Safety evaluation of highly-branched cyclic dextrin and a 1,4-α-glucan branching enzyme from Bacillus stearothermophilus
Abstract
Highly-branched cyclic dextrin (HBCD), a dextrin food ingredient presently only used in Japan, was investigated for digestibility and potential toxicity. HBCD was readily hydrolyzed in vitro to maltose and maltotriose by human salivary and porcine pancreatic alpha-amylases. Incubation of HBCD with a rat intestinal homogenate, containing digestive enzymes, resulted in the formation of maltose, maltotriose, and maltotetraose, and with longer incubation times, resulted in the formation of glucose. In an acute toxicity study, Wistar rats orally administered a single-dose of 2000mg/kg body weight of HBCD did not display mortality or any signs or symptoms of toxicity or abnormalities upon necropsy. Transient loose stools were observed, but were resolved within 24h of HBCD administration, and therefore, were not considered as compound-specific adverse effects. In the Ames assay, HBCD was non-mutagenic with or without metabolic activation. Toxicity testing of the branching enzyme (BE) involved in the synthesis of HBCD showed that the BE also was not acutely toxic when orally administered to rats and was non-mutagenic in the mouse lymphoma assay. The results of this study demonstrate that HBCD is digested to normal and safe products of carbohydrate digestion, and therefore, support the safety of HBCD for human consumption.
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HBCD is produced from waxy corn starch using bacterial-derived α-amylase and α-(1→4)-glucan-branching enzyme, with validated results regarding safety for human consumption.
“HBCD is produced from the processing of waxy corn starch using bacterial-derived α-amylase and α-(1→4)-glucan-branching enzyme (EC 2.4.1.18), a member of the broader group of glucanotransferases with validated results regarding the safety for human consumption [77].”
From The 4R’s Framework of Nutritional Strategies for Post-Exercise Recovery: A Review with Emphasis on New Generation of Carbohydrates (2020) · cites this paper as [77]
Cyclodextrins have glycosidic bonds that salivary amylases can hydrolyze slowly due to thermodynamic parameters, and therefore have very low glycemic indexes and provide a longer time of glucose supply to the bloodstream.
“Cyclodextrins have glycosidic bonds that salivary amylases are able to hydrolyze but they act slowly due to thermodynamic parameters [76]; therefore, cyclodextrins have very low glycemic indexes and provide a longer time of glucose supply to the bloodstream [77,78].”
From The 4R’s Framework of Nutritional Strategies for Post-Exercise Recovery: A Review with Emphasis on New Generation of Carbohydrates (2020) · cites this paper as [77]
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Bonilla, D. A., Pérez-Idárraga, A., Odriozola-Martínez, A., & Kreider, R. B. (2020) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph18010103 · Cited by 77 · see citing works
“18), a member of the broader group of glucanotransferases with validated results regarding the safety for human consumption [77].”
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Self-citation
- Authors
- Choi, S. S. H., Danielewska-Nikiel, B., Ohdan, K., Kojima, I., Takata, H., & Kuriki, T.
- Affiliations
- Cantox Health Sciences International (CA)
- Ezaki Glico (Japan) (JP)
- Corresponding author
- Choi, Sharon S.H.
- Venue
- Regulatory Toxicology and Pharmacology
- Publisher
- Elsevier BV
- Published
- 2009-12
- Volume
- 55
- Issue
- 3
- Pages
- 281-290
- ISSN
- 0273-2300 (ISSN-L)
- OpenAlex
- W1982487514
- Cited by
- 22
- References
- 42
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 1 · 2023: 4 · 2022: 2 · 2021: 1 · 2020: 3 · 2018: 1 · 2017: 3 · 2015: 1
- FWCI
- 0.53
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Regulatory Toxicology and Pharmacology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Carcinogens and Genotoxicity Assessment
- Physical Sciences › Chemistry › Analytical Chemistry › Dye analysis and toxicity
- Keywords
- Bacillus stearothermophilus, food additive safety, digestibility, alpha-amylase hydrolysis, maltotriose, maltose, acute toxicity, mutagenicity, intestinal digestion
- MeSH terms
- Administration, Oral, alpha-Amylases, Animals, Geobacillus stearothermophilus, Dextrins, Digestion, Female, Food Additives, Humans, Japan, Lymphoma, Male, Mutagenicity Tests, Pancreas, Saliva, Swine, 1,4-alpha-Glucan Branching Enzyme, Rats, Wistar, Toxicity Tests, Acute, Cell Line, Tumor, Mice, Rats
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