Efficacy of a Diabetes Specific Nutrition Supplement on Glycemic, Anthropometric, Dietary and Gut Health Markers in Adults with Type 2 Diabetes: An RCT
With increasing incidence of diabetes, use of diabetes specific nutrition supplements (DSNS) is common for better management of the disease. To study effect of 12-week DSNS supplementation on glycemic markers, anthropometry, lipid profile, SCFAs, and gut microbiome in individuals with diabetes. Markers studied were glycemic [Fasting Blood Glucose (FBG), Post Prandial Glucose (PPG), HbA1c, Incremental Area under curve (iAUC), Mean Amplitude of Glycemic Excursions (MAGE), Time in/above Range (TIR/TAR)], anthropometry [weight, Body Mass Index (BMI), waist circumference (WC)], lipid profile, diet and gut health [plasma short chain fatty acids (SCFAs)]. N = 210 adults were randomized to receive either DSNS with standard care (DSNS + SC; n = 105) or standard care alone (SC alone; n = 105). After 12 weeks, significant differences between DSNS + SC versus SC alone was observed in FBG [？3 ± 6 vs 14 ± 6 mg/dl; p = 0.03], PPG [？35 ± 9 vs ？3 ± 9 mg/dl; p = 0.01], weight [？0.6 ± 0.1 vs 0.2 ± 0.1 kg; p = 0.0001], BMI [？0.3 ± 0.1 vs 0.1 ± 0.1 kg/m2; p = 0.0001] and WC [？0.3 ± 0.2 vs 0.2 ± 0.2 cm; p = 0.01]. HbA1C and low-density lipoprotein (LDL) were significantly reduced in DSNS + SC [？0.2 ± 0.9; p = 0.04 and ？5 mg/dl; p = 0.03] respectively with no change in control. Continuous Glucose Monitoring (CGM) reported significant differences between DSNS + SC versus SC alone for mean glucose [？12 ± 65 vs 28 ± 93 mg/dl; p < 0.01], TAR 180 [？9 ± 42 vs 7 ± 45 mg/dl; p = 0.04], TAR 250 [？3 ± 27 vs 9 ± 38 mg/dl; p = 0.05], iAUC [？192 (1.1) vs ？48 (1.1) mg/dl; p = 0.03]. MAGE was significantly reduced for both DSNS + SC (？19 ± 67; p < 0.001) and SC alone (？8 ± 70; p = 0.04), with reduction being more pronounced for DSNS + SC. DSNS + SC reported a decrease in carbohydrate energy % [？9.4 (？11.3, ？7.6) %; p < 0.0001] and amount [？47.4 (？67.1, ？27.7) g; p < 0.0001], increased dietary fiber [9.5 (7.2, 11.8) g; p < 0.0001] and protein energy % [0.9 (0.5, 1.3) %; p < 0.0001] versus SC alone. DSNS + SC reported significant increases versus SC alone in total (0.3 ng/ml; p = 0.03) and individual plasma SCFAs. The consumption of DSNS significantly improves the glycemic, anthropometric, dietary, and gut health markers in diabetes.
References
[1]
Viswanathan, V., Krishnan, D., Kalra, S., Chawla, R., Tiwaskar, M., Saboo, B., et al. (2019) Insights on Medical Nutrition Therapy for Type 2 Diabetes Mellitus: An Indian Perspective. Advances in Therapy, 36, 520-547. https://doi.org/10.1007/s12325-019-0872-8
[2]
Arokiasamy, P. (2018) India’s Escalating Burden of Non-Communicable Diseases. The Lancet Global Health, 6, e1262-e1263. https://doi.org/10.1016/s2214-109x(18)30448-0
[3]
Tandon, N., Anjana, R.M., Mohan, V., Kaur, T., Afshin, A., Ong, K., et al. (2018) The Increasing Burden of Diabetes and Variations among the States of India: The Global Burden of Disease Study 1990-2016. The Lancet Global Health, 6, e1352-e1362. https://doi.org/10.1016/s2214-109x(18)30387-5
[4]
International Diabetes Federation (2021) IDF Diabetes Atlas. https://www.diabetesatlas.org
[5]
Anjana, R.M., Unnikrishnan, R., Deepa, M., Pradeepa, R., Tandon, N., Das, A.K., et al. (2023) Metabolic Non-Communicable Disease Health Report of India: The ICMR-INDIAB National Cross-Sectional Study (ICMR-INDIAB-17). The Lancet Diabetes & Endocrinology, 11, 474-489. https://doi.org/10.1016/s2213-8587(23)00119-5
[6]
Wild, S.H. and Byrne, C.D. (2006) Risk Factors for Diabetes and Coronary Heart Disease. BMJ, 333, 1009-1011. https://doi.org/10.1136/bmj.39024.568738.43
[7]
Tripathy, J.P. (2018) Burden and Risk Factors of Diabetes and Hyperglycemia in India: Findings from the Global Burden of Disease Study 2016. Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 11, 381-387. https://doi.org/10.2147/dmso.s157376
[8]
Kota, S., Satya Krishna, S. and Modi, K. (2013) Glycemic Variability: Clinical Implications. Indian Journal of Endocrinology and Metabolism, 17, 611-619. https://doi.org/10.4103/2230-8210.113751
[9]
Green, H.L.H. and Brewer, A.C. (2020) Dysregulation of 2-Oxoglutarate-Dependent Dioxygenases by Hyperglycaemia: Does This Link Diabetes and Vascular Disease? Clinical Epigenetics, 12, Article No. 59. https://doi.org/10.1186/s13148-020-00848-y
[10]
Franz, M.J. (1997) Lifestyle Modifications for Diabetes Management. Endocrinology and Metabolism Clinics of North America, 26, 499-510. https://doi.org/10.1016/s0889-8529(05)70263-2
[11]
Magkos, F., Yannakoulia, M., Chan, J.L. and Mantzoros, C.S. (2009) Management of the Metabolic Syndrome and Type 2 Diabetes through Lifestyle Modification. Annual Review of Nutrition, 29, 223-256. https://doi.org/10.1146/annurev-nutr-080508-141200
[12]
Mechanick, J.I., Marchetti, A., Hegazi, R. and Hamdy, O. (2020) Diabetes-Specific Nutrition Formulas in the Management of Patients with Diabetes and Cardiometabolic Risk. Nutrients, 12, Article 3616. https://doi.org/10.3390/nu12123616
[13]
Evert, A.B., Dennison, M., Gardner, C.D., Garvey, W.T., Lau, K.H.K., MacLeod, J., et al. (2019) Nutrition Therapy for Adults with Diabetes or Prediabetes: A Consensus Report. Diabetes Care, 42, 731-754. https://doi.org/10.2337/dci19-0014
[14]
Elia, M., Ceriello, A., Laube, H., Sinclair, A.J., Engfer, M. and Stratton, R.J. (2005) Enteral Nutritional Support and Use of Diabetes-Specific Formulas for Patients with Diabetes. Diabetes Care, 28, 2267-2279. https://doi.org/10.2337/diacare.28.9.2267
[15]
Nogal, A., Valdes, A.M. and Menni, C. (2021) The Role of Short-Chain Fatty Acids in the Interplay between Gut Microbiota and Diet in Cardio-Metabolic Health. Gut Microbes, 13, Article 1897212. https://doi.org/10.1080/19490976.2021.1897212
[16]
Bhoite, R., Chandrasekaran, A., Pratti, V.L., Satyavrat, V., Aacharya, S., Mane, A., et al. (2021) Effect of a High-Protein High-Fibre Nutritional Supplement on Lipid Profile in Overweight/Obese Adults with Type 2 Diabetes Mellitus: A 24-Week Randomized Controlled Trial. Journal of Nutrition and Metabolism, 2021, Article 6634225. https://doi.org/10.1155/2021/6634225
[17]
Mohan, V., Kalpana, N., Lakshmipriya, N., Anitha, P., Gayathri, R., Vijayalakshmi, P., et al. (2019) A Pilot Study Evaluating the Effects of Diabetes Specific Nutrition Supplement and Lifestyle Intervention on Glycemic Control in Overweight and Obese Asian Indian Adults with Type 2 Diabetes Mellitus. Journal of the Association of Physicians of India, 67, 25-30.
