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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07762768

Enrollment

Registered

2026-08-13

Start date

2026-09-01

Completion date

2027-02-28

Last updated

2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes

Keywords

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

Brief 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.

Interventions

DIETARY_SUPPLEMENTIntervention Group

High-Protein, Low-Glycaemic Index Rice

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 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

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

CONTACTAnoop Misra, M.D.

anoopmisra@gmail.com011-41759672

CONTACTSeema Gulati, Ph.d

seemagulati2007@gmail.com011-41759672

PRINCIPAL_INVESTIGATORAnoop Misra, M.D.

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026