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NCT Number: NCT07205705

Impact of Partially Replacing Wheat With Millets or Bengal Gram Flour in Rotis on Glycemia and Prediabetes Reversal

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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
  • Subjects with uncontrolled hypothyroidism or hypertension
  • On any drug causing weight gain or weight loss

Treatment and study plan

Millet

Dietary Supplement

Wheat + Barnyard millet/ Wheat +Barley/ wheat+ Bengal gram flour

Primary outcomes

  1. HbA1c (%)

    Time frame: 3 months

Secondary outcomes

  1. fasting glucose mg/dL) and satiety

    Time frame: 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Anoop Misra, M.D.

CONTACT

[email protected]

011-49101222

Sponsors and collaborators

Lead sponsor

Diabetes Foundation, India

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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