[18]
Sun, J., Wang, Y., Chen, X., Chen, Y., Feng, Y., Zhang, X., et al. (2008) An Integrated Intervention Program to Control Diabetes in Overweight Chinese Women and Men with Type 2 Diabetes. Asia Pacific Journal of Clinical Nutrition, 17, 514-524.
[19]
Tatti, P., di Mauro, P., Neri, M., Pipicelli, G. and Mussad, V.A. (2009) Effect of a Low-Calorie High Nutritional Value Formula on Weight Loss in Type 2 Diabetes Mellitus. Mediterranean Journal of Nutrition and Metabolism, 3, 65-69. https://doi.org/10.1007/s12349-009-0050-7
[20]
Khanna, D., Reddy, K.J., Gopalan, H.S., Bhatt, J., Gupta, J., Sethi, S., et al. (2024) Efficacy of a Diabetes Specific Nutritional Supplement (DSNS) on Glycemic Response in Prediabetic Adults: A Two-Armed, Open-Labelled Randomized Controlled Study. Food and Nutrition Sciences, 15, 612-643. https://doi.org/10.4236/fns.2024.157040
[21]
Patel, K., Kudrigikar, V., Bachani, D. and Mehta, S. (2023) Glycemic Index of a Diabetes-Specific Nutritional Powder: An Open-Label Study in Healthy Indian Adults. Food and Nutrition Sciences, 14, 200-224. https://doi.org/10.4236/fns.2023.143014
[22]
Vijayananthan, A. and Nawawi, O. (2008) The Importance of Good Clinical Practice Guidelines and Its Role in Clinical Trials. Biomedical Imaging and Intervention Journal, 4, e5. https://doi.org/10.2349/biij.4.1.e5
[23]
Khanna, D., Bhatt, J., Gupta, J., Sethi, S., Joshi, P., Pareek, M., et al. (2023) Glycemic Indices of Multiple Oral Nutritional Supplements: A Randomized Cross-Over Study in Indian Adults. Food and Nutrition Sciences, 14, 941-962. https://doi.org/10.4236/fns.2023.1410060
[24]
Anjana, R.M., Srinivasan, S., Sudha, V., Joshi, S.R., Saboo, B., Tandon, N., et al. (2022) Macronutrient Recommendations for Remission and Prevention of Diabetes in Asian Indians Based on a Data-Driven Optimization Model: The ICMR-INDIAB National Study. Diabetes Care, 45, 2883-2891. https://doi.org/10.2337/dc22-0627
[25]
Schulz, K.F., Altman, D.G. and Moher, D. (2010) CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. BMC Medicine, 8, Article No. 18. https://doi.org/10.1186/1741-7015-8-18
[26]
Anderson, J.W., Baird, P., Davis Jr, R.H., Ferreri, S., Knudtson, M., Koraym, A., et al. (2009) Health Benefits of Dietary Fiber. Nutrition Reviews, 67, 188-205. https://doi.org/10.1111/j.1753-4887.2009.00189.x
[27]
Slavin, J.L. (2005) Dietary Fiber and Body Weight. Nutrition, 21, 411-418. https://doi.org/10.1016/j.nut.2004.08.018
[28]
Piconi, L., Quagliaro, L., Assaloni, R., Da Ros, R., Maier, A., Zuodar, G., et al. (2006) Constant and Intermittent High Glucose Enhances Endothelial Cell Apoptosis through Mitochondrial Superoxide Overproduction. Diabetes/Metabolism Research and Reviews, 22, 198-203. https://doi.org/10.1002/dmrr.613
[29]
Giuntini, E.B., Sardá, F.A.H. and de Menezes, E.W. (2022) The Effects of Soluble Dietary Fibers on Glycemic Response: An Overview and Futures Perspectives. Foods, 11, Article 3934. https://doi.org/10.3390/foods11233934
[30]
Suh, S. and Kim, J.H. (2015) Glycemic Variability: How Do We Measure It and Why Is It Important? Diabetes & Metabolism Journal, 39, 273-282. https://doi.org/10.4093/dmj.2015.39.4.273
