Nutrition Research and Practice

The Korean Nutrition Society (한국영양학회)
권호 표지
DOI QR코드

DOI QR Code

Effect of diabetes-specific oral nutritional supplements with allulose on weight and glycemic profiles in overweight or obese type 2 diabetic patients

  • Jihye Tak (Department of Medical Nutrition, Graduate School of East-West Medical Science, Kyung Hee University) ;
  • Minkyung Bok (Department of Medical Nutrition, Graduate School of East-West Medical Science, Kyung Hee University) ;
  • Hyunkyung Rho (Department of Food and Nutrition, Kyung Hee University) ;
  • Ju Hyun Park (Department of Medical Nutrition, Graduate School of East-West Medical Science, Kyung Hee University) ;
  • Yunsook Lim (Department of Food and Nutrition, Kyung Hee University) ;
  • Suk Chon (Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine) ;
  • Hyunjung Lim (Department of Medical Nutrition, Graduate School of East-West Medical Science, Kyung Hee University)
  • Received : 2022.03.25
  • Accepted : 2022.09.06
  • Published : 2023.04.01
Download PDF
⟨ Previous Next ⟩

Abstract

BACKGROUND/OBJECTIVES: Diabetes-specific oral nutritional supplements (ONS) have anti-hyperglycemic effects, while D-allulose exerts anti-diabetic and anti-obesity effects. In this study, we investigated the efficacy and safety of diabetes-specific ONS, including allulose, on glycemic and weight changes in overweight or obese patients with type 2 diabetes mellitus (T2DM). SUBJECTS/METHODS: A single-arm, historical-control pilot clinical trial was conducted on 26 overweight or obese patients with T2DM (age range: 30-70 yrs). The participants were administered 2 packs of diabetes-specific ONS, including allulose (200 kcal/200 mL), every morning for 8 weeks. The glycemic profiles, obesity-related parameters, and lipid profiles were assessed to evaluate the efficacy of ONS. RESULTS: After 8 weeks, fasting blood glucose (FBG) level significantly decreased from 139.00 ± 29.66 mg/dL to 126.08 ± 32.00 mg/dL (P = 0.007) and glycosylated hemoglobin (HbA1c) improved (7.23 ± 0.82% vs. 7.03 ± 0.69%, P = 0.041). Moreover, the fasting insulin (δ: -1.81 ± 3.61 μU/mL, P = 0.017) and homeostasis model assessment for insulin resistance (HOMA-IR) (δ: -0.87 ± 1.57, P = 0.009) levels decreased at 8 weeks, and body weight significantly decreased from 67.20 ± 8.29 kg to 66.43 ± 8.12 kg (P = 0.008). Body mass index (BMI) also decreased in accordance with this (from 25.59 ± 1.82 kg/m2 to 25.30 ± 1.86 kg/m2, P = 0.009), as did waist circumference (δ: -1.31 ± 2.04 cm, P = 0.003). CONCLUSIONS: The consumption of diabetes-specific ONS with allulose in overweight or obese patients with T2DM improved glycemic profiles, such as FBG, HbA1c, and HOMA-IR, and reduced body weight and BMI.

Keywords

Acknowledgement

We are grateful to all subjects who participated in this study. We also thank all investigators involved in this project for their effort.

