Effect of CSIR-Developed High-Protein, Low-Glycaemic Index Rice on Glycaemic Response in Individu… (NCT07762768) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of CSIR-Developed High-Protein, Low-Glycaemic Index Rice on Glycaemic Response in Individuals With Prediabetes
India36 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.