| CTRI Number |
CTRI/2026/01/101454 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [High Protein & Fiber Food] |
| Study Design |
Other |
|
Public Title of Study
|
To determine the Glycemic Index & Glycemic response of test products. |
|
Scientific Title of Study
|
A Randomized, Open Label, Cross Over, Single Centric, Accessor Blinded, Clinical Study to determine the Glycemic Index & Glycemic response of test products in Healthy Indian Adult Participants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B05954; Version: 01, Dated 08 Jan 26 |
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 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-380054, Gujarat.
Ahmadabad
GUJARAT
380054
India |
| Phone |
9773262487 |
| Fax |
|
| Email |
damori@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth Joshi |
| Designation |
Sub - 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 |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| 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. |
| Zydus Wellness Products Limited, Plot No 115/5 TP Scheme No 51, Besides Bliss Apartment, Opp Viola Apartment, Ambli Bopal Road, Ahmedabad 380015. |
|
|
Primary Sponsor
|
| Name |
Zydus Wellness Products Limited |
| Address |
Plot No 115/5 TP Scheme No 51, Beside Bliss Apartment, Opp Viola Apartment, Ambli Bopal Road, Ahmedabad 380015 |
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy, adult, male and non-pregnant/non-lactating female subjects with fasting blood glucose levels 100 mg/dL, HbA1c level less than 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 |
Viemax Diabetes Care (Kesar Badam) |
25 g available carbohydrates providing test product will be served with 300 ml water. Single Consumption. |
| Intervention |
Viemax Diabetes Care (Vanilla) |
25 g available carbohydrates providing test product will be served with 200 ml milk. Single Consumption. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Participants having fasting blood glucose levels less than 100 mg/dL.
2) Participants having HbA1c level less than 5.7 percentage.
3) Participants with Body Mass Index of 18.5 to 22.9 kg/m2 (both inclusive).
4) Participants who can understand and provide written informed consent to participate in the study.
5) Participants who are willing to refrain from vigorous physical exercise during the study period. |
|
| ExclusionCriteria |
| Details |
1) Participants with any known food allergy or intolerance to any food or beverages.
2) Participants who are taking any medication for past one week 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) Participants with recent history of dehydration from diarrhoea, 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, for two weeks prior to receiving any reference/test product and throughout subject’s participation in the study.
7) Participants having history of Hepatitis B or C virus. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To determine the glycemic index of test product, in healthy participants.
2) To determine the glycemic response (when consumed with milk) of test product, in healthy participants. |
05 mins prior to product administration and 0, 15, 30, 45, 60, 90 and 120 minutes post product administration on each product administration day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Satiety level (in terms of feeling of hunger, fullness, satisfaction and desire to eat) using Visual Analogue Scale (VAS) |
5 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)
|
30/01/2026 |
| 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="0"
Months="1"
Days="0" |
|
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, accessor blinded clinical study to determine the Glycemic Index & Glycemic response of test product 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 product (One product with water for GI and other product with 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) 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. GI/GR score will be calculated by the formula: 
|