A double blind, randomized, crossover, standard-controlled study to determine effect of Millet Flour+ GI-Ctrl on postprandial glucose level

Type 2 diabetes is becoming increasingly prevalent worldwide, with a particularly high impact in India. This growing burden underscores the urgent need for cost-effective dietary strategies to manage postprandial blood glucose levels. While metformin remains effective in glycemic control, it often falls short for overweight and obese individuals who face heightened risks of cardiovascular and microvascular complications. Although low glycemic index (GI) diets form a cornerstone of diabetes management, many traditional wheat-based foods still cause significant glucose spikes.

Millets, known for their naturally low GI and high fiber content, present a promising alternative for managing glycemic response. However, their efficacy can vary depending on preparation methods and individual metabolic differences. This study explores a novel food formulation that combines millet flour with glycemic index-lowering agents (GI-Ctrl) to enhance postprandial glucose control in high-risk populations.

Postprandial glucose responses are assessed using incremental area under the curve (iAUC), a reliable indicator that captures both the magnitude and duration of glucose elevation. The test formulation—millet flour enhanced with GI-Ctrl agents such as resistant starch and soluble fibers—is designed to slow carbohydrate digestion and absorption, thereby improving glycemic response compared to standard millet flour.

To evaluate the physiological impact of this intervention, additional markers such as maximum glucose concentration (Cmax) and time to reach this peak (Tmax) are analyzed. These parameters offer deeper insights into glucose metabolism and its regulation.The study targets individuals with diabetes, particularly those who are overweight or obese, due to their increased risk of dysglycemia. These individuals typically exhibit exaggerated postprandial glucose spikes and slower glucose clearance, contributing to insulin resistance and impaired beta cell function. A double-blind, randomized crossover design is employed to ensure robust and unbiased results, accounting for inter-individual variability. Real-time glucose monitoring through continuous glucose monitors (CGMs) allows for precise measurement of glycemic fluctuations following test and control product consumption.

In addition to glycemic outcomes, the study evaluates the safety and tolerability of the GI-Ctrl-enhanced formulation, as certain components may affect gastrointestinal health in some individuals. Ultimately, this research aims to provide evidence supporting the integration of Millet Flour + GI-Ctrl into dietary guidelines for diabetes management. The goal is to bridge traditional dietary habits with modern nutritional science, delivering a culturally relevant and scientifically validated solution for improving glycemic control in vulnerable populations.