| CTRI Number |
CTRI/2026/01/100485 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
A study in healthy adults to see how different foods affect blood sugar levels |
|
Scientific Title of Study
|
A Non Randomized, Open-Label, Crossover, Reference controlled clinical study to Evaluate the Glycemic Index (GI) of Food Products Compared with Glucose Reference in Healthy adults(ISO 26642 Methodology) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PHAR-GI-01 Version 01 Dated 12/12/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Mahesh |
| Designation |
Consultant |
| Affiliation |
Gita Clinic |
| Address |
Gita Clinic No 238 4th Cross 4th main Nelamaheshwaramma road Near Byalappa Circle Dasarahalli
Bangalore KARNATAKA 560057 India |
| Phone |
8105868530 |
| Fax |
|
| Email |
drpriyankamahesh1990@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Baburao Vikram |
| Designation |
Director |
| Affiliation |
Pharexcel Consulting Private Limited |
| Address |
15093, Tata New Haven, Seshagirirao Palya Village, Dasanpura Hobli, Near The Golden Palms Hotel & Spa Bengaluru North Taluka, Karnataka
Bangalore KARNATAKA 562123 India |
| Phone |
9878551428 |
| Fax |
|
| Email |
info@pharexcelconsulting.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prashanth Varkey |
| Designation |
Director |
| Affiliation |
Sugarcan Innovations Pvt Ltd |
| Address |
936, 203, 2nd Floor Vaishnavi Sapphire Centre,Yeswanthpura, Bangalore, Karnataka India 560022
Bangalore KARNATAKA 560022 India |
| Phone |
9249584682 |
| Fax |
|
| Email |
prashanth@sugarcaninnovations.com |
|
|
Source of Monetary or Material Support
|
| Sugarcan Innovations Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Sugarcan Innovations Pvt Ltd |
| Address |
936, 203, 2nd Floor Vaishnavi Sapphire Centre,Yeswanthpura, Bangalore, Karnataka India 560022 |
| Type of Sponsor |
Other [food/biotech company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Westleys Resto Cafe |
Metro Pillar 481, Ground Floor, Kaliyath Building, Palarivattom - Edappally Rd, opp. to ARC Fertility Clinic, Mamangalam, Kochi, Kerala 682025 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Mahesh |
Gita Clinic |
Gita Clinic No 238 4th 4th cross 4th main Nelamaheshwaramma Road Bylappa Circle Bangalore KARNATAKA |
8105868530
drpriyankamahesh1990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pharexcel Independent Ethics Committee Pharexcel Consulting Private Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bread |
test food Bread products containing 50 g of available carbohydrate |
| Intervention |
Carbonated drinks |
test food carbonated drinks products containing 50 g of available carbohydrate |
| Intervention |
Chapati |
test food Chapati products containing 50 g of available carbohydrate |
| Comparator Agent |
dextrose monohydrate |
55 g of dextrose monohydrate dissolved in approximately 250 mL of water |
| Intervention |
Gulab jamun |
test food Gulab jamun products containing 50 g of available carbohydrate |
| Intervention |
idly |
test food idly products containing 50 g of available carbohydrate |
| Intervention |
Jaggery |
test food jaggery product containing 50 g of available carbohydrate |
| Intervention |
Jalebi |
test food Jalebi products containing 50 g of available carbohydrate |
| Intervention |
Jam |
test food Jam products containing 50 g of available carbohydrate |
| Intervention |
Juice |
test food Juice products containing 50 g of available carbohydrate |
| Intervention |
Payasam |
test food Payasam products containing 50 g of available carbohydrate |
| Intervention |
Pedda |
test food Pedda products containing 50 g of available carbohydrate |
| Intervention |
Pudding |
test food pudding products containing 50 g of available carbohydrate |
| Intervention |
Rice |
test food Rice products containing 50 g of available carbohydrate |
| Intervention |
Sugar |
test food Sugar products containing 50 g of available carbohydrate |
| Intervention |
Wheat |
test food wheat products containing 50 g of available carbohydrate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.BMI 18.5 to 25 kg per m² (or as defined).
2.Fasting blood glucose within normal range.
3.Subjects with normal glucose tolerance
4.Willing to comply with study visits and procedures.
5.Willing to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1.History of diabetes, metabolic/endocrine disorders.
2.Current medication affecting glucose metabolism.
3.Known allergies to test foods.
4.Pregnant/lactating women.
5.Chronic illness or recent major illness.
6.Tobacco/alcohol addiction or recent participation in another study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Incremental Area Under Curve (IAUC 0–120 min).
2. Glycemic Index value (GI = IAUC test / IAUC reference × 100).
|
0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean and 95% CI GI reporting for each test food.
2. Safety/tolerability observations.
|
0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min |
|
|
Target Sample Size
|
Total Sample Size="12" Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - NA
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is an open-label, non-randomized, crossover interventional study designed to evaluate the glycemic index (GI) of selected food products compared with a glucose reference in healthy adult volunteers, in accordance with ISO 26642 methodology. A minimum of 10 healthy adults aged 18 to 60 years will participate in the study. Each participant will serve as their own control and will attend a total of 31 study visits, including screening, repeated reference glucose visits, and multiple test food visits, with a minimum washout period of 3 days between consecutive visits. The order of administration of the glucose reference and test foods will be pre-specified but not balanced or randomized. Following a 10 to 12 hour overnight fast, participants will consume either the glucose reference or a test food portion containing 50 g of available carbohydrates. Blood glucose levels will be measured at baseline and at multiple time points up to 120 minutes post-consumption. The incremental area under the curve will be calculated, and the glycemic index of each test food will be determined relative to the mean response of the glucose reference. Test food products include idly, jaggery, bread, fruit juice, carbohydrate based drinks, rice, chapati, sugar, jam, wheat pudding, payasam, gulab jamun, jalebi, peda, and additional comparable traditional food items. Each test food product will be evaluated on two separate occasions in each participant, and the resulting responses will be compared with the glucose reference.
The primary objective of the study is to determine the glycemic index of the test food products. Secondary objectives include comparison of postprandial glycemic responses, classification of foods as low, medium, or high glycemic index, and assessment of safety and tolerability. Safety will be monitored throughout all study visits. |