PrediabetesNCT07762768
Effect of CSIR-Developed High-Protein, Low-Glycaemic Index Rice on Glycaemic Response in Individuals With Prediabetes
A study testing Intervention Group in people with Prediabetes, run by Diabetes Foundation, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy or lactation
- Known allergy or intolerance to study foods
- Any condition that, in the investigator's opinion, may interfere with study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
National Diabetes, Obesity and Cholesterol Foundation (N-DOC)
New Delhi, National Capital Territory of Delhi, 110016
01141759672
About this study
Official title: Effect of CSIR-Developed High-Protein, Low-Glycaemic Index Rice on Glycaemic Response in Individuals With Prediabetes: An Acute and Subacute Crossover Study
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.
- Conditions
- Prediabetes
- Being tested
- Intervention Group
- Keywords
- High-Protein, Low-Glycaemic Index Rice, Conventional Rice, Prediabetes
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupDietary supplement
Also called CSIR-Developed High-Protein, Low-Glycaemic Index Rice
High-Protein, Low-Glycaemic Index Rice
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | CSIR-Developed High-Protein, Low-Glycaemic Index Rice Receives: Dietary Supplement: Intervention Group |
| Control Group | Active comparator | Conventional Rice Receives: Dietary Supplement: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Phase 1: Meal Tolerance Test
incremental area under the curve(mg/dL)
Measured: 1 day
Secondary outcomes (1)
meal tolerance study
- Postprandial insulin response (pmol/L)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- National Diabetes, Obesity and Cholesterol Foundation (N-DOC), CSIR National Institute for Interdisciplinary Science and Technology (NIIST), Thiruvananthapuram
- Responsible party
- Sponsor
- Investigators
- Anoop Misra, M.D., Principal investigator, National Diabetes, Obesity and Cholesterol Foundation (N-DOC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762768
- Sponsor's protocol ID
- NDOC/2026
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CSIR-Developed High-Protein, Low-Glycaemic Index Rice on Glycaemic Response in Individuals With Prediabetes: An Acute and Subacute Crossover Study
- ClinicalTrials.gov ID
- NCT07762768
- Acronym / sponsor ID
- NDOC/2026
- Conditions
- Prediabetes
- Keywords
- High-Protein, Low-Glycaemic Index Rice, Conventional Rice, Prediabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Collaborators
- National Diabetes, Obesity and Cholesterol Foundation (N-DOC), CSIR National Institute for Interdisciplinary Science and Technology (NIIST), Thiruvananthapuram
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Dietary Supplement: Intervention GroupCSIR-Developed High-Protein, Low-Glycaemic Index Rice |
| Control Group | Active comparator | Dietary Supplement: Intervention GroupConventional Rice |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-60 years
- Individuals with prediabetes, defined by oral glucose tolerance test (OGTT) as:
- Willingness to participate and comply with study procedures
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupAlso: CSIR-Developed High-Protein, Low-Glycaemic Index RiceHigh-Protein, Low-Glycaemic Index Rice | Dietary supplement | Control Group, Intervention Group |
Primary outcome
Study Phase 1: Meal Tolerance Test
Time frame: 1 day
incremental area under the curve(mg/dL)
1 secondary outcome
meal tolerance study
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anoop Misra, M.D. principal investigator
National Diabetes, Obesity and Cholesterol Foundation (N-DOC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Prediabetes, run by Diabetes Foundation, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anoop Misra, M.D. (011-41759672 ext. 103, anoopmisra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Phase 1: Meal Tolerance Test (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.