Millet
Dietary SupplementWheat + Barnyard millet/ Wheat +Barley/ wheat+ Bengal gram flour
NCT Number: NCT07205705
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.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Wheat + Barnyard millet/ Wheat +Barley/ wheat+ Bengal gram flour
Time frame: 3 months
Time frame: 3 months
Contact information is provided by the study sponsor or research team.
Diabetes Foundation, India
Other
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