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

NCT07762768 · tracked via the Priya Life Science India tracker

Sponsor

Diabetes Foundation, India

Phase

Not applicable

Started

2026-09-01

Last updated

2026-08-13

Condition(s) studied

Prediabetes

Investigational drug(s) / intervention(s)

Intervention Group

Intervention Group: High-Protein, Low-Glycaemic Index Rice

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

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

Primary outcome measure(s)

Study Phase 1: Meal Tolerance Test — 1 day
incremental area under the curve(mg/dL)

Trial sites (1)

Facility	City	Region	Status
National Diabetes, Obesity and Cholesterol Foundation (N-DOC)	New Delhi	National Capital Territory of Delhi

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07762768 on ClinicalTrials.gov ↗ ← All trials in India