Back ground: A balanced diet with a low glycemic index (GI) plays an important role in controlling and managing type 2 diabetes mellitus (T2DM). Here, we compared the GI of 2 flavors (vanilla and chocolate) of diabetes-specific nutritional (DSN) supplements to its comparator in healthy Indian adults under fasting conditions. Methods: This study was a 39-day open-label, non-comparati ve, single-center trial involving healthy adults aged between 18 to 45 years. The subjects received equal doses of 2 DSN powder (Treatments A and B), the comparator product (Treatment C), and dextrose monohydrate as a reference (Treatment R). Doses were administered as per the dosing schedule, after an overnight fast for 10 hours, with 2 intervening non-dosing days. Blood samples were collected on the dosing days to assess changes in capillary blood glucose levels. The primary endpoint of the study was the mean GI of Treatments A, B, and C (Defined as low: GI ≤ 55; medium: 55 < GI ≤ 70; High: GI > 70), generated using the incremental area under the curve (AUC i ) methodology. Safety was assessed throughout the study. Values of all study parameters were represented in ±SD or standard deviation. Results: Fourteen adult male subjects with a mean age of 29.42 ± 4.46 years, and a body mass index of 22.0 ± 1.95 Kg/m 2 , were enrolled in the study. The mean AUC i for treatments A, B, and C were 104 ± 10, 111 ± 12, and 87 ± 12 mmol min/L, respectively and for Treatment R it was 276 ± 16, 319 ± 28 and 338 ± 25 mmol min/L for Days 1, 6 and 8, respectively. The mean GI of Treatment A was 33 ± 3, Treatment B was 35 ± 3 and Treatment C was 29 ± 5; all GI means were ≤55. Mild adverse events were reported in 2 (14.3%) subjects. No serious adverse events or deaths were reported in the study. All treatments were well tolerated by the subjects. Conclusion: The glycemic index of both test products and comparator was low ( i.e. , GI < 55) as per ISO 26642:2010 standard.
Pradeepa, R. and Mohan, V. (2017) Prevalence of Type 2 Diabetes and Its Complications in India and Economic Costs to the Nation. European Journal of Clinical Nutrition, 71, 816-824. https://doi.org/10.1038/ejcn.2017.40
Hu, F.B. (2011) Globalization of Diabetes: The Role of Diet, Lifestyle, and Genes. Diabetes Care, 34, 1249-1257. https://doi.org/10.2337/dc11-0442
Forouhi, N.G., Misra, A., Mohan, V., Taylor, R. and Yancy, W. (2018) Dietary and Nutritional Approaches for Prevention and Management of Type 2 Diabetes. BMJ, 361, k2234. https://doi.org/10.1136/bmj.k2234
Mohan, V., Shah, S.N., Joshi, S.R., Seshiah, V., Sahay, B.K., Banerjee, S., Wangnoo, S.K., Kumar, A., Kalra, S., Unnikrishnan, A.G., Sharma, S.K., Rao, P.V., Akhtar, S., Shetty, R.V., Das, A.K. and DiabCare India 2011 Study Group (2014) Current Status of Management, Control, Complications and Psychosocial Aspects of Patients with Diabetes in India: Results from the DiabCare India 2011 Study. Indian Journal of Endocrinology and Metabolism, 18, 370-378. https://doi.org/10.4103/2230-8210.129715
Lianov, L. and Johnson, M. (2010) Physician Competencies for Prescribing Lifestyle Medicine. JAMA, 304, 202-203. https://doi.org/10.1001/jama.2010.903
Kahan, S. and Manson, J.E. (2017) Nutrition Counseling in Clinical Practice: How Clinicians Can Do Better. JAMA, 318, 1101-1102. https://doi.org/10.1001/jama.2017.10434
Basu, S. and Sharma, N. (2019) Diabetes Self-Care in Primary Health Facilities in India—Challenges and the Way Forward. World Journal of Diabetes, 10, 341-349. https://doi.org/10.4239/wjd.v10.i6.341
Varadaraj, G., Sangeetha, B., Nithiya, D.R. and Dixit, P.K. (2021) Effectiveness of Medical Nutritional Therapy in the Management of Type 2 Diabetes Mellitus. The Journal of the Association of Physicians of India, 69, 11-12.
