Effect of Proso Millet-Based Bread on Postprandial Glycemic Response in Adults With Type 2 Diabetes

Overview

This randomized, double-blind, crossover clinical study aims to evaluate the acute effect of proso millet-based bread on postprandial glycemic response in adults with type 2 diabetes. A total of 52 participants are planned to be enrolled. Each participant will attend two test sessions and will consume proso millet-based bread in one session and white wheat bread in the other. The order of the test breads will be randomized, and the two sessions will be separated by a one-week washout period. Each bread portion will provide 50 g of available carbohydrate. During each test session, the bread will be consumed within 10 minutes with 250 mL of water. Capillary blood glucose concentrations will be measured at predefined time points from baseline to 180 minutes after the start of consumption. Postprandial glycemic response will primarily be evaluated using the incremental area under the glucose response curve (iAUC). The study will investigate whether the postprandial glycemic response following consumption of proso millet-based bread differs from that following consumption of white wheat bread in adults with type 2 diabetes.

This is a randomized, double-blind, two-period crossover clinical study designed to evaluate the acute postprandial glycemic response to proso millet-based bread compared with white wheat bread in adults with type 2 diabetes. Prior to the clinical phase, different proso millet-based bread formulations will be evaluated for sensory and physical characteristics. The formulation with the highest overall acceptability and appropriate structural characteristics will be selected as the investigational bread for the clinical phase. Texture profile analysis will be performed for quality-control purposes on the selected proso millet-based bread and the white wheat bread. In the clinical phase, participants will undergo two test sessions in randomized order. Each participant will receive both interventions and therefore serve as their own control. The two sessions will be separated by a one-week washout period. The investigational intervention will consist of the selected proso millet-based bread, and the comparator intervention will consist of white wheat bread. Portions will be standardized to provide 50 g of available carbohydrate, calculated as total carbohydrate minus dietary fiber. Test products will be presented using coded identifiers to maintain blinding of participants and investigators. At each test session, participants will consume the assigned bread within 10 minutes together with 250 mL of water. Timing will begin with the first bite. Capillary blood glucose will be measured at 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes. Postprandial glucose response will be evaluated using the incremental area under the glucose response curve calculated by the trapezoidal method. Before the test sessions, participant characteristics, health information, dietary habits, physical activity, dietary intake, anthropometric measurements, and body composition will be assessed. These data will be used to characterize the study population and support the evaluation of the clinical findings.