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Polyglycitol

Table of contents

Other Names

E 964HSHHydrogenated glucose syrupHydrogenated starch hydrolysateHydrogenated starch hydrolysatesHydrogenated starch hydrolyzateINS 964Maltitol syrupPolyglucitolPolyglucitol syrupPolyglycitol syrupSorbitol syrupSyrups, hydrolyzed starch, hydrogenated

Synopsis

Polyglycitol (Hydrogenated Starch Hydrolysate Syrup)

Identity and Chemical Characterization

Polyglycitol, most precisely described as polyglycitol syrup, is the internationally recognized common name for a class of ingredients also known as hydrogenated starch hydrolysates (HSH). Hydrogenated starch hydrolysates (HSHs), also known as polyglycitol syrup, carry the International Numbering System (INS) designation INS 964 and are mixtures of several sugar alcohols (a type of sugar substitute). In the European Union the substance is assigned food additive code E 964. The approved low-calorie sweeteners in the EU include, among others, polyglycitol syrup (E-964), alongside sorbitol and sorbitol syrup (E-420), mannitol (E-421), isomalt (E-953), maltitol and maltitol syrup (E-965), lactitol (E-966), xylitol (E-967), and erythritol (E-968).

Polyglycitol syrup is a manufactured sugar substitute derived from the hydrogenation of starch hydrolysates, primarily composed of maltitol, sorbitol, and higher molecular weight polyols. Polyglycitol syrup consists mainly of maltitol and sorbitol, and to a lesser extent hydrogenated oligo- and polysaccharides and maltotriitol. More precisely, polyglycitols contain less than 50% maltitol and less than 20% sorbitol on a dry basis.

The CAS number for the representative molecular formula is 68425-17-2, with a molecular formula of C18H34O16 and a molecular weight of 506.45 g/mol. The key chemical names within the mixture are sorbitol (D-glucitol; C6H14O6; MW 182.2) and maltitol ((Ξ±)-D-glucopyranosyl-1,4-D-glucitol; C12H24O11; MW 344.3).

The name polyglycitol or HSH is used when there is no dominant polyol such as maltitol or sorbitol in the mixture. This distinguishes polyglycitol syrup from maltitol syrup, which by definition contains at least 50% maltitol. In contrast to maltitol syrup EU specifications, polyglycitol syrup has a defined concentration of sorbitol, a lower concentration of maltitol, and a defined concentration of higher molecular weight polyols; consequently, it is not covered by the specifications for maltitol syrup, which is an EU-authorized food additive.

Physical Properties and Common Forms

Polyglycitol syrup is a colorless and odorless clear viscous liquid, very soluble in water and slightly soluble in ethanol. It has no cooling effect, in contrast to some other polyols such as xylitol and erythritol. HSH sweeteners provide 40 to 90% sweetness relative to table sugar (sucrose).

Polyglycitol is primarily encountered as a liquid syrup and is used as such in food manufacturing. Its functional roles span multiple categories: purposes for polyglycitol syrup include use as a bulking agent, humectant, stabilizing agent, and sweetening agent. Additional functional uses documented for food additives in this category include texturizers and stabilizers.

Natural Source and Manufacturing Origin

Polyglycitol syrup is not a naturally occurring substance in the strict sense. It is not naturally occurring but is synthesized for use as a low-calorie sweetener in various food products. Its raw material substrates, however, are plant-derived. Hydrogenated starch hydrolysates are produced by the partial hydrolysis of starch β€” most often corn starch, but also potato starch or wheat starch. These starch hydrolysates may be derived from carbohydrate sources such as corn, wheat, or barley.

Polyglycitol syrup is produced by catalytic hydrogenation of a mixture of starch hydrolysates composed of glucose, maltose and higher glucose polymers, similar to the catalytic hydrogenation process used in maltitol syrup production. The resulting syrup is desalted by ion exchange and concentrated to the desired level.

Regarding the history of its development as an industrial product: hydrogenated starch hydrolysates were developed by the Swedish company Lyckeby Starch in the 1960s. Polyglycitol is classified among the polyols β€” sugar alcohols formed via the catalytic hydrogenation of carbohydrates, in this case produced from starch hydrolysate. Polyols are a specific group of sugar alcohols formed via the catalytic hydrogenation of carbohydrates. They are found naturally in certain fruits, vegetables, and mushrooms; however, they are also commonly used as sugar-free sweeteners in products such as chewing gum, candies, and beverages.

