FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090487 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Biscuits]  
Study Design  Other 
Public Title of Study   To determine the Glycaemic Index of two Biscuits. 
Scientific Title of Study   A Randomized, Cross Over, Single Centric Clinical Study to Determine the Glycemic Index of Two Test Biscuits in Healthy Indian Adult Participants. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
C3B05335; Version: 01, Dated 27 Jun 25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Simran Sethi 
Designation  Principal Investigator 
Affiliation  Cliantha Research  
Address  Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat.

Ahmadabad
GUJARAT
380054
India 
Phone  9825784942  
Fax    
Email  ssethi@cliantha.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Simran Sethi 
Designation  Principal Investigator 
Affiliation  Cliantha Research  
Address  Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat.

Ahmadabad
GUJARAT
380054
India 
Phone  9825784942  
Fax    
Email  ssethi@cliantha.com   
 
Details of Contact Person
Public Query  
Name  Ms Manasa P S 
Designation  Group Manager - Nutrition 
Affiliation  Britannia Industries Limited 
Address  R & D Centre, Bidadi, Ramanagara District, Bangalore - 562 109, Karnataka

Bangalore
KARNATAKA
562 109
India 
Phone  9886988763  
Fax    
Email  manasaps@britindia.com  
 
Source of Monetary or Material Support  
Britannia Industries Limited, Prestige Shantiniketan, Tower C, The Business Precinct, 16th & 17th Floor, Whitefield Main Road, Mahadevapura, Bengaluru, Karnataka 560048. 
Cliantha Research, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat, India. 
 
Primary Sponsor  
Name  Britannia Industries Limited 
Address  Prestige Shantiniketan, Tower C, The Business Precinct, 16th & 17th Floor, Whitefield Main Road, Mahadevapura, Bengaluru, Karnataka 560048. 
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Simran Sethi  Cliantha Research  Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat.
Ahmadabad
GUJARAT 		 9825784942

ssethi@cliantha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OM Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy, adult, male and non-pregnant/non-lactating female participants with fasting blood glucose levels 100 mg/dL, HbA1c level 5.7 % and Body Mass Index of 18.5 to 22.9 kg/m2. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Glucon D (Glucose Monohydrate)  25 g available carbohydrates providing glucose in 250 mL water will be given as reference food three times during the study period on separate occasions. 
Intervention  NutriChoice Advanced Oats Cookies(Formerly known as NutriChoice Oats Cookies)  25 g available carbohydrates providing biscuit will be given to study participants as test food. Single Consumption. 
Intervention  NutriChoice Advanced Ragi Cookies(Formerly known as NutriChoice Ragi Cookies)  25 g available carbohydrates providing biscuit will be given to study participants as test food. Single Consumption. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1) Healthy, adult male and non-pregnant/non-lactating female participants between the ages of 18 to 45 years both inclusive at the time of consent.
2) Participants having fasting blood glucose levels below100 mg/dL.
3) Participants having HbA1c level below 5.7 %
4) Participants with Body Mass Index of 18.5 to 22.9 kg/m2 (both inclusive).
5) Female participants of childbearing potential must have a negative urine pregnancy test performed during screening.
6) Participants who agree to refrain from vigorous physical exercise during the study period.
7) Participants with no medications known to affect glucose tolerance (excluding oral contraceptives) — stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis.
8) Participants with no history of cardiovascular disease.
9) Participants who have not donated blood within 30 days prior to screening.
 
 
ExclusionCriteria 
Details  1) Participants with any known food allergy or intolerance to any food or beverages.
2) Participants with allergies to wheat, gluten, dairy, or other common biscuit ingredients.
3) Participants with presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g., Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
4) Participants with recent history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to the study.
5) Participants who have participated in any clinical trial within the past 90 days with blood loss more than 450 mL.
6) Participants who are on an unusual diet, special diet, for whatever reason e.g., high protein diet, low sodium diet, intermittent fasting for two weeks prior to receiving any reference/test product and throughout participant’s participation in the study.
7) Participants who have tested positive for HIV test
8) Participants having history of Hepatitis B or C virus.
9) Participants with a known history of diabetes mellitus or the use of anti-hyperglycaemic drugs or insulin to treat diabetes and related conditions.
10) Participants with the presence of disease or drug(s) which influence digestion and absorption of nutrients.
11) Participants with the use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution).
12) Participants with a history of significant gastrointestinal disorders (e.g., inflammatory bowel disease, gastroparesis) that could affect absorption or digestion.)
13) Participants with any known kidney or liver disease. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the glycemic index of test products, in healthy participants.  5 mins prior to product administration, 0 min and 15, 30, 45, 60, 90 and 120 minutes post product administration on each product administration day. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Satiety level using an equilateral 7-point rating scale.  5 mins prior to product administration, 0 min and 15, 30, 60, 90, 120, 180 and 240 minutes post product administration on each product administration day. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   04/08/2025 
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="0"
Months="0"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a randomized, open label, cross over, single centric clinical study to determine the Glycemic Index and Glycemic Response of two biscuits in healthy Indian adult participants.

Each participant will receive 5 treatments consisting of the reference product administered on 3 different occasions and 2 administration of test biscuits as per the randomization schedule.

·       Screening Visit (Within 15 Days)

·       Visit 01: Enrolment Visit and Admission Day (Day 00)

1st Product Administration (Day 01)

·       Visit 02: Admission Day (Day 04)

2nd Product Administration (Day 05)

·       Visit 03: Admission Day (Day 08)

3rd Product Administration (Day 09)

·       Visit 04: Enrolment Visit and Admission Day (Day 12)

4th Product Administration (Day 13)

·       Visit 05: Admission Day (Day 16)

5th Product Administration (Day 17)

There will be a washout period of 03 days between doses to prevent the carry-over effect of the previous visit day’s reference or test food intake.

Incremental area under the blood glucose response curve (IAUC)  [Predose (5 mins ± 1 min), 0 min (+ 1 min), 15 mins (± 2 mins), 30 mins (± 2 mins), 45 mins (± 2 mins), 60 mins (± 2 mins), 90 mins (± 2 mins) and 120 mins (± 2 mins)], for reference and the test products will be determined for the assessment of glycemic index.

GI score will be calculated by the formula: 

GI = Blood Glucose IAUC value for test products/Average IAUC value of standard glucose * 100             

Satiety will be assessed using an equilateral 7-point rating scale at Predose (5 mins ± 1 min), 0 minute (+ 1 mins) (i.e., the time when the first bite in the mouth is taken) and after administration of product, at 15, 30, 60, 90, 120, 180 and 240 minutes (+5 mins – window period is for all time-points after product administration).

 
Close