Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07205705
Enrollment
140
Registered
2025-10-03
Start date
2025-11-15
Completion date
2027-11-20
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre Diabetes

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTMillet

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

Sponsors

Diabetes Foundation, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18 to 60 years 2. 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

1. Acute infections and advanced end-organ damage 2. History of hepatitis or pancreatitis, abnormal liver and renal functions 3. Recent (\<3 months) changes in weight (≥5%) and/or weight-changing medications 4. Any known allergy to wheat or any other grain 5. Subjects with uncontrolled hypothyroidism or hypertension 6. On any drug causing weight gain or weight loss

Design outcomes

Primary

MeasureTime frame
HbA1c (%)3 months

Secondary

MeasureTime frame
fasting glucose mg/dL) and satiety3 months

Contacts

Primary ContactAnoop Misra, M.D.
anoopmisra@gmail.co011-49101222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026