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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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  NA

  6. 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.

  7. 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.

 
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