About this trial
There is limited research on the impact of millets on glycemia, and it remains unclear whether partially replacing wheat in rotis with low glycemic index millets or Bengal gram flour offers greater glycemic benefits compared to whole wheat. This approach has the potential to reduce postprandial and overall glycemia, supporting the reversal of prediabetes through dietary modification alone. This study introduces a novel formulation of rotis using 50:50 blends of wheat with either barnyard millet, barley, or Bengal gram flour, aiming to improve glycemic control without compromising taste. Glycemic response is assessed through a combination of meal tolerance tests, continuous glucose monitoring, and a three-month dietary intervention, providing both immediate and long-term data. Additionally, the study includes a comprehensive metabolic evaluation by measuring serum insulin, inflammatory markers, and free fatty acids key indicators in the progression of prediabetes. Conducted as a randomized controlled trial with 80 participants across four arms (20 per arm), the study comprises three phases: Phase I evaluates immediate glycemic response through a meal tolerance test; Phase II uses continuous glucose monitoring over three days to monitor fluctuations in glucose levels; and Phase III, with 140 participants, assesses the long-term impact of the dietary intervention over three months. The primary objectives are to determine the effect of the interventions on glycemic response and HbA1c, with an expected outcome of a 10% reduction in the area under the curve for overall and postprandial glucose in Phases I and II, and a 10% reduction in HbA1c in Phase III.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 60 years
Prediabetes as diagnosed on oral glucose tolerance test (OGTT): Fasting blood glucose ≥100mg/dl and <126 mg/dl and/or 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75 gram anhydrous oral glucose).
Disqualifiers
Acute infections and advanced end-organ damage
History of hepatitis or pancreatitis, abnormal liver and renal functions
Recent (<3 months) changes in weight (≥5%) and/or weight-changing medications
Any known allergy to wheat or any other grain
Trial design
Parallel
Treatments tested in this trial
Millet
Dietary supplementWheat + Barnyard millet/ Wheat +Barley/ wheat+ Bengal gram flour
Treatment groups
Trial outcomes
Primary outcomes
HbA1c (%)
Secondary outcomes
fasting glucose mg/dL) and satiety
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: