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.
Age between 35 and 60 years Body mass index (BMI) ≥18.5 and ≤39.99 kg/m² Diagnosed with type 2 diabetes mellitus for at least 1 year Stable doses of antidiabetic medications for at least 3 months Cognitively capable of following dietary records and study instructions
Presence of atherosclerotic cardiovascular disease Malignancy Gastrointestinal disease Psychiatric disease Use of vitamin, mineral, or nutritional supplements Food allergy Following a weight-loss diet within the previous 3 months Regular consumption of millet (proso millet) Use of medications affecting carbohydrate metabolism Insulin therapy History of alcohol or substance dependence Major surgery within the previous 6 months Thyroid disease, including hypothyroidism or hyperthyroidism Engagement in high-intensity physical activity (e.g., professional athletes) Habitual consumption of a high-fiber diet Sleep disorder or night-shift work Antibiotic treatment Blood transfusion within the previous 3 months Presence of other endocrine disorders that may affect glucose metabolism Inability or unwillingness to comply with the study protocol Fasting capillary blood glucose at 0 minutes <70 mg/dL or >150 mg/dL, or HbA1c >7.5% Heavy exercise within the previous 48 hours Current infection Smoking or alcohol consumption before the test session Caffeine consumption within the previous 24 hours Acute stress Use of medications that may affect blood glucose, such as corticosteroids or beta-blockers
Crossover
Proso Millet-Based Bread
Other interventionParticipants will consume a portion of proso millet-based bread providing 50 g of available carbohydrate (total carbohydrate minus dietary fiber) within 10 minutes, accompanied by 250 mL of water.
White Wheat Bread
Other interventionParticipants will consume a portion of white wheat bread providing 50 g of available carbohydrate (total carbohydrate minus dietary fiber) within 10 minutes, accompanied by 250 mL of water.
Incremental Area Under the Curve (iAUC) for Postprandial Blood Glucose
The incremental area under the curve (iAUC) for capillary blood glucose will be calculated using the trapezoidal method based on glucose concentrations measured at 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes after consumption of each test bread. The iAUC will be compared between the proso millet-based bread and white wheat bread interventions.
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Gazi University
Lead sponsor
The Scientific and Technological Research Council of Turkey
Collaborator
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