Efficacy of a novel supplement GlucoSEB PB™ for glucose management: an in vitro and clinical study approach
DOI:
https://doi.org/10.18203/2349-3259.ijct20260044Keywords:
GlucoSEB PB™;, INFOGEST semi-dynamic digestion, Sugar profile, Prediabetes, Postprandial blood glucose levelsAbstract
Background: The objective of the study was to perform a comprehensive investigation of GlucoSEB PB™ using in-vitro digestion and a clinical study for evaluating its effects on sugar digestion and associated metabolic responses.
Methods: In-vitro digestion of a bread-chicken-patty as a food-matrix was performed using INFOGEST simulated semi-dynamic digestion protocol in presence and absence of GlucoSEB PB™. The sugars released were quantified. Further, for the clinical trial, a double-blind, randomized, crossover, placebo-controlled study was performed by randomizing 35-prediabetic subjects into test and placebo groups. Subjects were instructed to consume 2-capsules (test or placebo), 30-min prior to consumption of standard-meal, and blood-glucose related parameters were monitored.
Results: GlucoSEB PB™ effectively caused a net reduction in the available simple-sugars by 19.40% post in-vitro gastro-intestinal digestion. This was due to formation of oligosaccharides with dietary-fiber potential conferring prebiotic benefits. The findings of the clinical-study indicated an increase in blood-glucose levels until 45 and 60-min in the GlucoSEB PB™ and placebo groups, followed by a continuous decline for 3-h post-consumption of the standard-meal. GlucoSEB PB™ supplementation resulted in a 16.90% reduction in AUC over the placebo, signifying its role in controlling blood-glucose. Additionally, no variations were observed in insulin levels in both arms.
Conclusion: Notably, GlucoSEB PB™ was safe and showcased tolerability at the investigated dosage. No AEs/SAEs were reported during the entire investigation.
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References
Danaei G, Finucane MM, Lu Y, Singh GM, Cowan MJ, Paciorek CJ, et al. National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2·7 million participants. Lancet. 2011;378(9785):31-40. DOI: https://doi.org/10.1016/S0140-6736(11)60679-X
Mathew TK, Zubair M, Tadi P. Blood Glucose Monitoring. In: StatPearls. Treasure Island (FL): StatPearls Publishing. 2025. Available at: https://www.ncbi.nlm.nih.gov/books/NBK555976. Accessed on 20 October 2025.
Schlesinger S, Neuenschwander M, Barbaresko J, Lang A, Maalmi H, Rathmann W, et al. Prediabetes and risk of mortality, diabetes-related complications and comorbidities: umbrella review of meta-analyses of prospective studies. Diabetologia. 2022;65:275-85. DOI: https://doi.org/10.1007/s00125-021-05592-3
Mahat RK, Singh N, Arora M, Rathore V. Health risks and interventions in prediabetes: A review. Diabetes Metab Synd. Clin Res Rev. 2019;13(4):2803-11. DOI: https://doi.org/10.1016/j.dsx.2019.07.041
International Diabetes Federation. Diabetes Atlas, 10th edition. 2021. Available at: https://www. diabetesatlas.org. Accessed on 20 October 2025.
Blond MB, Færch K, Herder C, Ziegler D, Stehouwer CD. The prediabetes conundrum: striking the balance between risk and resources. Diabetologia. 2023;66:1016-23. DOI: https://doi.org/10.1007/s00125-023-05890-y
Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, et al. Management of hyperglycemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022;45(11):2753-86. DOI: https://doi.org/10.2337/dci22-0034
Aloke C, Egwu CO, Aja PM, Obasi NA, Chukwu J, Akumadu BO, et al. Current advances in the management of diabetes mellitus. Biomedicines. 2022;10:2436. DOI: https://doi.org/10.3390/biomedicines10102436
Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, et al. Exercise and type 2 diabetes: The American college of sports medicine and the American diabetes association: joint position statement. Diabetes Care. 2010;33(12):e147-67. DOI: https://doi.org/10.2337/dc10-9990
Tiwari P. Recent trends in therapeutic approaches for diabetes management: a comprehensive update. J Diabetes Res. 2015;2015:340838 DOI: https://doi.org/10.1155/2015/340838
Forouhi NG, Misra A, Mohan V, Taylor R, Yancy W. Dietary and nutritional approaches for prevention and management of type 2 diabetes. BMJ. 2018;361. DOI: https://doi.org/10.1136/bmj.k2234
Kocsis T, Molnár B, Németh D, Hegyi P, Szakács Z, Bálint A, et al. Probiotics have beneficial metabolic effects in patients with type 2 diabetes mellitus: a meta-analysis of randomized clinical trials. Sci Rep. 2020;10:11787. DOI: https://doi.org/10.1038/s41598-020-68440-1
Breton C, Šnajdrová L, Jeanneau C, Koča J, Imberty A. Structures and mechanisms of glycosyl-transferases. Glycobiology. 2006;16(2):29-37. DOI: https://doi.org/10.1093/glycob/cwj016
Taniguchi N, Honke K, Fukuda M. Handbook of glycosyltransferases and related genes (2nd ed.). Tokyo, Japan: Springer. 2002.
