Abstract
Background Type 2 diabetes mellitus (T2DM) is a chronic, non-communicable condition that causes insulin resistance and β-cell malfunction over time. The traditional food scene in India has changed dramatically as a result of rising urbanization and increased consumption of processed, Westernized diets heavy in refined carbs, saturated fats, and added sugars. These dietary changes have greatly contributed to the increased prevalence of type 2 diabetes. Medical nutrition therapy (MNT) is a systematic approach to nutrition management that aims to improve metabolic regulation and treatment results. MNT is often provided by a registered dietitian in collaboration with a diabetologist, and it focuses on personalized, evidence-based dietary guidelines. In this regard, NutroActive Industries Pvt. Ltd., India, has created a diabetic low glycemic load (GL) food product. The product kit contains Diabexy flour, Diabexy sugar substitute drops, Diabexy almond cookies, and Diabexy coconut burfi. These products are intended to provide a structured, low-GL meal plan that may support glycemic management. Although their formulation is nutritionally appropriate, clinical data for its effectiveness and safety are sparse. This randomized pilot trial sought to explore the potential effects of these products in improving glycemic parameters, such as fasting plasma glucose (FPG), postprandial glucose (PPG), and glycated hemoglobin (HbA1c), as well as their tolerance and safety. Method A total of 30 individuals with type 2 diabetes were randomly assigned to control and intervention groups. Baseline characteristics, including age, vital signs, and anthropometric parameters, were comparable between groups (p > 0.03), indicating adequate randomization. Ten participants demonstrated significantly lower postprandial glucose responses to Diabexy atta compared with glucose (iAUC: 52 vs. 241 mmol·min/L), corresponding to a low glycemic index (GI) of 22%. In the intervention group, the low-GL kit was associated with stable HbA1c, changes in fasting insulin that were interpreted alongside HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) to assess insulin dynamics, and improved quality-of-life scores. Safety assessments showed no adverse effects on liver, kidney, or lipid parameters. Indigestion was reported in one participant during the study period; however, it was transient and not considered related to the low-GL intervention kit. Overall, these findings suggest a potential metabolic benefit of Diabexy atta as part of a low-GL dietary approach, within the limitations of this pilot study. Conclusion In this randomized, open-label pilot study, the low-GL dietary intervention was associated with reductions in postprandial glucose levels, stabilization of HbA1c, and improvements in insulin resistance compared with standard care. No clinically significant safety concerns were observed over the study period based on clinical and laboratory assessments. While these findings suggest a potential metabolic benefit of the low-GL approach in individuals with T2DM, they should be interpreted cautiously given the small sample size, short duration, and exploratory nature of the study. Larger, well-controlled trials are warranted to confirm these preliminary observations.