Clinical Evaluation of a Patent-Pending Plant-Based Dietary Test Formulation, No-SugarX® (NSX), in the Prevention and Management of Type 2 Diabetes Mellitus: A Six-Month Controlled Human Study

International Journal of Medical Science

© 2026 by SSRG - IJMS Journal

Volume 12 Issue 6

Year of Publication : 2026

Authors : Shafi M. Shaafi, Harish Kulkarni, Khamer Taj

10.14445/23939117/IJMS-V12I6P103

How to Cite?

Shafi M. Shaafi, Harish Kulkarni, Khamer Taj, "Clinical Evaluation of a Patent-Pending Plant-Based Dietary Test Formulation, No-SugarX® (NSX), in the Prevention and Management of Type 2 Diabetes Mellitus: A Six-Month Controlled Human Study," SSRG International Journal of Medical Science, vol. 12,  no. 6, pp. 23-26, 2026. Crossref, https://doi.org/10.14445/23939117/IJMS-V12I6P103

Abstract:

The rapidly rising global menace called Type 2 Diabetes Mellitus (T2DM) is largely driven by changes in lifestyle and dietary habits. Although drug-based strategies are effective to date, the control and management of T2DM are challenged with side effects and costs, along with diminished patient compliance. In fact, some plant-based nutrition modalities have shown improved glycemic control; however, there is a paucity of reports on their efficacy in controlled human studies using a standardized plant-based modality. The aim is to test the preventive and therapeutic properties of a plant-based modality – a patented formulation called No-SugarX®-NSX- in non-diabetic and drug-naïve type 2 diabetic subjects compared with traditional drug modalities. In a randomized controlled four-armed parallel human study with 200 forty- to sixty-year-old participants in Kerala and Karnataka states in Southern India over a six-month period. The primary outcome parameters included Fasting Blood Glucose (FBG), Post-Prandial Glucose (PPG), and glycated hemoglobin (HbA1c) levels. NSX significantly lowered FBG (20 to 35%), PPG (18 to 30%), and HbA1c (1.8 to 1.2%), a similar effect to drug regimens in drug-naïve T2DM subjects. Some modest preventive metabolic modulations occurred in non-diabetic subjects. There are no adverse effects.

Keywords:

Glycaemic control, HbA1c, Low glycaemic index, Plant-based nutrition, Type 2 Diabetes Mellitus, Drug therapy, No-SugarX™.

References:

[1] American Diabetes Association, “Summary of Revisions: Standards of Medical Care in Diabetes-2024,” Diabetes Care, vol. 47, suppl. 1, pp. S5-S10, 2024.
[CrossRef] [Google Scholar] [Publisher Link]
[2] Dianna Magliano, and Edward J. Boyko, IDF Diabetes Atlas, International Diabetes Federation, 2021.
[Google Scholar] [Publisher Link]
[3] Frank B. Hu, “Globalization of Diabetes: The Role of Diet, Lifestyle, and Genes,” Diabetes Care, vol. 34, no. 6, pp. 1249-1257, 2011.
[CrossRef] [Google Scholar] [Publisher Link]
[4] Neal D. Barnard et al., “A Low-Fat Vegan Diet Improves Glycemic Control and Cardiovascular Risk Factors in a Randomized Clinical Trial in Individuals with Type 2 Diabetes,” Diabetes Care, vol. 29, no. 8, pp. 1777-1783, 2006.
[CrossRef] [Google Scholar] [Publisher Link]
[5] Ambika Satija et al., “Plant-Based Dietary Patterns and Incidence of Type 2 Diabetes in US Men and Women: Results from Three Prospective Cohort Studies,” PLoS Medicine, vol. 13, no. 6, 2016.
[CrossRef] [Google Scholar] [Publisher Link]
[6] Sylvia H. Ley et al., “Prevention and Management of type 2 Diabetes: Dietary Components and Nutritional Strategies,” The Lancet, vol. 383, no. 9933, pp. 1999-2007, 2014.
[Google Scholar] [Publisher Link]
[7] Katherine Esposito et al., “Prevention and Control of Type 2 Diabetes by Mediterranean Diet: A Systematic Review,” Diabetes Research and Clinical Practice, vol. 89, no. 2, pp. 97-102, 2010.
[CrossRef] [Google Scholar] [Publisher Link]
[8] Olubukola Ajala, Patrick English, and Jonathan Pinkney, “Systematic Review and Meta-analysis of Different Dietary Approaches to the Management of type 2 Diabetes,” The American Journal of Clinical Nutrition, vol. 97, no. 3, pp. 505-516, 2013.
[CrossRef] [Google Scholar] [Publisher Link]
[9] David J.A. Jenkins et al., “Effect of Legumes as Part of a Low Glycemic Index Diet on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes Mellitus A Randomized Controlled Trial,” Archives of Internal Medicine, vol. 172, no. 21, pp. 1653-1660, 2012.
[CrossRef] [Google Scholar] [Publisher Link]
[10] Shilpa N. Bhupathiraju et al., “Glycemic Index, Glycemic Load, and Risk of Type 2 Diabetes: Results from 3 Large US Cohorts and An Updated Meta-analysis,” American Journal of Clinical Nutrition, vol. 100, no. 1, pp. 218-232, 2014.
[CrossRef] [Google Scholar] [Publisher Link]
[11] Omorogieva Ojo, “Dietary Intake and Type 2 Diabetes,” Nutrients, vol. 11, no. 9, 2019.
[CrossRef] [Google Scholar] [Publisher Link]
[12] David S. Ludwig, “The Glycemic Index,” Journal of the American Medical Association, vol. 287, no. 18, pp. 2414-2423, 2002.
[CrossRef] [Google Scholar] [Publisher Link]
[13] Jordi Salas-Salvadó et al., “Reduction in the Incidence of Type 2 Diabetes with the Mediterranean Diet: Results of the Predimed Reus Nutrition Intervention Randomized Trial,” Diabetes Care, vol. 34, no. 1, pp. 14-19, 2011.
[CrossRef] [Google Scholar] [Publisher Link]
[14] Lukas Schwingshackl, and Georg Hoffmann, “Long-term Effects of Low-fat Diets Either Low or High in Protein on Cardiovascular and Metabolic Risk Factors: A Systematic Review and Meta-Analysis,” Nutrition Journal, vol. 12, pp. 1-9, 2013.
[CrossRef] [Google Scholar] [Publisher Link]
[15] Gabriele Riccardi, Angela A. Rivellese, and Rosalba Giacco, “Role of Glycemic Index and Glycemic Load in the Healthy State, in Prediabetes, and in Diabetes,” The American Journal of Clinical Nutrition, vol. 87, no. 1, pp. 269S-274S, 2008.
[CrossRef] [Google Scholar] [Publisher Link]
[16] Martin O. Weickert, and Andreas F.H. Pfeiffer, “Metabolic Effects of Dietary Fiber Consumption and Prevention of Diabetes,” The Journal of Nutrition, vol. 138, no. 3, pp. 439-442, 2008.
[Google Scholar] [Publisher Link]
[17] Jordi Salas-Salvadó et al., “Nuts in the Prevention and Treatment of Metabolic Syndrome,” The American Journal of Clinical Nutrition, vol. 100, pp. 399S-407S, 2014.
[CrossRef] [Google Scholar] [Publisher Link]
[18] D.J.A. Jenkins et al., “Low-glycemic Index Diet in Diabetes,” Journal of Nutrition, vol. 132, pp. 2072-2079, 2002.
[19] Pan An et al., “Red Meat Consumption and Risk of Type 2 Diabetes: 3 Cohorts of US Adults and An Updated Meta-Analysis,” American Journal of Clinical Nutrition, vol. 94, no. 4, pp. 1088-1096, 2011.
[CrossRef] [Google Scholar] [Publisher Link]
[20] Diana Thomas, and Elizabeth J. Elliott, “Low Glycaemic Index, or Low Glycaemic Load, Diets for Diabetes Mellitus,” Cochrane Database of Systematic Reviews, 2009.
[CrossRef] [Google Scholar] [Publisher Link]
[21] Lukas Schwingshackl et al., “Plant-based Dietary Patterns and Glycaemic Control,” European Journal of Epidemiology, vol. 33, pp. 157-170, 2018.
[CrossRef] [Google Scholar] [Publisher Link]
[22] James W. Anderson et al., “Health Benefits of Dietary Fiber,” Nutrition Reviews, vol. 67, no. 4, pp. 188-205, 2009.
[CrossRef] [Google Scholar] [Publisher Link]
[23] Frank M. Sacks et al., “Comparison of Weight-loss Diets with Different Compositions of Fat, Protein, and Carbohydrates,” The New England Journal of Medicine, vol. 360, pp. 859-873, 2009.
[CrossRef] [Google Scholar] [Publisher Link]
[24] Joanne L. Slavin, “Dietary Fiber and Body Weight,” Nutrition, vol. 21, no. 3, pp. 411-418, 2005.
[CrossRef] [Google Scholar] [Publisher Link]
[25] Kitt Falk Petersen et al., “Impaired Mitochondrial Activity in the Insulin-Resistant Offspring of Patients with Type 2 Diabetes,” The New England Journal of Medicine, vol. 350, no. 7, pp. 664-671, 2004.
[CrossRef] [Google Scholar] [Publisher Link]
[26] Hana Kahleová, and Terezie Pelikánová, “Vegetarian Diets in the Prevention and Treatment of type 2 Diabetes,” Journal of the American College of Nutrition, vol. 34, pp. 448-458, 2015.
[CrossRef] [Google Scholar] [Publisher Link] 
[27] David J.A. Jenkins et al., “Effect of a Low–Glycemic Index or a High–Cereal Fiber Diet on Type 2 Diabetes,” Journal of the American Medical Association, vol. 300, no. 23, pp. 2742-2753, 2008.
[CrossRef] [Google Scholar] [Publisher Link]
[28] Andrew Reynolds et al., “Carbohydrate Quality and Human Health: A Series of Systematic Reviews and Meta-Analyses,” The Lancet, vol. 393, no. 10170, pp. 434-445, 2019.
[Google Scholar] [Publisher Link]
[29] Dagfinn Aune et al., “Whole Grain and Refined Grain Consumption and The Risk of Type 2 Diabetes: A Systematic Review and Dose–Response Meta-analysis of Cohort Studies,” European Journal of Epidemiology, vol. 28, pp. 845-858, 2013.
[CrossRef] [Google Scholar] [Publisher Link]
[30] Sofi Francesco et al., “Accruing Evidence on Benefits of Adherence to the Mediterranean Diet on Health: An Updated Systematic Review and Meta-analysis,” The American Journal of Clinical Nutrition, vol. 92, no. 5, pp. 1189-1196, 2010.
[CrossRef] [Google Scholar] [Publisher Link]