References

  1. World Health Organization. Global Health Estimates 2015: Deaths by Cause, Age, Sex, by Country and by Region, 2000-2015. Geneva: World Health Organization; 2016. 
  2. Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, et al. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract 2019;157:107843.
  3. Statistics Korea. Causes of death statistics [Internet]. Daejeon: Statistics Korea; 2019 [cited 2021 May 18]. Available from: https://kostat.go.kr/portal/korea/kor_nw/1/1/index.board?bmode=read&aSeq=385219. 
  4. Choi YJ, Kim HC, Kim HM, Park SW, Kim J, Kim DJ. Prevalence and management of diabetes in Korean adults: Korea National Health and Nutrition Examination Surveys 1998-2005. Diabetes Care 2009;32:2016-20. https://doi.org/10.2337/dc08-2228
  5. Jung CH, Son JW, Kang S, Kim WJ, Kim HS, Kim HS, Seo M, Shin HJ, Lee SS, Jeong SJ, et al. Diabetes fact sheets in Korea, 2020: an appraisal of current status. Diabetes Metab J 2021;45:1-10. https://doi.org/10.4093/dmj.2020.0254
  6. American Diabetes Association. 2. Classification and diagnosis of diabetes: standards of medical care in diabetes-2021. Diabetes Care 2021;44:S15-33. https://doi.org/10.2337/dc21-S002
  7. Hur KY, Moon MK, Park JS, Kim SK, Lee SH, Yun JS, Baek JH, Noh J, Lee BW, Oh TJ, et al. 2021 Clinical Practice Guidelines for diabetes mellitus of the Korean Diabetes Association. Diabetes Metab J 2021;45:461-81.  https://doi.org/10.4093/dmj.2021.0156
  8. Kang MR. Use of oral nutritional supplements for patients with diabetes. J Korean Diabetes 2017;18:181-8. https://doi.org/10.4093/jkd.2017.18.3.181
  9. de Luis DA, Izaola O, Aller R, Cuellar L, Terroba MC, Martin T, Cabezas G, Rojo S, Domingo M. A randomized clinical trial with two enteral diabetes-specific supplements in patients with diabetes mellitus type 2: metabolic effects. Eur Rev Med Pharmacol Sci 2008;12:261-6.
  10. de Luis DA, Izaola O, de la Fuente B, Terroba MC, Cuellar L, Cabezas G. A randomized clinical trial with two doses of an enteral diabetes-specific supplements in elderly patients with diabetes mellitus type 2. Eur Rev Med Pharmacol Sci 2013;17:1626-30.
  11. Mayr P, Kuhn KS, Klein P, Stover JF, Pestana EA. A diabetes-specific oral nutritional supplement improves glycaemic control in type 2 diabetes patients. Exp Clin Endocrinol Diabetes 2016;124:401-9. https://doi.org/10.1055/s-0042-100909
  12. Jiang S, Xiao W, Zhu X, Yang P, Zheng Z, Lu S, Jiang S, Zhang G, Liu J. Review on D-allulose: in vivo metabolism, catalytic mechanism, engineering strain construction, bio-production technology. Front Bioeng Biotechnol 2020;8:26.
  13. U.S. Food and Drug Administration. Generally recognized as safe [Internet]. Washington, D.C.: U.S. Food and Drug Administration; 2011 [cited 2021 May 22]. Available from: https://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&id=400. 
  14. Hossain A, Yamaguchi F, Matsuo T, Tsukamoto I, Toyoda Y, Ogawa M, Nagata Y, Tokuda M. Rare sugar D-allulose: potential role and therapeutic monitoring in maintaining obesity and type 2 diabetes mellitus. Pharmacol Ther 2015;155:49-59. https://doi.org/10.1016/j.pharmthera.2015.08.004
  15. Chung YM, Hyun Lee J, Youl Kim D, Hwang SH, Hong YH, Kim SB, Jin Lee S, Hye Park C. Dietary D-psicose reduced visceral fat mass in high-fat diet-induced obese rats. J Food Sci 2012;77:H53-8. https://doi.org/10.1111/j.1750-3841.2011.02571.x
  16. Han Y, Kwon EY, Yu MK, Lee SJ, Kim HJ, Kim SB, Kim YH, Choi MS. A preliminary study for evaluating the dose-dependent effect of D-allulose for fat mass reduction in adult humans: a randomized, double-blind, placebo-controlled trial. Nutrients 2018;10:160.
  17. Alish CJ, Garvey WT, Maki KC, Sacks GS, Hustead DS, Hegazi RA, Mustad VA. A diabetes-specific enteral formula improves glycemic variability in patients with type 2 diabetes. Diabetes Technol Ther 2010;12:419-25. https://doi.org/10.1089/dia.2009.0185
  18. Elia M, Ceriello A, Laube H, Sinclair AJ, Engfer M, Stratton RJ. Enteral nutritional support and use of diabetes-specific formulas for patients with diabetes: a systematic review and meta-analysis. Diabetes Care 2005;28:2267-79. https://doi.org/10.2337/diacare.28.9.2267
  19. Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and β-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 1985;28:412-9. https://doi.org/10.1007/BF00280883
  20. Oh JY, Yang YJ, Kim BS, Kang JH. Validity and reliability of Korean version of International Physical Activity Questionnaire (IPAQ) short form. Korean J Fam Med 2007;28:532-41. 
  21. Davis SR, Castelo-Branco C, Chedraui P, Lumsden MA, Nappi RE, Shah D, Villaseca P; Writing Group of the International Menopause Society for World Menopause Day 2012. Understanding weight gain at menopause. Climacteric 2012;15:419-29. https://doi.org/10.3109/13697137.2012.707385
