Effect of CSIR-Developed High-Protein, Low-Glycaemic Index Rice on Glycaemic Response in Individuals With Prediabetes: An Acute and Subacute Crossover Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Diabetes Foundation, India
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Study Phase 1: Meal Tolerance Test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention Group
CSIR-Developed High-Protein, Low-Glycaemic Index Rice
Intervention: Intervention Group (Dietary Supplement)
Control Group
Conventional Rice
Intervention: Intervention Group (Dietary Supplement)
Outcomes
Primary Outcomes
Study Phase 1: Meal Tolerance Test
Time Frame: 1 day
incremental area under the curve(mg/dL)
Secondary Outcomes
- meal tolerance study(1 day)