hive or during processing. Such biological conversions mimic the industrial enzymatic production but occur at negligible scales in nature.

Industrial production

Isomaltulose is primarily produced through enzymatic of using (also known as , EC 5.4.99.11) derived from bacteria such as Protaminobacter rubrum CBS 574.77 or Erwinia species. This method rearranges the in to form the α-1,6 linkage characteristic of isomaltulose, with the typically sourced from microbial and immobilized for industrial efficiency. The process begins with a high-concentration solution, often derived from beet sugar, which is incubated with the in a column reactor. Optimal conditions include temperatures of 45–55°C and a of 6–7 to achieve conversion yields of 70–80%, with the reaction typically completing in several hours. Following , the reaction mixture is purified through ion-exchange deionization to remove impurities, followed by concentration via and either chromatographic separation or to isolate isomaltulose crystals with purity levels exceeding 99%. The and method were discovered in the by researchers at , a company, through studies on microbial , with initial documentation in 1957. Commercialization occurred in the 1980s, led by (now via its subsidiary BENEO GmbH), enabling large-scale for food applications, starting with markets in in 1985. Product quality is assessed using (HPLC) with detection to confirm isomaltulose content and purity (≥99% on a dry basis), alongside enzymatic kits for residual glucose and quantification. Microbial contamination is monitored through standard plate counts and pathogen-specific tests to ensure compliance with standards. The process generates minimal byproducts, primarily trehalulose (up to 5% of the isomerized product), which can be separated during purification. Industrial scalability supports annual production in the range of thousands of tons, facilitated by reusable systems that maintain activity over multiple batches.

Metabolism and digestion

Enzymatic hydrolysis

Isomaltulose undergoes enzymatic in the primarily by the sucrase-isomaltase complex, a membrane-bound α-glucosidase anchored at the of enterocytes. This cleaves the α-1,6-glycosidic linkage between the glucose and moieties, releasing equimolar amounts of these monosaccharides for subsequent absorption. The rate of isomaltulose is notably slower than that of owing to the structural configuration of its α-1,6 bond, which is less accessible to the 's compared to sucrose's α-1,2 linkage; in , this rate is approximately 30% of that for sucrose. In vitro assays using membrane preparations from various species, including , rats, and pigs, confirm this reduced velocity, with glucose release from isomaltulose occurring at about 25-30% the speed of . Due to this proximal and complete breakdown in the , isomaltulose exhibits no significant in the colon, as evidenced by breath tests in humans showing negligible microbial activity. This efficient small intestinal contributes to its lower relative to .

Absorption and glycemic index

Isomaltulose is fully absorbed in the following enzymatic into its constituent glucose and monomers, which are gradually released into the , providing a sustained supply to the systemic circulation. This slower rate results in peak glucose levels occurring approximately 15–30 minutes later than with , typically at 60–90 minutes post-ingestion compared to 30–45 minutes for , with peak concentrations reduced by 20–52%. The delayed and moderated glucose appearance contributes to a more stable postprandial profile, with nearly complete digestibility exceeding 95% in humans. The (GI) of isomaltulose is 32, classifying it as a low-GI , in contrast to (GI of 65) and glucose (GI of 100). This value is determined by measuring the area under the curve () of the blood glucose response over 2 hours following ingestion of 50 g of the , relative to a glucose reference. The low GI reflects the reduced and prolonged glucose excursion, with mean postprandial levels 20–50% lower in the first compared to sucrose. The of isomaltulose is similarly low, with postprandial insulin concentrations approximately 30–50% lower than those elicited by , supporting its minimal impact on insulin demand. These responses are dose-dependent, as observed in studies using 50 g doses, and can be influenced by meal context, such as co-ingestion with other macronutrients that may further modulate absorption kinetics.

Physiological effects

Energy provision and release

Isomaltulose provides a full caloric availability of 4 kcal/g, equivalent to that of and other digestible carbohydrates, as it is completely metabolized following into and in the . Once absorbed, these monosaccharides are oxidized through standard carbohydrate pathways, including to generate pyruvate and subsequent entry into the cycle for complete energy production via . This process yields no difference in total energy output compared to other carbohydrates, contributing to normal energy-yielding metabolism in the body. The distinctive feature of isomaltulose lies in its sustained energy release, achieved through slower enzymatic by sucrase-isomaltase, which delays the delivery of glucose and into the bloodstream. This results in stable plasma glucose levels for approximately 2 to 4 hours post-ingestion, avoiding the rapid spikes and subsequent crashes associated with faster-digesting sugars. Clinical studies demonstrate that equicaloric replacement of glucose or with isomaltulose prolongs glucose maintenance; for instance, one trial showed 35% less systemic glucose appearance over 2 hours compared to , with overall postprandial glucose levels 20% to 52% lower in the initial but sustained longer thereafter. Another study confirmed lower peak glucose excursions and extended availability when isomaltulose was substituted for or in healthy . These findings underscore isomaltulose's role in providing steady carbohydrate-derived energy without altering the ultimate caloric yield.

