FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056087 [Registered on: 03/08/2023] Trial Registered Prospectively
Last Modified On: 14/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Glycaemic Index Evaluation]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Assessment of Glycaemic Index of test food(s) in Healthy Adult Human Subjects 
Scientific Title of Study   Evaluation of Glycaemic Index of test food(s) in Healthy Adult Human Subjects using ISO 26642 method. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NB230020-ZW Version (01) Final 17 Jun 23  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Principal Investigator - Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj Gandhinagar

Gandhinagar
GUJARAT
382421
India 
Phone  9909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator - Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj Gandhinagar


GUJARAT
382421
India 
Phone  9909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Maheshvari Patel 
Designation  Director Operations and Strategic Management 
Affiliation  NovoBliss Research Private Limited 
Address  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj Gandhinagar

Gandhinagar
GUJARAT
382421
India 
Phone  9909013286  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
Zydus Wellness Limited, Plot No. 115/5, TP Scheme No. 51 Off Ambli - Bopal, Road, Makarba, Ahmedabad, Gujarat 380058 
 
Primary Sponsor  
Name  Zydus Wellness Limited 
Address  Plot No. 115/5, TP Scheme No. 51 Off Ambli - Bopal, Road, Makarba, Ahmedabad, Gujarat 380058 
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  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 Nayan Patel  NovoBliss Research Pvt. Limited  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj Gandhinagar
Gandhinagar
GUJARAT 		 9909013286

dr.nayan@novobliss.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS – Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Subjects having fasting blood glucose level less than 100 mg/dL. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Anhydrous Glucose Powder 25g  Mode of Usage: Consume 25g of anhydrous glucose powder with 250 ml of water within 15 minutes. Route of Administration: Oral 
Intervention  Protein-Based Product 33.8g with water  Mode of Usage: Consume the protein based product X g with 250 mL of water within 15 minutes. Route of Administration: Oral 
Intervention  Protein-Based Product 40.3g with water  Mode of Usage: Consume the protein based product 40.3g with 250 mL of water within 15 minutes. Route of Administration: Oral 
Intervention  Protein-Based Product 40.3g with water  Mode of Usage: Consume the protein based product 40.3g with 250 mL of water within 15 minutes. Route of Administration: Oral 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1) Age: 18 to 45 years (both inclusive) at the time of consent
2) Sex: male and non-pregnant/non-lactating female.
3) Females of childbearing potential must have a negative urine pregnancy test performed on
screening visits.
4) Subjects having fasting blood glucose levels <100 mg/dL.
5) Subjects with a Body Mass Index of 18.5 to 25 kg/m2 (both inclusive).
6) Subject is in good general health as determined by the Investigator on the basis of medical
history and vital signs.
7) Subjects should be willing and able to follow the study protocol to participate in the study.
8) Subject must be able to understand and provide written informed consent to participate in the
study.
9) Subject is willing to refrain from vigorous physical exercise during the study period. 
 
ExclusionCriteria 
Details  1) Subject has any known food allergy or intolerance to any food or beverages.
2) Subject is taking any medication in the past one week.
3) Subjects should not be taking any 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 are
acceptable
4) Subjects should not have any known food allergy or intolerance
5) 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.
6) Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of24 hours prior to the study.
7) Subject consuming any medication in the past one week.
8) Participation in any similar clinical trial within the past 90 days with blood loss more than 450 mL.
9) An unusual diet, special diet, for whatever reason e.g. high protein diet, low sodium diet, for two weeks prior to receiving any test food and throughout the subject’s participation in the
study.
10) Subject has performed vigorous physical exercise in the morning on dosing day.
11) Pregnant or lactating females.
12) Self reported Positive HIV test.
13) History of Hepatitis B or C virus self-reported.
Any exceptions to the inclusion/exclusion criteria will be considered on a case-by case basis and will be documented in the case report form. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the glycaemic index of Test foods in healthy subjects by using the in-vivo method.  15 minute before consumption of test food to after consumption of test food at 15, 30, 45, 60, 90 & 120 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of Test foods in terms of the satiety level (for hunger, fullness & desire to eat) by using visual analogue scale based subjective questionnaires  15 minute before consumption of test food to after consumption of test food at 30, 60, 90, 120, 180 & 240 minutes 
To assess the safety of the Test foods in terms of adverse events reported by subjects or assessed by Investigator  After consumption of test food at Day 01,Day 05,Day 09,Day 16, & Day 23 
To assess the Calorie Index of test products containing carbohydrates using standard calculation method.  After consumption of reference food & test food on Day 1, Day 5, Day 9, Day 16, Day 23 
To assess the Glycaemic Load of test products containing carbohydrates using standard calculation method  After consumption of reference food & test food on Day 1, Day 5, Day 9, Day 16, Day 23 
 
Target Sample Size   Total Sample Size="6"
Sample Size from India="6" 
Final Enrollment numbers achieved (Total)= "6"
Final Enrollment numbers achieved (India)="6" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/08/2023 
Date of Study Completion (India) 13/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="23" 
Recruitment Status of Trial (Global)
Modification(s)  		 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  
The objective of this study is to evaluate the glycaemic index of test food in healthy adult human subjects using the ISO 26642 method.
This is a double-blind, randomized, three-arms, three-way, Crossover, in-vivo glycaemic index study in healthy subjects.
To get 5 evaluable subjects, a maximum of 6 subjects will be enrolled.
Evaluation Visit:
There are a total of 5 visits during the study.  The screening will be performed within 30 days. In all the visits overnight stay and fasting will be performed. The subject will report at the clinical site in the evening, maximum of 10 hours of fasting will be performed. No food should be allowed for the subjects after 10 pm.
Visit 1 and Visit 2 for 1st and 2nd reference food consumption respectively and Visit 3 to Visit 5 for test food 1, 2, and 3 consumption respectively. Blood will be collected before and after reference and test food consumption. 
The statistical analysis will be performed after completion of the study.


 
Close