Vetter, M.L., Amaro, A. and Volger, S. (2014) Nutritional Management of Type 2 Diabetes Mellitus and Obesity and Pharmacologic Therapies to Facilitate Weight Loss. Postgraduate Medicine, 126, 139-152. https://doi.org/10.3810/pgm.2014.01.2734
Mozaffarian, D. (2016) Dietary and Policy Priorities for Cardiovascular Disease, Diabetes, and Obesity. A Comprehensive Review. Circulation, 133, 187-225. https://doi.org/10.1161/CIRCULATIONAHA.115.018585
Ley, S.H., Hamdy, O., Mohan, V. and Hu, F.B. (2014) Prevention and Management of Type 2 Diabetes: Dietary Components and Nutritional Strategies. The Lancet, 383, 1999-2007. https://doi.org/10.1016/S0140-6736(14)60613-9
Evert, A.B., Boucher, J.L., Cypress, M., Dunbar, S.A., Franz, M.J., Mayer-Davis, E.J., Neumiller, J.J., Nwankwo, R., Verdi, C.L., Urbanski, P., Yancy Jr., W.S., and American Diabetes Association (2013) Nutrition Therapy Recommendations for the Management of Adults with Diabetes. Diabetes Care, 36, 3821-3842. https://doi.org/10.2337/dc13-2042
Canadian Diabetes Association Clinical Practice Guidelines Expert Committee, Dworatzek, P.D., Arcudi, K., Gougeon, R., Husein, N., Sievenpiper, J.L. and Williams, S.L. (2013) Nutrition Therapy. Canadian Journal of Diabetes, 37, S45-S55. https://doi.org/10.1016/j.jcjd.2013.01.019
Ajala, O., English, P. and Pinkney, J. (2013) Systematic Review and Meta-Analysis of Different Dietary Approaches to the Management of Type 2 Diabetes. The American Journal of Clinical Nutrition, 97, 505-516. https://doi.org/10.3945/ajcn.112.042457
Wheeler, M.L., Dunbar, S.A., Jaacks, L.M., Karmally, W., Mayer-Davis, E.J., Wylie-Rosett, J. and Yancy Jr., W.S. (2012) Macronutrients, Food Groups, and Eating Patterns in the Management of Diabetes: A Systematic Review of the Literature, 2010. Diabetes Care, 35, 434-445. https://doi.org/10.2337/dc11-2216
Dyson, P.A., Kelly, T., Deakin, T., Duncan, A., Frost, G., Harrison, Z., Khatri, D., Kunka, D., McArdle, P., Mellor, D., Oliver, L., Worth, J. and Diabetes UK Nutrition Working Group (2011) Diabetes UK Evidence-Based Nutrition Guidelines for the Prevention And Management of Diabetes. Diabetic Medicine, 28, 1282-1288. https://doi.org/10.1111/j.1464-5491.2011.03371.x
Franz, M.J., MacLeod, J., Evert, A., Brown, C., Gradwell, E., Handu, D., Reppert, A. and Robinson, M. (2017) Academy of Nutrition and Dietetics Nutrition Practice Guideline for Type 1 and Type 2 Diabetes in Adults: Systematic Review of Evidence for Medical Nutrition Therapy Effectiveness and Recommendations for Integration into the Nutrition Care Process. Journal of the Academy of Nutrition and Dietetics, 117, 1659-1679. https://doi.org/10.1016/j.jand.2017.03.022
Schwingshackl, L., Hoffmann, G., Lampousi, A.M., Knüppel, S., Iqbal, K., Schwedhelm, C., Bechthold, A., Schlesinger, S. and Boeing, H. (2017) Food Groups and Risk of Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Prospective Studies. European Journal of Epidemiology, 32, 363-375. https://doi.org/10.1007/s10654-017-0246-y
Russell, W.R., Baka, A., Bjorck, I., Delzenne, N., Gao, D., Griffiths, H.R., Hadjilucas, E., Juvonen, K., Lahtinen, S., Lansink, M., Loon, L.V., Mykkanen, H., Ostman, E., Riccardi, G., Vinoy, S. and Weickert, M.O. (2016) Impact of Diet Composition on Blood Glucose Regulation. Critical Reviews in Food Science and Nutrition, 56, 541-590. https://doi.org/10.1080/10408398.2013.792772
