An interventional study of Millet in Pre Diabetes, sponsored by Diabetes Foundation, India. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Diabetes Foundation, India · Not applicable, Interventional, and Prevention
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.
793 studies on the registry are indexed under Glucose Intolerance; 115 are open to participants now.
This study's planned enrollment of 140 is above the median of 56 across 661 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →Diabetes Foundation, India is the lead sponsor of 30 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Wheat
Wheat + Barnyard millet/ Wheat +Barley/ wheat+ Bengal gram flour
Dietary Supplement: Millet
Wheat + Barnyard millet/ Wheat +Barley/ wheat+ Bengal gram flour
HbA1c (%)
Time frame: 3 months
fasting glucose mg/dL) and satiety
Time frame: 3 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2025; primary completion for Sep 2027, 22 months later.
Of 254 non-industry interventional studies with no phase under Glucose Intolerance, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 22 months is below that.
Counting every sponsor, half of 286 studies reached it within 26 months; a quarter within 10 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Diabetes Foundation, India