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

ConditionPrediabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorDiabetes Foundation, India

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Intervention Group

    Dietary supplement

    High-Protein, Low-Glycaemic Index Rice

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Intervention GroupActive comparator 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Study Phase 1: Meal Tolerance Test

incremental area under the curve(mg/dL)

Time frame
1 day

Secondary outcomes

1

meal tolerance study

• Postprandial insulin response (pmol/L)

Time frame
1 day

Other outcomes

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

This trial is not recruiting at the moment. You can still explore other options: