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

August 11, 2026 updated by: Diabetes Foundation, India

Effect of CSIR-Developed High-Protein, Low-Glycaemic Index Rice on Glycaemic Response in Individuals With Prediabetes: An Acute and Subacute Crossover Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110016
        • National Diabetes, Obesity and Cholesterol Foundation (N-DOC)
        • Contact:
          • Phone Number: 01141759672

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Group
CSIR-Developed High-Protein, Low-Glycaemic Index Rice
Dietary supplement: Intervention Group
High-Protein, Low-Glycaemic Index Rice
Other Names:
  • CSIR-Developed High-Protein, Low-Glycaemic Index Rice
Active Comparator: Control Group
Conventional Rice
Dietary supplement: Intervention Group
High-Protein, Low-Glycaemic Index Rice
Other Names:
  • CSIR-Developed High-Protein, Low-Glycaemic Index Rice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Phase 1: Meal Tolerance Test
Time Frame: 1 day
incremental area under the curve(mg/dL)
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
meal tolerance study
Time Frame: 1 day
• Postprandial insulin response (pmol/L)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diabetes Foundation, India

Collaborators

National Diabetes, Obesity and Cholesterol Foundation (N-DOC)
CSIR National Institute for Interdisciplinary Science and Technology (NIIST), Thiruvananthapuram

Investigators

  • Principal Investigator: Anoop Misra, M.D., National Diabetes, Obesity and Cholesterol Foundation (N-DOC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 11, 2026

First Posted (Actual)

August 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NDOC/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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