Sylvetsky, A.C., Edelstein, S.L., Walford, G., Boyko, E.J., Horton, E.S., Ibebuogu, U.N., Knowler, W.C., Montez, M.G., Temprosa, M., Hoskin, M., Rother, K.I., Delahanty, L.M. and Diabetes Prevention Program Research Group (2017) A High-Carbohydrate, High-Fiber, Low-Fat Diet Results in Weight Loss among Adults at High Risk of Type 2 Diabetes. The Journal of Nutrition, 147, 2060-2066. https://doi.org/10.3945/jn.117.252395
Zanini, A.C., Dos Santos, H., Celes, A. and Giuntini, E.B. (2022) Letter to the Editor about “Determination of Glycemic Index of Enteral Formulas Used in Clinical Practice” by Tosatti JAG, Bocardi VB, Jansen AK, Bernandes H, Silva FM Published on March 2020. International Journal of Food Sciences and Nutrition, 73, 705-707. https://doi.org/10.1080/09637486.2022.2044765
Esfahani, A., Wong, J.M., Mirrahimi, A., Srichaikul, K., Jenkins, D.J. and Kendall, C.W. (2009) The Glycemic Index: Physiological Significance. Journal of the American College of Nutrition, 28, 439S-445S. https://doi.org/10.1080/07315724.2009.10718109
Zafar, M.I., Mills, K.E., Zheng, J., Regmi, A., Hu, S.Q., Gou, L. and Chen, L.L. (2019) Low-Glycemic Index Diets as an Intervention for Diabetes: A Systematic Review and Meta-Analysis. The American Journal of Clinical Nutrition, 110, 891-902. https://doi.org/10.1093/ajcn/nqz149
Wolever, T.M. and Mehling, C. (2003) Long-Term Effect of Varying the Source or Amount of Dietary Carbohydrate on Postprandial Plasma Glucose, Insulin, Triacylglycerol, and Free Fatty Acid Concentrations in Subjects with Impaired Glucose Tolerance. The American Journal of Clinical Nutrition, 77, 612-621. https://doi.org/10.1093/ajcn/77.3.612
Jenkins, D.J., Kendall, C.W., McKeown-Eyssen, G., Josse, R.G., Silverberg, J., Booth, G.L., Vidgen, E., Josse, A.R., Nguyen, T.H., Corrigan, S., Banach, M.S., Ares, S., Mitchell, S., Emam, A., Augustin, L.S., Parker, T.L. and Leiter, L.A. (2008) Effect of a Low-Glycemic Index or a High-Cereal Fiber Diet on Type 2 Diabetes: A Randomized Trial. JAMA, 300, 2742-2753. https://doi.org/10.1001/jama.2008.808
Sun, Q., Spiegelman, D., van Dam, R.M., Holmes, M.D., Malik, V.S., Willett, W.C. and Hu, F.B. (2010) White Rice, Brown Rice, and Risk of Type 2 Diabetes in US Men and Women. Archives of Internal Medicine, 170, 961-969. https://doi.org/10.1001/archinternmed.2010.109
Villegas, R., Liu, S., Gao, Y.T., Yang, G., Li, H., Zheng, W. and Shu, X.O. (2007) Prospective Study of Dietary Carbohydrates, Glycemic Index, Glycemic Load, and Incidence of Type 2 Diabetes Mellitus in Middle-Aged Chinese Women. Archives of Internal Medicine, 167, 2310-2316. https://doi.org/10.1001/archinte.167.21.2310
National Sample Survey 2011-2012 (68th Round)—Schedule 1.0 (Type 1)—Consumer Expenditure. International Household Survey Network. https://catalog.ihsn.org/index.php/catalog/3281
Misra, A., Singhal, N., Sivakumar, B., Bhagat, N., Jaiswal, A. and Khurana, L. (2011) Nutrition Transition in India: Secular Trends in Dietary Intake and Their Relationship to Diet-Related Non-Communicable Diseases. Journal of Diabetes, 3, 278-292. https://doi.org/10.1111/j.1753-0407.2011.00139.x
Downs, S.M., Singh, A., Gupta, V., Lock, K. and Ghosh-Jerath, S. (2015) The Need for Multisectoral Food Chain Approaches to Reduce Trans Fat Consumption in India. BMC Public Health, 15, Article No. 693. https://doi.org/10.1186/s12889-015-1988-7