Han X, Shen T, Lou H. Dietary polyphenols and their biological significance. International J Mol Sci. 2007;8(9):950-88. DOI: https://doi.org/10.3390/i8090950
Sun C, Zhao C, Guven EC, Paoli P, Simal‐Gandara J, Ramkumar KM, et al. Dietary polyphenols as antidiabetic agents: Advances and opportunities. Food Front. 2020;1(1):18-44. DOI: https://doi.org/10.1002/fft2.15
Ćorković I, Gašo-Sokač D, Pichler A, Šimunović J, Kopjar M. Dietary polyphenols as natural inhibitors of α-amylase and α-glucosidase. Life. 2022;12(11):1692. DOI: https://doi.org/10.3390/life12111692
Pan YQ, Zheng QX, Jiang XM, Chen XQ, Zhang XY, Wu JL. Probiotic supplements improve blood glucose and insulin resistance/sensitivity among healthy and GDM pregnant women: a systematic review and Meta-analysis of randomized controlled trials. Evid Based Complement Alternat Med. 2021;1:7. DOI: https://doi.org/10.1155/2021/9830200
Li G, Feng H, Mao XL, Deng YJ, Wang XB, Zhang Q, et al. The effects of probiotics supplementation on glycaemic control among adults with type 2 diabetes mellitus: a systematic review and meta-analysis of randomised clinical trials. J Transl Med. 2023;21(1):442. DOI: https://doi.org/10.1186/s12967-023-04306-0
Rathi A, Potale S, Vaze R, Muley AB, Jadhav S. In vitro simulated study of macronutrient digestion in complex food using digestive enzyme supplement. Heliyon. 2024;10(9). DOI: https://doi.org/10.1016/j.heliyon.2024.e30250
Vaze R, Gadde S, Rathi A, Rathi VL, Jadhav S. Catalytic action of alternansucrase on sucrose under in vitro simulated gastric conditions. Carbohydr Res. 2024;542:109202. DOI: https://doi.org/10.1016/j.carres.2024.109202
Johnston K, Sharp P, Clifford M, Morgan L. Dietary polyphenols decrease glucose uptake by human intestinal Caco-2 cells. FEBS Lett. 2005;579:1653-7. DOI: https://doi.org/10.1016/j.febslet.2004.12.099
Manzano S, Williamson G. Polyphenols and phenolic acids from strawberry and apple decrease glucose uptake and transport by human intestinal Caco-2 cells. Mol Nutr Food Res. 2010;54:1773-80. DOI: https://doi.org/10.1002/mnfr.201000019
Sasaki M, Imaeda K, Okayama N, Mizuno T, Kataoka H, Kamiya T, et al. Effects of transglucosidase on diabetes, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes: A 12‐week, randomized, double‐blind, placebo‐controlled trial. Diabetes Obes Metab. 2012;14(4):379-82. DOI: https://doi.org/10.1111/j.1463-1326.2011.01539.x
Sasaki M, Ogasawara N, Funaki Y, Mizuno M, Iida A, Goto C, et al. Transglucosidase improves the gut microbiota profile of type 2 diabetes mellitus patients: a randomized double-blind, placebo-controlled study. BMC Gastroenterol. 2013;13:1-7. DOI: https://doi.org/10.1186/1471-230X-13-81
Shimozato A, Sasaki M, Ogasawara N, Funaki Y, Ebi M, Goto C, et al. Transglucosidase improves the bowel movements in type 2 diabetes mellitus patients: A preliminary randomized double-blind, placebo-controlled study. United European Gastroenterol J. 2017;5(6):898-907. DOI: https://doi.org/10.1177/2050640617692268