[31]
Ravi, R., Balasubramaniam, V., Kuppusamy, G. and Ponnusankar, S. (2021) Current Concepts and Clinical Importance of Glycemic Variability. Diabetes & Metabolic Syndrome: Clinical Research & Reviews, 15, 627-636. https://doi.org/10.1016/j.dsx.2021.03.004
[32]
Akasaka, T., Sueta, D., Tabata, N., Takashio, S., Yamamoto, E., Izumiya, Y., et al. (2017) Effects of the Mean Amplitude of Glycemic Excursions and Vascular Endothelial Dysfunction on Cardiovascular Events in Nondiabetic Patients with Coronary Artery Disease. Journal of the American Heart Association, 6, e004841. https://doi.org/10.1161/jaha.116.004841
[33]
Mohan, V., Anoop, M., Bhansali, A., Singh, A.K., Makkar, B., Krishnan, D., et al. (2023) Role and Significance of Dietary Protein in the Management of Type 2 Diabetes and Its Complications in India: An Expert Opinion. Journal of the Association of Physicians of India, 71, 36-46.
[34]
Shai, I., Schwarzfuchs, D., Henkin, Y., Shahar, D.R., Witkow, S., Greenberg, I., et al. (2008) Weight Loss with a Low-Carbohydrate, Mediterranean, or Low-Fat Diet. New England Journal of Medicine, 359, 229-241. https://doi.org/10.1056/nejmoa0708681
[35]
Lattimer, J.M. and Haub, M.D. (2010) Effects of Dietary Fiber and Its Components on Metabolic Health. Nutrients, 2, 1266-1289. https://doi.org/10.3390/nu2121266
[36]
Kaviani, S. and Cooper, J.A. (2017) Appetite Responses to High-Fat Meals or Diets of Varying Fatty Acid Composition: A Comprehensive Review. European Journal of Clinical Nutrition, 71, 1154-1165. https://doi.org/10.1038/ejcn.2016.250
[37]
Thomsen, M.N., Skytte, M.J., Samkani, A., Carl, M.H., Weber, P., Astrup, A., et al. (2022) Dietary Carbohydrate Restriction Augments Weight Loss-Induced Improvements in Glycaemic Control and Liver Fat in Individuals with Type 2 Diabetes: A Randomised Controlled Trial. Diabetologia, 65, 506-517. https://doi.org/10.1007/s00125-021-05628-8
[38]
Birkeland, E., Gharagozlian, S., Birkeland, K.I., Valeur, J., Måge, I., Rud, I., et al. (2020) Prebiotic Effect of Inulin-Type Fructans on Faecal Microbiota and Short-Chain Fatty Acids in Type 2 Diabetes: A Randomised Controlled Trial. European Journal of Nutrition, 59, 3325-3338. https://doi.org/10.1007/s00394-020-02282-5
[39]
Singh, V., Lee, G., Son, H., Koh, H., Kim, E.S., Unno, T., et al. (2023) Butyrate Producers, “The Sentinel of Gut”: Their Intestinal Significance with and Beyond Butyrate, and Prospective Use as Microbial Therapeutics. Frontiers in Microbiology, 13, Article 1103836. https://doi.org/10.3389/fmicb.2022.1103836
[40]
Yoshida, H., Ishii, M. and Akagawa, M. (2019) Propionate Suppresses Hepatic Gluconeogenesis via GPR43/AMPK Signaling Pathway. Archives of Biochemistry and Biophysics, 672, Article 108057. https://doi.org/10.1016/j.abb.2019.07.022
[41]
Byrne, C.S., Chambers, E.S., Morrison, D.J. and Frost, G. (2015) The Role of Short Chain Fatty Acids in Appetite Regulation and Energy Homeostasis. International Journal of Obesity, 39, 1331-1338. https://doi.org/10.1038/ijo.2015.84