Traditional and Historical Use

Polyglycitol syrup, as a specific manufactured substance, does not have a documented history of traditional or pre-industrial use. Polyglycitol syrup, often referred to as polyglycitol syrup or hydrogenated starch hydrolysates, has a relatively modern origin compared to traditional herbal remedies, but its core components β€” sugar alcohols β€” have been studied and utilized in various medicinal and nutritional contexts.

The broader class of sugar alcohols that compose polyglycitol does carry some historical context. Historically, sugar alcohols have been used as gentle laxatives and digestive aids, offering an alternative for those seeking relief from constipation or digestive discomfort. In the early to mid-20th century, these compounds began to appear more frequently in medicinal syrups and lozenges, addressing both palatability and therapeutic needs.

Developed as a low-calorie sweetener, polyglycitol syrup is valued for its ability to provide sweetness and texture without contributing to the rapid spike in blood sugar associated with traditional sugars. Over the latter decades of the 20th century, following its development in the 1960s, it found growing application in sugar-free confectionery products. Its non-cariogenic nature means it does not promote tooth decay, making it a choice for herbal cough drops, throat lozenges, and syrups that blend botanicals such as licorice root, echinacea, and slippery elm.

Key Constituents and Composition

The composition of polyglycitol syrup is defined by its mixture of sugar alcohols arising from the hydrogenation of starch-derived saccharides. The major constituents are:

  • Maltitol β€” the hydrogenation product of maltose; present at less than 50% (dry basis); a disaccharide polyol.
  • Sorbitol β€” the hydrogenation product of glucose; present at less than 20% (dry basis).
  • Maltotriitol β€” the hydrogenation product of maltotriose.
  • Higher-order hydrogenated oligo- and polysaccharides β€” arising from the hydrogenation of longer glucose chains in the starch hydrolysate.

HSH contains some sorbitol (from glucose), maltitol (from maltose), maltotriitol (from maltotriose), and so on. The precise ratio of these components can vary with the source starch and the conditions of hydrolysis and hydrogenation, and different commercial grades of polyglycitol syrup exist. For example, one commercial formulation described in specifications is a "14:8:78" mixture (sorbitol:maltitol:higher polyols) while another is a "7:60:33" mixture, although the latter would more precisely be classified as a high-maltitol polyglycitol variant.

Quality specifications require not less than 99% total hydrogenated saccharides on an anhydrous basis, not less than 50% of polyols of higher molecular weight, not more than 50% maltitol on the anhydrous basis, and not more than 20% sorbitol.

Mechanisms of Action

Gastrointestinal Absorption and Metabolism

The physiological properties of polyglycitol syrup derive from the incomplete and slow absorption of its constituent polyols in the small intestine. HSH are slowly absorbed in the digestive tract. A portion of HSH may be enzymatically hydrolyzed in the body to sorbitol, maltitol and glucose; however, this process is slow. Therefore, HSH have a reduced glycemic potential relative to glucose for individuals with and without diabetes.

Since HSH are more slowly absorbed, a portion of HSH in a food reaches the lower digestive tract where it is metabolized by naturally occurring colonic bacteria. This results in a reduction in the available calories and permits its use as a reduced calorie alternative to sugar.

The incomplete absorption mechanism is confirmed by breath hydrogen measurement. Breath H2 levels were unaffected by glucose challenge but were increased by the hydrogenated starch hydrolysate syrups, as a result of fermentation of unhydrolyzed, unabsorbed material by the gut flora. These results were taken to indicate that the glycemic response to hydrogenated starch hydrolysate syrups is lower than that to glucose in both diabetic and non-diabetic individuals. In addition to the lower content of glucose in the hydrogenated starch hydrolysate syrups, an inhibitory effect of sorbitol on glucose uptake was considered to affect the glycemic response.

Colonic Fermentation and Short-Chain Fatty Acid Production

The fermentation process of unabsorbed polyglycitol components in the colon produces short-chain fatty acids and gases. The low glycemic response is attributed to this slow and incomplete absorption. Fermentation in the colon can also modulate gut microbiota composition, potentially leading to prebiotic effects. However, it should be noted that no clinical studies specifically demonstrating confirmed prebiotic benefits of polyglycitol syrup itself (as distinct from its components) were identified in the authoritative literature reviewed.