Insulin and blood glucose response

Ingestion of isomaltulose elicits a reduced peak insulin response compared to , typically 20-40% lower, attributable to its slower rate of and subsequent glucose influx into the bloodstream. In human trials involving healthy subjects, a 50 g dose of isomaltulose resulted in peak insulin concentrations approximately 52% lower than those observed with an equivalent dose of , with maximum levels occurring at 45-60 minutes post-ingestion versus around 20 minutes for . This delayed and attenuated insulin secretion aligns glucose delivery more closely with the pancreas's capacity for insulin production and release, minimizing . The blood glucose response to isomaltulose features a flatter curve with a more gradual rise and fall compared to , reflecting its lower glycemic impact. Specifically, the area under the curve () for blood glucose is 30-50% lower following isomaltulose consumption, as demonstrated in multiple crossover trials with 50 g doses in healthy adults. For instance, one study reported a glucose of 118 min × mmol/L for isomaltulose versus 184 min × mmol/L for , representing about a 36% reduction. These dynamics contribute to sustained energy availability without the sharp fluctuations associated with rapid-digesting carbohydrates.

Fat oxidation and metabolic impacts

Isomaltulose consumption has been shown to enhance postprandial oxidation compared to , primarily due to its slower and lower insulinemic response, which reduces the inhibition of . In a randomized crossover study involving individuals, indirect measurements revealed that oxidation rates were 14% higher after ingesting isomaltulose with a mixed versus (P = 0.02). Similarly, during moderate-intensity exercise, isomaltulose ingestion increased oxidation by promoting greater reliance on substrates, as evidenced by spiroergometric assessments showing elevated beta-oxidation relative to glucose-based carbohydrates. These effects stem from stable blood glucose levels that spare and favor utilization, with post-meal oxidation elevated by 15-20% in various protocols. Beyond acute substrate shifts, isomaltulose influences broader by modulating key metabolites associated with pathways. In patients with non-alcoholic , supplementation with isomaltulose led to significant reductions in levels and increases in taurodeoxycholic acid, suggesting improved lipid homeostasis and potentially lower de novo lipogenesis through altered signaling. This aligns with observations in impaired glucose , where isomaltulose minimized the postprandial decline in fat oxidation by 22% compared to , preserving non-esterified availability. Isomaltulose also exhibits prebiotic effects that may indirectly support metabolic health via gut microbiota modulation. In rodent models, it increased the abundance of beneficial genera such as and Phascolarctobacterium while reducing pathogens like Shuttleworthia, leading to elevated short-chain fatty acid production, including propionate and butyrate. These changes enhance gut barrier function and may contribute to reduced inflammation in metabolic contexts. Over longer periods, such as 7-day interventions in healthy adults, isomaltulose better preserved insulin sensitivity (as measured by HOMA-IR and Matsuda-ISI) compared to high-glycemic alternatives, potentially mitigating metabolic risk factors. Recent research as of 2025 has demonstrated that isomaltulose enhances the secretion of gut hormones (GLP-1) and (PYY) in adults with , leading to improved , reduced blood glucose peaks, and a "second-meal effect" for better postprandial glucose control.

Health applications

Diabetes management

Isomaltulose has demonstrated potential in diabetes management by attenuating postprandial glucose excursions in individuals with . In a randomized crossover study involving adults with , ingestion of 50 g isomaltulose resulted in a 20% lower peak blood glucose concentration compared to an equivalent amount of , alongside a 55% reduction in insulin secretion. This slower glycemic response is attributed to isomaltulose's low (GI) of approximately 32, which promotes more gradual carbohydrate absorption. A 2025 meta-analysis of randomized controlled trials further confirmed that isomaltulose significantly lowers glucose levels at 60 minutes post-meal by about 8 mg/dL in diabetic populations, while also improving glycemic variability through reduced peak fluctuations, though effects were more pronounced with pure sugar loads than mixed meals. In , particularly during exercise, isomaltulose supports reduced insulin demand to maintain glycemic stability. A study in adults with showed that consuming 0.6 g/kg body mass of isomaltulose two hours before high-intensity running allowed for a reduction in rapid-acting insulin doses while improving blood glucose responses and preserving performance equivalent to dextrose. Insulin requirements were lowered by approximately 50-75% in similar protocols, minimizing risk without compromising energy provision. These findings highlight isomaltulose's role in aiding insulin adjustment for active individuals with . Clinical evidence from randomized controlled trials supports isomaltulose's contribution to lower postprandial responses in . However, a key RCT found no significant improvement in long-term glycemic control (HbA1c) after 12 weeks of replacing 50 g/day with isomaltulose in patients under free-living conditions. The authorized a in 2012 under Regulation (EU) No 432/2012, recognizing isomaltulose's role in promoting normal energy-yielding through its low-GI properties, based on evidence of sustained lower blood glucose responses. Typical dosages in these studies range from 20-50 g per day, often incorporated into meals or beverages to replace .

