Effect of CSIR-Developed High-Protein, Low-Glycaemic Index Rice on Glycaemic Response in Individuals With Prediabetes
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2026
CompletedFirst Posted
Study publicly available on registry
August 13, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2027
Study Completion
Last participant's last visit for all outcomes
February 28, 2027
August 13, 2026
August 1, 2026
6 months
August 5, 2026
August 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Study Phase 1: Meal Tolerance Test
incremental area under the curve(mg/dL)
1 day
Secondary Outcomes (1)
meal tolerance study
1 day
Study Arms (2)
Intervention Group
ACTIVE COMPARATORCSIR-Developed High-Protein, Low-Glycaemic Index Rice
Control Group
ACTIVE COMPARATORConventional Rice
Interventions
High-Protein, Low-Glycaemic Index Rice
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Diabetes, Obesity and Cholesterol Foundation (N-DOC)
New Delhi, National Capital Territory of Delhi, 110016, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anoop Misra, M.D.
National Diabetes, Obesity and Cholesterol Foundation (N-DOC)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2026
First Posted
August 13, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
February 15, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
August 13, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share