Non-Cariogenic Mechanism

Hydrogenated starch hydrolysates are non-cariogenic because they are only slightly (or not at all) fermented by cariogenic oral microorganisms and inhibit sucrose utilization by Streptococcus mutans. Polyols, including HSH, are resistant to metabolism by oral bacteria that break down sugars and starches to release acids that may lead to cavities or erode tooth enamel. They are, therefore, non-cariogenic and safe for teeth.

Caloric Contribution

Polyglycitol syrups contain about 3 kilocalories per gram, compared to approximately 4 kcal/g for sucrose and other digestible carbohydrates. This reduced caloric density results from the partial malabsorption and partial fermentation of the polyol mixture.

Scientific Evidence by Area of Use

1. Glycemic Response and Blood Glucose Management

The most robustly documented area of evidence for polyglycitol syrup concerns its low glycemic and insulinemic indices relative to sucrose. Analysis of the literature on glycemia and insulinemia after polyol ingestion yielded a glycemic index (GI) value of 39 and an insulinemic index (II) of 23 for polyglycitol syrup. These values are all substantially lower than sucrose (GI 65, II 43) or glucose (GI 100, II 100).

This evidence comes from Livesey's comprehensive review (2003) in Nutrition Research Reviews, which analyzed the pooled human data on glycemia and insulinemia from studies of various polyols including polyglycitol, and covered normal, type 2 diabetes, and type 1 diabetes subjects. Direct randomized controlled trials specifically on polyglycitol syrup are limited, with much of the evidence extrapolated from its constituent polyols.

The JECFA (WHO/FAO) evaluation of polyglycitol syrup, conducted at the 51st meeting of the Joint Expert Committee on Food Additives (1998/1999), incorporated direct human studies. In studies of diabetic and non-diabetic human subjects, ingestion of polyglycitol and maltitol syrups resulted in a lower glycemic response than with glucose, in the order: maltitol syrup < polyglycitol syrup < glucose. These results reflect the relative proportion of glucose released by hydrolysis of each material.

Evidence strength assessment: The glycemic index data are considered well-established, drawn from multiple human studies including diabetic subjects; however, these are primarily short-term metabolic challenge studies (bolus-dose, postprandial glucose response designs) rather than long-term randomized controlled trials (RCTs) examining clinical outcomes such as HbA1c or cardiovascular risk. Several regulatory assessments and systematic reviews on polyols exist, but direct randomized controlled trials specifically on polyglycitol syrup are limited.

2. Dental Health (Non-Cariogenicity)

The non-cariogenic property of hydrogenated starch hydrolysates, including polyglycitol, is among the most thoroughly documented characteristics. Similar to xylitol, hydrogenated starch hydrolysates are not readily fermented by oral bacteria and are used to formulate sugarless products that do not promote dental caries. HSHs are also more slowly absorbed in the digestive tract, thus have a reduced glycemic potential relative to glucose.

Polyols, including HSH, are resistant to metabolism by oral bacteria that break down sugars and starches to release acids that may lead to cavities or erode tooth enamel; they are therefore non-cariogenic. The usefulness of polyols as alternatives to sugars and as part of a comprehensive program including proper dental hygiene has been recognized by the American Dental Association.

Evidence strength assessment: The non-cariogenic designation is well-supported by in vitro microbiological evidence and clinical observations, consistent across polyols as a class, and underpins regulatory and dental authority endorsements.

3. Weight Management and Caloric Reduction

Polyols represent attractive alternatives to sucrose because they provide fewer calories per gram, do not promote tooth decay, and are not associated with an elevated blood glucose response. The US FDA has approved the use of 8 different polyols, which include erythritol, hydrogenated starch hydrolysates, isomalt, lactitol, maltitol, mannitol, sorbitol, and xylitol.

At approximately 3 kcal/g, polyglycitol syrup delivers fewer calories than sucrose when used as a direct substitute. No long-term RCTs specifically evaluating polyglycitol syrup's role in body weight management have been identified in the peer-reviewed literature reviewed here. The caloric reduction benefit, while mechanistically logical, remains inferred from its reduced caloric density and glycemic profile rather than directly demonstrated through weight-outcome clinical trials specific to polyglycitol.

Evidence strength assessment: Mechanistically plausible and supported by caloric and glycemic data; direct human clinical trial evidence specifically for polyglycitol syrup on weight outcomes is lacking.