Sports and exercise nutrition

Isomaltulose serves as a low-glycemic-index source in , providing sustained release during prolonged physical activities lasting over 60 minutes, which helps maintain stable blood glucose levels and supports in athletes. Clinical trials have demonstrated that pre-exercise ingestion of isomaltulose leads to a gradual carbohydrate oxidation profile, reducing the rate of decline in carbohydrate-derived expenditure during exercise compared to higher-glycemic alternatives like . For instance, in a involving trained , ingestion of 75 g of isomaltulose 90 minutes before a 3-hour session at 50% maximal power output resulted in attenuated exercise-induced drops in blood glucose and improved time-trial by approximately 2.7% in the final sprint phase. This sustained provision delays the onset of by promoting more efficient utilization, with studies showing enhancements in tasks through reduced glycemic fluctuations and better preservation of stores. In protocols exceeding 60 minutes, isomaltulose consumption has been associated with stable blood glucose profiles and enhanced subjective measures of alertness during exercise, contributing to overall maintenance without the peaks and crashes seen with rapid-digesting carbohydrates. Additionally, post-exercise assessments in these trials indicate improved of power, as evidenced by higher peak and mean power outputs in subsequent Wingate tests following prolonged efforts. Isomaltulose also boosts fat oxidation rates during moderate-intensity exercise, improving metabolic flexibility and substrate utilization in athletes by shifting energy reliance toward lipids early in the session, which spares glycogen for later stages. A double-blind study with endurance-trained individuals found fat oxidation to be significantly higher (p = 0.005) during cycling after isomaltulose intake compared to maltodextrin, leading to enhanced endurance capacity. Recommendations for athletes include consuming 50-75 g of isomaltulose approximately 45-90 minutes prior to endurance activities to optimize these benefits, based on dosing protocols from multiple intervention trials.

Weight control and body composition

Isomaltulose, a low-glycemic-index , has shown potential in supporting by promoting favorable changes in during energy-restricted . In a randomized, double-blind, controlled 12-week trial, 64 and obese adults (50 completed) consuming 40 g/day of isomaltulose added to an energy-reduced experienced a mean of 3.2 kg, compared to 2.1 kg in the group, though the between-group difference was not statistically significant (p = 0.258). This greater weight reduction in the isomaltulose group was accompanied by a more pronounced decrease in fat mass (-2.5 kg vs. -1.2 kg) and a significant increase in fat-free mass, indicating support for lean mass retention while targeting fat loss. The potential for isomaltulose to enhance satiety and reduce calorie intake stems from its slower digestion, which leads to prolonged blood glucose stability and lower insulin excursions compared to sucrose. This profile may indirectly curb hunger by minimizing rapid fluctuations that trigger appetite signals. Although direct measures of subjective hunger and ad libitum energy intake in acute crossover trials showed no significant differences between isomaltulose- and sucrose-sweetened foods, the greater weight loss observed in longer-term interventions suggests possible reductions in overall energy intake over time. Furthermore, isomaltulose stimulates the secretion of satiety-promoting gut hormones, including GLP-1 and PYY, which inhibit appetite and gastric emptying; in a 2024 clinical study, a mixed meal containing isomaltulose nearly tripled PYY response in individuals with type 2 diabetes compared to sucrose, with similar enhancements in healthy controls. Mechanistically, the lower insulin response to isomaltulose facilitates mobilization by reducing inhibitory effects on , contributing to decreased storage and improved on high-carbohydrate diets. This is supported by consistent findings across clinical trials showing higher postprandial oxidation rates with isomaltulose, as indicated by a lower . In animal models, such as Zucker fatty rats fed isomaltulose for 8 weeks, visceral mass and size were significantly reduced compared to . Overall, these effects position isomaltulose as a beneficial for weight control strategies focused on sustainable improvements.