Grabež M, Škrbić R, Stojiljković MP, Vučić VM, Grujić VR, Jakovljević V, et al A prospective, randomized, double-blind, placebo-controlled trial of polyphenols on the outcomes of inflammatory factors and oxidative stress in patients with type 2 diabetes mellitus. Rev Cardiovasc Med. 2022;23(2):57. DOI: https://doi.org/10.31083/j.rcm2302057
Ghadimi M, Foroughi F, Hashemipour S, Rashidi NM, Ahmadi MH, Ahadi NB, et al. Randomized double‐blind clinical trial examining the Ellagic acid effects on glycemic status, insulin resistance, antioxidant, and inflammatory factors in patients with type 2 diabetes. Phytother Res. 2021;35(2):1023-32. DOI: https://doi.org/10.1002/ptr.6867
Mulet-Cabero AI, Egger L, Portmann R, Ménard O, Marze S, Minekus M, et al. A standardised semi-dynamic in vitro digestion method suitable for food–an international consensus. Food Funct. 2020;11(2):1702-20. DOI: https://doi.org/10.1039/C9FO01293A
Plaza-Diaz J, Gil A. Sucrose: dietary importance. Encyclopedia of food and health. Academic Press. 2016. DOI: https://doi.org/10.1016/B978-0-12-384947-2.00668-1
Bantle JP. Dietary fructose and metabolic syndrome and diabetes. J Nutr. 2009;139(6):1263S-8S. DOI: https://doi.org/10.3945/jn.108.098020
Huang Y, Chen Z, Chen B, Li J, Yuan X, Li J, et al. Dietary sugar consumption and health: umbrella review. BMJ. 2023;381. DOI: https://doi.org/10.1136/bmj-2022-071609
Bechthold A, Boeing H, Schwedhelm C, Hoffmann G, Knüppel S, Iqbal K, et al. Food groups and risk of coronary heart disease, stroke and heart failure: a systematic review and dose-response meta-analysis of prospective studies. Crit Rev Food Sci Nutr. 2019;1071-90. DOI: https://doi.org/10.1080/10408398.2017.1392288
Vinoy S, Laville M, Feskens EJ. Slow-release carbohydrates: growing evidence on metabolic responses and public health interest. Summary of the symposium held at the 12th European Nutrition Conference (FENS 2015). Food Nutr Res. 2016;60(1):31662. DOI: https://doi.org/10.3402/fnr.v60.31662
Garvey SM, Guice JL, Hollins MD, Best CH, Tinker KM. Fungal digestive enzymes promote macronutrient hydrolysis in the INFOGEST static in vitro simulation of digestion. Food Chem. 2022;386:132777. DOI: https://doi.org/10.1016/j.foodchem.2022.132777
He B, Bai X, Tan Y, Xie W, Feng Y, Yang GY. Glycosyltransferases: Mining, engineering and applications in biosynthesis of glycosylated plant natural products. Synth Syst Biotechnol. 2022;7(1):602-20. DOI: https://doi.org/10.1016/j.synbio.2022.01.001
Plou FJ, Martín MT, de Segura AG, Alcalde M, Ballesteros A. Glucosyltransferases acting on starch or sucrose for the synthesis of oligosaccharides. Can J Chem. 2002;80(6):743-52. DOI: https://doi.org/10.1139/v02-104
Qi X, Al‐Ghazzewi FH, Tester RF. Dietary fiber, gastric emptying, and carbohydrate digestion: A mini‐review. Starch‐Stärke. 2018;70(9-10):1700346. DOI: https://doi.org/10.1002/star.201700346
Chen M, Li H, Wang G, Shen X, Zhao S, Su W. Atorvastatin prevents advanced glycation end products (AGEs)-induced cardiac fibrosis via activating peroxisome proliferator-activated receptor gamma (PPAR-γ). Metabolism. 2016;65(4):441-53. DOI: https://doi.org/10.1016/j.metabol.2015.11.007
Rathi A, Pagare R, Agrawal M. Effect of GlucoSEB PB™ supplement on the blood glucose level in diabetic patients: A case study. Diabetes Res Open J. 2024;10(1):1-5.