4. Digestive/Gastrointestinal Effects

Polyglycitol syrup's behavior in the lower gastrointestinal tract β€” partial fermentation by colonic bacteria β€” is a double-edged property. At moderate doses it represents a physiological mechanism for calorie reduction; at higher doses it can produce adverse gastrointestinal effects (see Safety section). Polyols can induce dose-dependent gastrointestinal symptoms of flatulence, bloating, abdominal discomfort, and laxative effects when consumed in healthy volunteers and patients with irritable bowel syndrome (IBS). However, there is a substantial degree of intra- and inter-subject variability in symptoms, and patients with IBS tend to report symptoms after consumption of lower doses of polyols than healthy volunteers do.

Although malabsorption likely accounts for a portion of symptoms, other factors, including the type of polyol ingested, the consumption pattern, and the colon's ability to reabsorb water, are also likely involved in inducing gastrointestinal symptoms. A relevant limitation to the review of this topic is the lack of studies evaluating polyols in isolation rather than in combination with other carbohydrates. Therefore, the individual effect of polyols on factors such as absorption, gastrointestinal motility, and visceral sensation is difficult to determine with confidence.

5. Use in Diabetic Populations

Control of blood glucose, lipids, and weight are the three major goals in diabetes management. HSH absorption is slow and incomplete. HSHs have a low glycemic index and do not significantly increase blood glucose and insulin levels. Key characteristics of polyglycitol syrup include its sweetening properties with reduced caloric content and a low glycemic index (GI ~39) and insulinemic index (~23) compared to sucrose, making it potentially beneficial for individuals managing diabetes or weight.

The JECFA monograph specifically noted human studies in diabetic subjects. Results were taken to indicate that the glycemic response to hydrogenated starch hydrolysate syrups is lower than that to glucose in both diabetic and non-diabetic individuals.

Evidence strength assessment: Short-term postprandial glycemic response data from human subjects, including those with diabetes, demonstrate attenuated blood glucose and insulin responses relative to glucose and sucrose. Long-term trials examining clinical endpoints in diabetic patients (e.g., HbA1c, complication rates) specific to polyglycitol syrup have not been identified in the reviewed authoritative literature.

Body Systems and Health Areas

  • Metabolic/Endocrine system: Attenuated postprandial blood glucose and insulin responses; reduced glycemic and insulinemic indices versus sucrose and glucose.
  • Gastrointestinal system: Partial fermentation by colonic microbiota producing short-chain fatty acids; potential prebiotic-type effects (unconfirmed in specific polyglycitol clinical trials); dose-dependent laxative and flatulence effects from osmotic and fermentation mechanisms.
  • Oral/Dental health: Non-cariogenic; resistant to metabolism by cariogenic oral bacteria; does not promote dental caries.
  • Energy metabolism: Reduced caloric density (~3 kcal/g) relative to sucrose; partial malabsorption contributes to lower net caloric availability.

Dosage Forms and Reported Dosages

Polyglycitol syrup is exclusively available and used as a liquid syrup. It does not exist in commercially distributed capsule, tablet, or powder supplement form independent of food matrices in the peer-reviewed literature reviewed. It is incorporated into food products and serves as an excipient or vehicle in pharmaceutical syrups and confectionery.

Regarding specific doses studied or reported in the authoritative literature:

  • If consumed in amounts greater than 125 grams per day, HSHs can trigger diarrhea.
  • In the JECFA animal toxicity studies, the food consumption of the four groups receiving 20% liquid carbohydrate material was slightly increased in comparison with the control groups. The intakes of each of the substances in treated diets were as follows for males and females: 4.2/4.9, 8.3/9.9, and 13/15 g/kg body weight per day of the 6.7%, 13%, and 20% 14:8:78 mixtures, respectively.
  • The EFSA Panel, in assessing exposure from proposed food additive uses, considered chronic intakes averaged over 7-day periods as the relevant timeframe for evaluating digestive tolerance effects.

No specific human therapeutic dosage has been established or is recognized in regulatory monographs. There is no established minimum effective dose for therapeutic effects, as polyglycitol syrup is primarily used as a sweetener.

Regulatory Status

In the EU, polyglycitol syrup has been recognized with food additive number E 964 since 2012. Polyglycitol is approved for use in a number of food categories in the European Union.

The HSH family of polyols is an approved food ingredient in Canada, Japan, and Australia.

The JECFA evaluation of polyglycitol syrup was conducted at the 51st meeting of the Joint FAO/WHO Expert Committee on Food Additives (1998–1999), and was published in WHO Food Additives Series 42 (1999). Polyglycitol syrup had not previously been evaluated by the JECFA Committee prior to that meeting. Since its components are the same as those of maltitol syrup, differing only in the relative proportions of sorbitol, maltitol, and higher-order polyols, the evaluation conducted for maltitol syrup was considered directly applicable.

On the basis of the data on hydrogenated oligo- and polysaccharides reviewed at the forty-ninth and the fifty-first JECFA meetings, the Committee allocated a group ADI "not specified." An "ADI not specified" is the most favorable designation JECFA issues, indicating no numerical Acceptable Daily Intake was required given the safety data available.

The EFSA's 2009 scientific opinion concluded that the toxicological data available on polyglycitol syrup are insufficient to establish a numerical Acceptable Daily Intake (ADI), but that there is no indication of a safety concern for the proposed uses of polyglycitol syrup.

In Canada, polyglycitol syrup is categorized as a non-natural health product because it is not a naturally occurring substance included in Schedule 1 of the Natural Health Products Regulations.

Safety Considerations and Known Adverse Effects

Gastrointestinal Disturbance

In humans, the main reported adverse effect specifically associated with polyglycitol syrup exposure is gastric disturbance. In its assessment, the EFSA stated that exposure to polyglycitol syrup in the average diet is high enough to be close to dosage levels associated with gastric disturbances. The EFSA stated that laxative effects should therefore be taken into account as with other polyols authorized as food additives.

The EFSA Panel considered that conservative estimates of the exposure to polyglycitol syrup, for consumer-only and the general population, arising from the proposed uses and use levels, are close to, and for children even higher than, doses associated with gastric disturbances when administered as bolus doses in human trials and as reported in recent case reports.

Children may be more susceptible to gastrointestinal disturbances at lower doses compared to adults, warranting conservative intake in this population.

Dose-Dependent Laxative Effect

Polyols can induce dose-dependent gastrointestinal symptoms of flatulence, bloating, abdominal discomfort, and laxative effects when consumed in healthy volunteers and patients with IBS. The laxative mechanism operates through two pathways: osmotic effects from unabsorbed polyol drawing water into the colon, and bacterial fermentation producing gas. The degree of absorption is dose-dependent, and malabsorption can lead to gastrointestinal symptoms.

IBS and Sensitive Populations

There is a substantial degree of intra- and inter-subject variability in gastrointestinal symptoms from polyol ingestion, and patients with IBS tend to report symptoms after consumption of lower doses of polyols than healthy volunteers do. Polyols as a class are recognized as fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs), a dietary group implicated in IBS symptom triggers, though specific clinical trial evidence for polyglycitol syrup in IBS patients was not identified in the authoritative sources reviewed.

Urinary Calcium

In a 13-week dietary rat toxicity study reviewed by JECFA, the only effects observed β€” increased weight of the empty cecum and increased urinary calcium excretion in the absence of elevated serum calcium β€” were considered to be the consequence of the accumulation of poorly absorbed material in the cecum and were deemed to be of no toxicological significance. No effect of treatment was evident from hematological and clinical chemical examinations, including values for serum calcium ion. Statistically significantly increased total calcium excretion, urinary calcium concentration, and urinary calcium:creatinine ratio over the values in both control groups were noted in both males and females. This was not considered adverse at the levels observed.

Carcinogenicity

There is no evidence for a cancer-promoting effect (carcinogenicity) of maltitol syrup (polyglycitol).

Animal Reproductive Findings

Although a number of effects were observed in animal studies, including a decrease in the average testis-to-body weight ratio of male rats, the EFSA considered these consequences to be "non-adverse."

Summary of Safety Profile

The overall regulatory consensus from JECFA, EFSA, and national health agencies is that polyglycitol syrup presents no indication of a safety concern at the levels used in food products, with gastrointestinal tolerance (particularly in children and IBS patients) representing the principal practical limitation. HSHs do not seem to have any serious side effects. The European Food Safety Authority Panel on Food Additives and Nutrient Sources added to Food concluded there are no safety concerns when using appropriate levels of the syrup.

References

Health Conditions

Health conditions that Polyglycitol may help support.

  • No conditions available.

Body Systems

Body systems that Polyglycitol may help support.

  • No body systems available.
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