León-Sanz, M., García-Luna, P.P., Sanz-París, A., Gómez-Candela, C., Casimiro, C., Chamorro, J., Pereira-Cunill, J.L., Martin-Palmero, A., Trallero, R., Martínez, J., Ordónez, F.J., García-Peris, P., Camarero, E., Gómez-Enterría, P., Cabrerizo, L., Perez-de-la-Cruz, A., Sánchez, C., García-de-Lorenzo, A., Rodríguez, N., Usán, L., Abbott SPAI-97-004 Study Cooperative Group (2005) Glycemic and Lipid Control in Hospitalized Type 2 Diabetic Patients: Evaluation of 2 Enteral Nutrition Formulas (Low Carbohydrate-High Monounsaturated Fat vs High Carbohydrate). Journal of Parenteral and Enteral Nutrition, 29, 21-29. https://doi.org/10.1002/j.1941-2444.2005.tb04841.x
van Steen, S.C., Rijkenberg, S., Sechterberger, M.K., DeVries, J.H. and van der Voort, P.H.J. (2018) Glycemic Effects of a Low-Carbohydrate Enteral Formula Compared With an Enteral Formula of Standard Composition in Critically Ill Patients: An Open-Label Randomized Controlled Clinical Trial. Journal of Parenteral and Enteral Nutrition, 42, 1035-1045. https://doi.org/10.1002/jpen.1045
Peters, A.L. and Davidson, M.B. (1992) Effects of Various Enteral Feeding Products on Postprandial Blood Glucose Response in Patients with Type I Diabetes. Journal of Parenteral and Enteral Nutrition, 16, 69-74. https://doi.org/10.1177/014860719201600169
Wang, W.Q., Zhang, Y.F., Zhou, D.J., Liu, Z.M., Hong, X., Qiu, M.C., Shi, Y.Q., Xia, P.J., Lu, J., Xu, M.J., An, L., Feng, W., Zhang, P., Schwamman, J. and Ning, G. (2008) Open-Label, Randomized, Multiple-Center, Parallel Study Comparing Glycemic Responses and Safety Profiles of Glucerna versus Fresubin in Subjects of Type 2 Diabetes Mellitus. Endocrine, 33, 45-52. https://doi.org/10.1007/s12020-008-9059-9
International Standard ISO 26642 Food Products—Determination of the Glycaemic Index (GI) and Recommendation for Food Classification (2010). https://cdn.standards.iteh.ai/samples/43633/7bfdd738c48247d39e08d1205c80b00d/ISO-26642-2010.pdf
Prohance D Protein Powder for Diabetics. https://prohance.in/nutrition-products/prohance-d/protein-powder-for-diabetics
Carbohydrates in Human Nutrition. Report of a Joint FAO/WHO Expert Consultation (1997). https://www.fao.org/3/w8079e/w8079e00.htm
Livesey, G., Taylor, R., Hulshof, T. and Howlett, J. (2008) Glycemic Response and Health—A Systematic Review and Meta-Analysis: Relations between Dietary Glycemic Properties and Health Outcomes. The American Journal of Clinical Nutrition, 87, S258-S268. https://doi.org/10.1093/ajcn/87.1.258S
Silva, F.M., Kramer, C.K., Crispim, D. and Azevedo, M.J. (2015) A high-Glycemic Index, Low-Fiber Breakfast Affects the Postprandial Plasma Glucose, Insulin, and Ghrelin Responses of Patients with Type 2 Diabetes in a Randomized Clinical Trial. The Journal of Nutrition, 145, 736-741. https://doi.org/10.3945/jn.114.195339
Lobos, D.R., Vicuna, I.A., Novik, V. and Vega, C.A. (2017) Effect of High and Low Glycemic Index Breakfast on Postprandial Metabolic Parameters and Satiety in Subjects with Type 2 Diabetes Mellitus under Intensive Insulin Therapy: Controlled Clinical Trial. Clinical Nutrition ESPEN, 20, 12-16. https://doi.org/10.1016/j.clnesp.2017.04.082
