About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age 18-60 years
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
Disqualifiers
Diagnosed diabetes mellitus
Acute infections or any debilitating illness
History of hepatic, pancreatic, renal, or cardiovascular disease
Abnormal liver or renal function tests
Trial design
Crossover
Treatments tested in this trial
Intervention Group
Dietary supplementHigh-Protein, Low-Glycaemic Index Rice
Treatment groups
Trial outcomes
Primary outcomes
Study Phase 1: Meal Tolerance Test
incremental area under the curve(mg/dL)
Secondary outcomes
meal tolerance study
• Postprandial insulin response (pmol/L)
Sponsors and contacts
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Diabetes Foundation, India
Lead sponsor
National Diabetes, Obesity and Cholesterol Foundation (N-DOC)
Collaborator
CSIR National Institute for Interdisciplinary Science and Technology (NIIST), Thiruvananthapuram
Collaborator
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