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CTRI Number  CTRI/2021/01/030412 [Registered on: 12/01/2021] Trial Registered Prospectively
Last Modified On: 04/01/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Health drink]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect of a Health drink on 2 hours Glucose Response among Normal Individuals 
Scientific Title of Study   Evaluation of Glycemic Index of vidavance 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V Mohan 
Designation  President and Chief of Diabetes Research 
Affiliation  MADRAS DIABETES RESEARCH FOUNDATION 
Address  Department of Foods Nutrition and Dietetics Research Madras Diabetes Research Foundation No 4 Conran Smith Road Gopalapuram Chennai TAMIL NADU 600086 India



600086
Other 
Phone  914439988816  
Fax    
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Scientific Query  
Name  Mrs Sudha Vasudevan 
Designation  Senior Scientist & Head- Department of Foods Nutrition & Dietetics Research 
Affiliation  MADRAS DIABETES RESEARCH FOUNDATION 
Address  Department of Foods Nutrition & Dietetics Research Madras Diabetes Research Foundation No 4 Conran Smith Road Gopalapuram Chennai TAMIL NADU 600086 India

Chennai
TAMIL NADU
600086
India 
Phone  04443968487  
Fax    
Email  s2r_7@mdrf.in  
 
Details of Contact Person
Public Query  
Name  Mrs Sudha Vasudevan 
Designation  Senior Scientist & Head- Department of Foods Nutrition & Dietetics Research 
Affiliation  Madras Diabetes Research Foundation 
Address  Department of Foods Nutrition & Dietetics Research Madras Diabetes Research Foundation No 4 Conran Smith Road Gopalapuram Chennai TAMIL NADU 600086 India

Chennai
TAMIL NADU
600086
India 
Phone  04443968487  
Fax    
Email  s2r_7@mdrf.in  
 
Source of Monetary or Material Support  
Modi-Mundipharma Pvt. Ltd. 1400, Modi Tower 98, Nehru Place, New Delhi 110019, India  
 
Primary Sponsor  
Name  ModiMundipharma Pvt Ltd 
Address  1400, Modi Towers 98 Nehru place,New Delhi 110019, 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 
Mrs Sudha Vasudevan  MADRAS DIABETES RESEARCH FOUNDATION  Madras Diabetes Research Foundation Department of Foods Nutrition and Dietetics Research No. 4 Conran smith Road, Gopalapuram, Chennai-600086
Chennai
TAMIL NADU 		 9840014480

s2r_7@mdrf.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Madras Diabetes Research Foundation Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Male and female normal individuals (BMI less than or equal to 22.9) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Reference Glucose  Glucose providing 25/50g available carbohydrate is given as reference food thrice during the study period 
Intervention  Vidavance  Vidavance providing 25/50g available carbohydrate mixed with water will be given to study participants 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  BMI ≤ 22.9 kg/ m2
Willingness to consume the test foods
no known food allergy or intolerance;
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 are acceptable.
 
 
ExclusionCriteria 
Details  a known history of diabetes mellitus or the use of anti-hyperglycaemic drugs or insulin to treat diabetes and related conditions
pregnant or lactating women
a major medical or surgical event requiring hospitalization within the preceding 3 months;
the presence of disease or drug(s) which influence digestion and absorption of nutrients;
the use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will elicit the glycemic index, GI category vanilla flavored vidavance drink.   Capillary glucose will be assessed 8 times on each test day(2 times in fasting and 15,30,45,60,90,120 mins post consumption of test and reference food on 2 separate occasions.  
 
Secondary Outcome  
Outcome  TimePoints 
Assessing the proximates and available
carbohydrates of food products 		 7 days 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   18/01/2021 
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="3"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Research studies have shown that lifestyle, in particular dietary aspects play an important role in
preventing / increasing the burden of the chronic diseases. Dietary habits could therefore be
modified to exert a positive impact in the prevention and treatment. It has been suggested that the
high glycemic carbohydrate foods – those foods containing carbohydrates which elicit rapid blood
glucose rise and thereby increase the insulin demand leading to hyperinsulinemia, insulin
resistance and type 2 diabetes. Hence, there is a need to understand the blood glucose raising
potential of foods in India to be of an important tool to aid in the prevention and or management of
diabetes and its complication. Thus evolved the concept of ‘Glycemic Index’ (GI) which ranks the
foods, based on the speed at which the food raises the blood glucose in a scale of 0 to 100, 100
indicating high glycemic index corresponds to oral glucose’s GI. Today, India leading the world with
the largest number of diabetic volunteers causing a heavy economic burden to the country urgently
need to look at cost effective strategies to combat this situation. A cost effective dietary approach
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REF/2018/03/018745
CTRI Website URL - http://ctri.nic.in
like estimating and understanding the role of glycemic index of various Indian foods in the lifestyle
related diseases like diabetes is urgently needed. Capillary blood glucose will be measured at 0, 15,
30, 45, 60, 90 and 120 min using Hemocue Glucose 201+ analyzer (Hemocue®Ltd, Angelholm,
Sweden). Standard glucose drink will be given for 3 different days to get average glucose response
and each test food for 1 day with a wash out period of 2 to 3 days between each test day. The GI
was calculated as IAUC of test food/IAUC of reference (Glucose) food x 100.

 
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