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NCT Number: NCT07762768

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

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Diabetes, Obesity and Cholesterol Foundation (N-DOC)

New Delhi, National Capital Territory of Delhi, 110016, India

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Intervention Group

Dietary Supplement

High-Protein, Low-Glycaemic Index Rice

Other names: CSIR-Developed High-Protein, Low-Glycaemic Index Rice

Primary outcomes

  1. Study Phase 1: Meal Tolerance Test

    Time frame: 1 day

    incremental area under the curve(mg/dL)

Secondary outcomes

  1. meal tolerance study

    Time frame: 1 day

    • Postprandial insulin response (pmol/L)

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Diabetes Foundation, India

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

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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