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CTRI Number  CTRI/2025/10/096244 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Health Food Drink]  
Study Design  Other 
Public Title of Study   To determine the Glycemic Index and Glycemic Response of two different flavors of adult nutrition drink. 
Scientific Title of Study   A Randomized, Open Label, Cross Over, Single Centric Clinical Study to determine the Glycemic Index and Glycemic Response of two different flavors - Shelcal Total Vanilla and Shelcal Total Chocolate Drink in Healthy Indian Adult Participants. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
C3B06144; Version: 01, Dated 07 Oct 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. Phone: 079 66135601

Ahmadabad
GUJARAT
380054
India 
Phone  9825784942  
Fax    
Email  ssethi@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Divya Mori 
Designation  Medical Monitor 
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. Phone: 079 66135601

Ahmadabad
GUJARAT
380054
India 
Phone  9773262487  
Fax    
Email  damori@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Altaf Makwana 
Designation  Assistant General Manager- Medical Affairs 
Affiliation  Torrent Pharmaceuticals Ltd. 
Address  Torrent House, Off Ashram Road, Ahmedabad -380009

Ahmadabad
GUJARAT
380009
India 
Phone  7069000569  
Fax    
Email  altafmakwana@torrentpharma.com  
 
Source of Monetary or Material Support  
Torrent Pharmaceuticals Ltd., Torrent House, Off Ashram Road, Ahmedabad 380009, Gujarat, India. Ph: 079 2659 9000 
 
Primary Sponsor  
Name  Torrent Pharmaceuticals Ltd. 
Address  Torrent House, Off Ashram Road, Ahmedabad 380009, Gujarat, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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. | Phone# 079 66135601
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  Shelcal Total Chocolate with milk  25 g available carbohydrates providing test product with 200 ml of warm toned milk will be consumed orally. Single Consumption.  
Intervention  Shelcal Total Chocolate with water  25 g available carbohydrates providing test product with 250 ml of water will be consumed orally. Single Consumption.  
Intervention  Shelcal Total Vanilla with milk  25 g available carbohydrates providing test product with 200 ml of warm toned milk will be consumed orally. Single Consumption.  
Intervention  Shelcal Total Vanilla with water  25 g available carbohydrates providing test product with 250 ml of water will be consumed orally. 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 less than 100 mg/dL.
3) Participants having HbA1c level less than 5.7 %
4) Participants with Body Mass Index of 18.5 to 22.9 kg/m2 (both inclusive).
5) Participants with good general health as determined by the Investigator based on medical history and vital signs.
6) Participants who are literate and can understand and provide written informed consent to participate in the study.
7) Participants who agree to refrain from vigorous physical exercise during the study period.
 
 
ExclusionCriteria 
Details  1) Participants with any known food allergies or intolerance to any food or beverages.
2) Participants who are taking any medication for the past 4 weeks including home remedies for diabetes or ayurvedic medications or any plant extracts.
3) Pre-diabetic participants with HbA1c level of 5.7% to 6.4% and diabetic participants with HbA1c level of 6.5% or higher.
4) Participant with recent history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study.
5) 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.
6) Participants who have tested positive for HIV test.
7) Participants with history of Hepatitis B or C virus. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the glycemic index and glycemic response of test products in healthy participants.  05 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  05 mins prior to product administration and 15, 30, 60, 90 and 120 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)   21/11/2025 
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 different flavors - Shelcal Total Vanilla and Shelcal Total Chocolate Drink in healthy Indian adult participants.

Each participant will receive 7 treatments consisting of the reference product administered on 3 different occasions and 4 administration of test products (both variants in water for GI and both variants in warm toned milk for GR) 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 03)

2nd Product Administration (Day 04)

·       Visit 03: Admission Day (Day 06)

3rd Product Administration (Day 07)

·       Visit 04: Enrolment Visit and Admission Day (Day 09)

4th Product Administration (Day 10)

·       Visit 05: Admission Day (Day 12)

5th Product Administration (Day 13)

·       Visit 06: Admission Day (Day 15)

6th Product Administration (Day 16)

·       Visit 07: Admission Day (Day 18)

                                      7th Product Administration (Day 19)

There will be a washout period of 02 days between doses.

Incremental area under the blood glucose response curve IAUC (0-120 mins), for reference and the test products will be determined for the assessment of glycemic index and glycemic response.

GI/GR score will be calculated using standard formula.

Satiety will be assessed using an equilateral 7-point rating scale at predetermined timepoints
 
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