ClinicalTrials.gg
Not yet recruitingNCT07762768Updated Aug 13, 2026

Effect of CSIR-Developed High-Protein, Low-Glycaemic Index Rice on Glycaemic Response in Individuals With Prediabetes

An interventional study of Intervention Group in Prediabetes, sponsored by Diabetes Foundation, India. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Diabetes Foundation, India · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This is a randomized, controlled, two-phase crossover study will be conducted in adults aged 18-60 years with prediabetes to compare the effects of a CSIR-developed high-protein, low-glycaemic index rice with conventional rice. Phase I will evaluate acute postprandial glucose, insulin, C-peptide, GLP-1, and hunger/satiety responses, while Phase II will assess 72-hour continuous glucose monitoring (CGM) outcomes, including mean glucose and glycaemic variability. Eligible participants will be randomly assigned to receive both rice types in a crossover manner, with each participant serving as their own control. Individuals with diabetes, major systemic illnesses, abnormal liver or renal function, pregnancy, or glucose-lowering medication use will be excluded.

02

Conditions studied

  • Prediabetes

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Keywords

  • High-Protein, Low-Glycaemic Index Rice
  • Conventional Rice
  • Prediabetes
03

In context

Prediabetic State

918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.

This study's planned enrollment of 36 is below the median of 62 across 762 interventional studies indexed under Prediabetic State.

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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

  • Age 18-60 years
  • Individuals with prediabetes, defined by oral glucose tolerance test (OGTT) as:

    • Fasting plasma glucose ≥100 mg/dL and \<126 mg/dL, and/or
    • 2-hour plasma glucose ≥140 mg/dL and \<200 mg/dL following ingestion of 75 g anhydrous glucose
  • Willingness to participate and comply with study procedures

Exclusion criteria

Exclusion Criteria:

  • Diagnosed diabetes mellitus
  • Acute infections or any debilitating illness
  • History of hepatic, pancreatic, renal, or cardiovascular disease
  • Abnormal liver or renal function tests
  • Recent (\<3 months) weight change ≥5% or use of weight-altering medications
  • Use of glucose-lowering medications
  • Pregnancy or lactation
  • Known allergy or intolerance to study foods
  • Any condition that, in the investigator's opinion, may interfere with study participation
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Active comparator
    Intervention Group

    CSIR-Developed High-Protein, Low-Glycaemic Index Rice

    Dietary Supplement: Intervention Group

  • Active comparator
    Control Group

    Conventional Rice

    Dietary Supplement: Intervention Group

Interventions

  • Dietary supplementIntervention Group

    High-Protein, Low-Glycaemic Index Rice

    Also known as: CSIR-Developed High-Protein, Low-Glycaemic Index Rice

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What researchers measure

Primary outcomes

  1. Study Phase 1: Meal Tolerance Test

    incremental area under the curve(mg/dL)

    Time frame: 1 day

Secondary outcomes

  1. meal tolerance study

    • Postprandial insulin response (pmol/L)

    Time frame: 1 day

07

Study locations

1 site
  • National Diabetes, Obesity and Cholesterol Foundation (N-DOC)
    New Delhi, National Capital Territory of Delhi 110016, India
    • · Contact01141759672
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07762768
Lead sponsor
Diabetes Foundation, India
Collaborators
National Diabetes, Obesity and Cholesterol Foundation (N-DOC), CSIR National Institute for Interdisciplinary Science and Technology (NIIST), Thiruvananthapuram
Responsible party
Sponsor
First posted
Aug 13, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Feb 15, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Aug 13, 2026

Study contacts

Anoop Misra, M.D.
Contact
anoopmisra@gmail.com
011-41759672 ext. 103
Seema Gulati, Ph.d
Contact
seemagulati2007@gmail.com
011-41759672 ext. 102
Anoop Misra, M.D.
principal investigator · National Diabetes, Obesity and Cholesterol Foundation (N-DOC)

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 Aug 2026. You cannot join it, but the record below documents what was studied.

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