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Not yet recruitingNCT07205705Updated Oct 3, 2025

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pre Diabetes

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03

In context

Glucose Intolerance

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.

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Lead sponsor

Diabetes Foundation, India is the lead sponsor of 30 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
140 participants (estimated)

Study arms

  • No intervention
    Control Group

    Wheat

  • Experimental
    Intervention Group

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

    Dietary Supplement: Millet

Interventions

  • Dietary supplementMillet

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

06

What researchers measure

Primary outcomes

  1. HbA1c (%)

    Time frame: 3 months

Secondary outcomes

  1. fasting glucose mg/dL) and satiety

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Sep 10, 2025
First posted
Oct 3, 2025
StartEst.
Nov 15, 2025
Primary completionEst.
Sep 15, 2027
CompletionEst.
Nov 20, 2027
Last update
Oct 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07205705
Lead sponsor
Diabetes Foundation, India
Responsible party
Sponsor
First posted
Oct 3, 2025
Start date
Nov 15, 2025 (estimated)
Primary completion
Sep 15, 2027 (estimated)
Completion
Nov 20, 2027 (estimated)
Last update
Oct 3, 2025

Study contacts

Anoop Misra, M.D.
Contact
anoopmisra@gmail.co
011-49101222

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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