| CTRI Number |
CTRI/2024/12/077621 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Health beverage] |
| Study Design |
Other |
|
Public Title of Study
|
To determine the Glycaemic 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 - Complan VieMax Vanilla and Complan VieMax Chocolate Drink in Healthy Indian Adult Subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B04617; Version: 01, Dated 14 Nov 24 |
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, Behind Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Crossroad, Bodakdev. Phone: 07966135601
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, Behind Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Crossroad, Bodakdev. Phone: 07966135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@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, Behind Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Crossroad, Bodakdev. Phone: 07966135601
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
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
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, Behind Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Crossroad, Bodakdev, Ahmedabad, Gujarat. Phone: 07966135601
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 more than 100 mg/dL, HbA1c level more than 5.7 % and Body Mass Index of 18.5 to 22.9 kg/m2. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Complan VieMax Chocolate with milk |
Test product with 200 ml of warm toned milk will be consumed orally. Single Consumption. |
| Intervention |
Complan VieMax Chocolate with water |
Test product with 250 ml of water will be consumed orally. Single Consumption. |
| Intervention |
Complan VieMax Vanilla with milk |
Test product with 200 ml of warm toned milk will be consumed orally. Single Consumption. |
| Intervention |
Complan VieMax Vanilla with water |
Test product with 250 ml of water will be consumed orally. Single Consumption. |
| Comparator Agent |
Glucon D (Glucose Monohydrate) |
Reference product with 250 mL water will be consumed orally.
Three times Consumption (Single Consumption/day)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects having fasting blood glucose levels more than 100 mg/dL.
2) Subjects having HbA1c level more than 5.7%
3) Subjects with Body Mass Index of 18.5 to 22.9 kg/m2 (both inclusive).
4) Subjects who can understand and provide written informed consent to participate in the study.
5) Subjects who are willing to refrain from vigorous physical exercise during the study period.
|
|
| ExclusionCriteria |
| Details |
1) Subjects with any known food allergy or intolerance to any food or beverages.
2) Subjects who are taking any medication for past one week including home remedies for diabetes or ayurvedic medications or any plant extracts.
3) Pre-diabetic subjects with HbA1c level of 5.7% to 6.4% and diabetic subjects with HbA1c level of 6.5% or higher.
4) Subjects with recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study.
5) Subjects who have participated in any clinical trial within the past 90 days with blood loss more than 450 ml.
6) Subjects 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) Subjects 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 products (when consumed with water), in healthy subjects.
2) To determine the glycemic response of test products (when consumed with milk), in healthy subjects. |
15 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 using an equilateral 7-point rating scale |
15 mins prior to product administration and 0, 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)= "17"
Final Enrollment numbers achieved (India)="17" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
04/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 - Complan VieMax Vanilla and Complan VieMax
Chocolate drink in healthy Indian adult subjects.
Each subject 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. - Visit 01: Screening Visit (Within 30
Days)
- Visit 02: Enrolment
Visit and Admission Day (Day 01) + 1st Product
Administration (Day 02)
- Visit 03: Admission
Day (Day 04) + 2nd Product
Administration (Day 05)
- Visit 04: Admission
Day (Day 07) + 3rd Product
Administration (Day 08)
- Visit 05: Admission Day (Day 10) + 4th Product
Administration (Day 11)
- Visit 06: Admission Day (Day 13) + 5th Product
Administration (Day 14)
- Visit 07: Admission
Day (Day 16) + 6th Product
Administration (Day 17)
- Visit 08: Admission
Day (Day 19) + 7th Product
Administration (Day 20)
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 by the formula: (Blood glucose IAUC value for test products / Average IAUC value of standard glucose) x 100 |