  22. Weickert MO, Pfeiffer AF. Metabolic effects of dietary fiber consumption and prevention of diabetes. J Nutr 2008;138:439-42. https://doi.org/10.1093/jn/138.3.439
  23. Pohl M, Mayr P, Mertl-Roetzer M, Lauster F, Haslbeck M, Hipper B, Steube D, Tietjen M, Eriksen J, Rahlfs VW. Glycemic control in patients with type 2 diabetes mellitus with a disease-specific enteral formula: stage II of a randomized, controlled multicenter trial. JPEN J Parenter Enteral Nutr 2009;33:37-49. https://doi.org/10.1177/0148607108324582
  24. Pohl M, Mayr P, Mertl-Roetzer M, Lauster F, Lerch M, Eriksen J, Haslbeck M, Rahlfs VW. Glycaemic control in type II diabetic tube-fed patients with a new enteral formula low in carbohydrates and high in monounsaturated fatty acids: a randomised controlled trial. Eur J Clin Nutr 2005;59:1221-32.  https://doi.org/10.1038/sj.ejcn.1602232
  25. Ojo O, Weldon SM, Thompson T, Crockett R, Wang XH. The effect of diabetes-specific enteral nutrition formula on cardiometabolic parameters in patients with type 2 diabetes: a systematic review and meta-analysis of randomised controlled trials. Nutrients 2019;11:1905.
  26. Ojo O, Brooke J. Evaluation of the role of enteral nutrition in managing patients with diabetes: a systematic review. Nutrients 2014;6:5142-52. https://doi.org/10.3390/nu6115142
  27. Evert AB, Dennison M, Gardner CD, Garvey WT, Lau KH, MacLeod J, Mitri J, Pereira RF, Rawlings K, Robinson S, et al. Nutrition therapy for adults with diabetes or prediabetes: a consensus report. Diabetes Care 2019;42:731-54. https://doi.org/10.2337/dci19-0014
  28. Qian F, Korat AA, Malik V, Hu FB. Metabolic effects of monounsaturated fatty acid-enriched diets compared with carbohydrate or polyunsaturated fatty acid-enriched diets in patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes Care 2016;39:1448-57. https://doi.org/10.2337/dc16-0513
  29. Huo R, Du T, Xu Y, Xu W, Chen X, Sun K, Yu X. Effects of Mediterranean-style diet on glycemic control, weight loss and cardiovascular risk factors among type 2 diabetes individuals: a meta-analysis. Eur J Clin Nutr 2015;69:1200-8. https://doi.org/10.1038/ejcn.2014.243
  30. Ye Z, Arumugam V, Haugabrooks E, Williamson P, Hendrich S. Soluble dietary fiber (Fibersol-2) decreased hunger and increased satiety hormones in humans when ingested with a meal. Nutr Res 2015;35:393-400. https://doi.org/10.1016/j.nutres.2015.03.004
  31. Han JH, Lee KH, Sohn HS, Lee YB, Park JS, Oh MJ. Evaluation of enteral foods prepared with soybean dietary fiber for patients with diarrhea. Korean J Agric Sci 2008;35:41-51. 
  32. Howarth NC, Saltzman E, Roberts SB. Dietary fiber and weight regulation. Nutr Rev 2001;59:129-39. https://doi.org/10.1111/j.1753-4887.2001.tb07001.x
  33. Magnoni D, Rouws CH, Lansink M, van Laere KM, Campos AC. Long-term use of a diabetes-specific oral nutritional supplement results in a low-postprandial glucose response in diabetes patients. Diabetes Res Clin Pract 2008;80:75-82. https://doi.org/10.1016/j.diabres.2007.10.027
  34. Vaisman N, Lansink M, Rouws CH, van Laere KM, Segal R, Niv E, Bowling TE, Waitzberg DL, Morley JE. Tube feeding with a diabetes-specific feed for 12 weeks improves glycaemic control in type 2 diabetes patients. Clin Nutr 2009;28:549-55. https://doi.org/10.1016/j.clnu.2009.05.004
  35. Mustad VA, Hegazi RA, Hustead DS, Budiman ES, Rueda R, Maki K, Powers M, Mechanick JI, Bergenstal RM, Hamdy O. Use of a diabetes-specific nutritional shake to replace a daily breakfast and afternoon snack improves glycemic responses assessed by continuous glucose monitoring in people with type 2 diabetes: a randomized clinical pilot study. BMJ Open Diabetes Res Care 2020;8:e001258.
  36. Pedersen E, Lange K, Clifton P. Effect of carbohydrate restriction in the first meal after an overnight fast on glycemic control in people with type 2 diabetes: a randomized trial. Am J Clin Nutr 2016;104:1285-91. https://doi.org/10.3945/ajcn.116.135343
  37. Monnier L, Colette C, Dejager S, Owens D. Magnitude of the dawn phenomenon and its impact on the overall glucose exposure in type 2 diabetes: is this of concern? Diabetes Care 2013;36:4057-62. https://doi.org/10.2337/dc12-2127
  38. Franc S, Dardari D, Peschard C, Riveline JP, Biedzinski M, Boucherie B, Petit C, Requeda E, Mistretta F, Varroud-Vial M, et al. Can postprandial blood glucose excursion be predicted in type 2 diabetes? Diabetes Care 2010;33:1913-8. https://doi.org/10.2337/dc10-0115
  39. Kim EK, Kim OY, Park J, Kim E, Kim J. Establishment and future tasks of estimated energy requirement in 2020 dietary reference intakes for Koreans. J Nutr Health 2021;54:573-83. https://doi.org/10.4163/jnh.2021.54.6.573
  40. Bonelli A, Menna P, Minotti G, Angeletti S, Comandini A, Picollo R, Quarchioni E, Russo V, Salvatori E, Ferravante F, et al. Safety and tolerability of a novel oral nutritional supplement in healthy volunteers. Clin Nutr 2021;40:946-55. https://doi.org/10.1016/j.clnu.2020.06.022