Oral health

Isomaltulose exhibits non-cariogenic properties due to its limited fermentation by oral bacteria, particularly Streptococcus mutans, the primary etiological agent of dental caries. Unlike sucrose, which is readily metabolized to produce substantial lactic acid, isomaltulose yields negligible lactic acid during S. mutans fermentation, amounting to less than 10% of that generated from sucrose. This reduced acid production prevents the lowering of plaque pH below the critical threshold of 5.7, thereby minimizing enamel demineralization and tooth decay risk. Furthermore, isomaltulose does not support the synthesis of insoluble glucans by glucosyltransferases in S. mutans, leading to reduced adhesion and plaque formation compared to . In vivo plaque pH telemetry studies demonstrate that exposure to isomaltulose maintains plaque pH levels above 5.7, with mean values around 6.19–6.38, confirming no significant demineralization occurs. Animal models, such as rats infected with S. mutans, have shown markedly lower caries incidence with isomaltulose diets, with only sulcal caries observed after extended feeding periods, in contrast to extensive bucco-lingual and proximal lesions from . These attributes have led to regulatory recognition of isomaltulose as tooth-friendly. The U.S. FDA has authorized its inclusion in non-cariogenic sweeteners eligible for dental claims, based on of insufficient by oral microorganisms.

Cognitive function

Isomaltulose, a low-glycemic-index , provides a sustained release of glucose into the bloodstream, which supports cognitive function by maintaining stable blood glucose levels and avoiding the rapid fluctuations associated with high-glycemic-index sugars like . This stability is particularly beneficial for and tasks performed 1 to 2 hours post-ingestion, as it prevents the hypoglycemic dips that can impair mental performance. In children, clinical trials have demonstrated enhanced cognitive outcomes with isomaltulose compared to or higher-glycemic-index alternatives. A double-blind involving 75 children aged 5 to 11 years found that an isomaltulose-based improved immediate and delayed performance at 3 hours post-ingestion, with no such benefits observed after a glucose-based meal, which led to a decline in memory scores. Similarly, a 2013 crossover trial with 49 Indonesian children aged 5 to 6 years using isomaltulose-enriched growing-up milk showed superior numeric and delayed accuracy versus standard milk containing higher-glycemic carbohydrates. These effects align with isomaltulose's role in providing sustained energy to the without the peaks and troughs that disrupt focus in young learners. Studies in adults and older populations further support isomaltulose's cognitive advantages, particularly in mood and alertness during low-energy states. A 2023 randomized, double-blind crossover trial with 64 healthy adults (mean age 48 years) reported that 10 grams of palatinose (isomaltulose) significantly reduced reaction times in attention tasks at 1, 2, and 3 hours post-ingestion compared to glucose, alongside increased cerebral blood flow in prefrontal areas linked to executive function. In middle-aged and older adults (aged 45 to 80 years), a 2014 randomized trial of 155 participants found that isomaltulose-based meals improved episodic and working memory, as well as mood, at 105 and 195 minutes post-consumption, with benefits most pronounced in those with good glucose tolerance versus sucrose or glucose equivalents. These mood enhancements, including reduced fatigue and greater alertness, stem from the avoidance of hyperglycemic swings that can induce mental lethargy. The mechanisms underlying these cognitive benefits involve isomaltulose's slower by intestinal enzymes, which results in a gradual glucose supply to the , mitigating hypo- and hyperglycemic episodes known to negatively affect neuronal activity and function. This contrasts with , which causes sharper glucose excursions that may overload or deplete cognitive resources over time.

Commercial uses

In food and beverage products

Isomaltulose is incorporated into various and beverage products as a functional that serves as a partial or full replacement for , offering similar technological properties while addressing demands for reduced glycemic impact in everyday consumables. In beverages, particularly sports drinks, it is commonly used at concentrations of 6-10% to provide sustained energy release without rapid osmotic effects, maintaining profiles comparable to body fluids. For items such as breads and muffins, isomaltulose can replace traditional sugars on a 1:1 basis by weight, enabling stable dough handling and consistent baking outcomes due to its heat stability. In products like chews and fondants, it prevents unwanted by forming a non-crystalline phase when blended appropriately, allowing for smoother textures and extended without altering visual appeal. Key benefits of isomaltulose in these applications include its clean, sucrose-like taste profile with no lingering aftertaste, which enhances overall sensory acceptance in formulated products. Additionally, as a , it participates effectively in the during baking and processing, promoting desirable browning and flavor development similar to , though at a potentially enhanced rate in certain mixtures. The market for isomaltulose in food and beverages is expanding, driven by its role in low-GI formulations for functional foods, with global demand projected to grow from approximately USD 1.2 billion in 2024 to USD 1.6 billion by 2030 at a CAGR of 5.4%, reflecting trends toward steady-energy products in 2025 and beyond. However, adoption faces challenges, including higher production costs than due to enzymatic conversion processes, and limited in high-sugar mixtures at ambient temperatures, which may require heating for higher concentrations.