Augustin, L., Kendall, C., Jenkins, D., Willett, W.C., Astrup, A., Barclay, A.W., Bjorck, I., Brand-Miller, J.C., Brighenti, F., Buyken, A.E., Ceriello, A., La Vecchia, C., Livesey, G., Liu, S., Riccardi, G., Rizkalla, S.W., Sievenpiper, J.L., Trichopoulou, A., Wolever, T., Baer-Sinnott, S. and Poli, A. (2015) Glycemic Index, Glycemic Load and Glycemic Response: An International Scientific Consensus Summit from the International Carbohydrate Quality Consortium (ICQC). Nutrition, Metabolism, and Cardiovascular Diseases, 25, 795-815. https://doi.org/10.1016/j.numecd.2015.05.005
ICMR Guidelines for Management of Type 2 Diabetes 2018 (2018). https://main.icmr.nic.in/sites/default/files/guidelines/ICMR_GuidelinesType2diabetes2018_0.pdf
Singh, R.B., Rastogi, S.S., Rao, P.V., Das, S., Madhu, S.V., Das, A.K., Sahay, B.K., Fuse, S.M., Beegom, R., Sainani, G.S. and Shah, N.A. (1997) Diet and Lifestyle Guidelines and Desirable Levels of Risk Factors for the Prevention of Diabetes and Its Vascular Complications in Indians: A Scientific Statement of the International College of Nutrition. Indian Consensus Group for the Prevention of Diabetes. Journal of Cardiovascular Risk, 4, 201-208. https://doi.org/10.1097/00043798-199706000-00007
Kapur, K., Kapur, A., Ramachandran, S., Mohan, V., Aravind, S.R., Badgandi, M. and Srishyla, M.V. (2008) Barriers to Changing Dietary Behavior. The Journal of the Association of Physicians of India, 56, 27-32.
Kim, J. and Hur, M.H. (2021) The Effects of Dietary Education Interventions on Individuals with Type 2 Diabetes: A Systematic Review and Meta-Analysis. International Journal of Environmental Research and Public Health, 18, Article 8439. https://doi.org/10.3390/ijerph18168439
Briggs Early, K. and Stanley, K. (2018) Position of the Academy of Nutrition and Dietetics: The Role of Medical Nutrition Therapy and Registered Dietitian Nutritionists in the Prevention and Treatment of Prediabetes and Type 2 Diabetes. Journal of the Academy of Nutrition and Dietetics, 118, 343-353. https://doi.org/10.1016/j.jand.2017.11.021
Wang, Q., Xia, W., Zhao, Z. and Zhang, H. (2015) Effects Comparison between Low Glycemic Index Diets and High Glycemic Index Diets on HbA1c and Fructosamine for Patients with Diabetes: A Systematic Review and Meta-Analysis. Primary Care Diabetes, 9, 362-369. https://doi.org/10.1016/j.pcd.2014.10.008
Lingegowda, V. (2009) Review: Low Glycaemic-Index Diets Reduce HbA1c More Than High Glycaemic-Index Diets in Diabetes Mellitus. Evidence-Based Medicine, 14, Article 106. https://doi.org/10.1136/ebm.14.4.106
Erbe, J.K. (2009) Low Glycemic Index Diets for the Management of Diabetes. American Family Physician, 80, 941-942.
Thomas, D. and Elliott, E.J. (2009) Low Glycaemic Index, or Low Glycaemic Load, Diets for Diabetes Mellitus. The Cochrane Database of Systematic Reviews, No. 1, CD006296. https://doi.org/10.1002/14651858.CD006296.pub2
Li, D., Zhang, P., Guo, H. and Ling, W. (2014) Taking a Low Glycemic Index Multi-Nutrient Supplement as Breakfast Improves Glycemic Control in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial. Nutrients, 6, 5740-5755. https://doi.org/10.3390/nu6125740
Chiavaroli, L., Lee, D., Ahmed, A., Cheung, A., Khan, T.A., Blanco, S., Mejia, Mirrahimi, A., Jenkins, D.J.A., Livesey, G., Wolever, T.M.S., Rahelic, D., Kahleová, H., Salas-Salvadó, J., Kendall, C.W.C. and Sievenpiper, J.L. (2021) Effect of Low Glycaemic Index or Load Dietary Patterns on Glycaemic Control and Cardiometabolic Risk Factors in Diabetes: Systematic Review and Meta-Analysis of Randomised Controlled Trials. BMJ, 374, n1651. https://doi.org/10.1136/bmj.n1651