In nutritional supplements

Isomaltulose is incorporated into various nutritional supplements designed for targeted and performance needs, particularly in forms such as powders, , and gels. These supplements typically provide 30-50 grams of isomaltulose per serving to deliver sustained energy without rapid sugar spikes, making them suitable for athletes during endurance activities and for individuals with managing glycemic control. In meal replacement products, isomaltulose is often combined with proteins like or isolates and dietary fibers such as root to enhance satiety and support while maintaining stable energy levels. For instance, protein-energy bars blend isomaltulose with grams of whey and proteins per serving to provide prolonged fuel during physical exertion. These combinations leverage isomaltulose's low to complement protein and fiber for better postprandial metabolic responses in users seeking balanced nutrition. The market for isomaltulose in nutritional supplements has seen notable growth, especially within the sports nutrition segment and support aids, driven by demand for low-glycemic functional ingredients. Estimates for the global isomaltulose market as of 2025 vary, with one projection valuing it at approximately USD 865 million and anticipating steady expansion through 2035 due to increasing adoption in performance and health-focused products. Branded isomaltulose, such as Palatinose, is prominently featured in gels like Amix Performance Slow Palatinose Gel and Energy Gel, which combine it with other carbohydrates for sustained release during exercise. This sustained energy provision aligns with benefits, supporting fat oxidation and endurance without performance dips.

Safety and regulation

Toxicology and safety data

Isomaltulose exhibits a favorable profile in studies, with low and no adverse effects observed at high doses in rats. Similarly, subacute administration in rats at doses equivalent to 1.7–8.1 g/kg body weight per day for 13 weeks resulted in no signs of , including normal clinical observations, body weight gain, and organ . In chronic toxicity evaluations, isomaltulose showed no evidence of in standard assays, such as the , and no mutagenic potential. No carcinogenicity studies specific to isomaltulose have been conducted, but long-term feeding trials in rats up to 26 weeks at doses of 4.5 g/kg body weight per day revealed no treatment-related neoplastic or non-neoplastic effects. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has not established a numerical (ADI) for isomaltulose, classifying it as safe for use analogous to other digestible sugars without specified limits. Human studies demonstrate good tolerance of isomaltulose at daily intakes up to 50 g, with no significant adverse effects reported in healthy adults or children across multiple clinical trials. Mild gastrointestinal effects, such as bloating or loose stools, may occur osmotically at higher doses exceeding 100 g per day, but these are comparable to those from equivalent intake and resolve quickly. In 2024, the (EFSA) evaluated isomaltulose syrup (dried) as a and concluded it is as safe as based on comprehensive literature review, including toxicological data from animal and human studies.

Regulatory approvals

Isomaltulose received its initial regulatory approval as a food additive in Japan in 1985, marking the first country to authorize its use in food products. In the European Union, it was approved as a novel food ingredient under Commission Decision 2005/457/EC, permitting its placement on the market for use in foodstuffs. In June 2024, the European Commission authorized isomaltulose syrup (dried) as a novel food under Regulation (EU) 2024/1611. The United States Food and Drug Administration issued a letter of no objection for its generally recognized as safe (GRAS) status in 2006 via GRAS Notice No. 184, allowing its use as a nutritive sweetener in various food categories and beverages. Food Standards Australia New Zealand granted novel food approval in 2007 through Application A578, enabling its incorporation into general foods. Regarding health claims, the has approved assertions related to the non-cariogenic properties of isomaltulose, recognizing its low potential to contribute to dental caries based on its minimal acid production in the oral environment. However, no specific authorized claim exists in the for reduction of postprandial glycaemic responses, despite supporting from human intervention studies demonstrating lower blood glucose peaks compared to . Safety assessments underpinning these approvals confirm its tolerability at typical intake levels. As of 2025, regulatory frameworks in have seen expanded applications for isomaltulose in functional foods, driven by growing demand for low-glycaemic sweeteners in health-oriented products across markets like , , and . The global market for isomaltulose is forecasted to reach USD 2,189.56 million by 2035, reflecting a of 5.4% from 2025 onward, fueled by approvals and consumer trends toward sugar alternatives. Labeling requirements specify isomaltulose or its Palatinose™ on product , with no quantity-based restrictions in most approved regions; it is treated as a but qualifies for exclusion from "added sugars" declarations in the pending final guidance, due to its distinct metabolic profile.

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