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CTRI Number  CTRI/2019/11/022001 [Registered on: 14/11/2019] Trial Registered Prospectively
Last Modified On: 27/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [cookies]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Glycemic index of 3 different cookies 
Scientific Title of Study   Glycemic index testing of Cookies 
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  Director 
Affiliation  Madras Diabetes Research Foundation 
Address  No 6B Conransmith Road
Gopalapuram
Chennai
TAMIL NADU
600086
India 
Phone    
Fax    
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Scientific Query
 
Name  Ms Sudha Vasudevan 
Designation  Senior Scientist and Head 
Affiliation  Madras Diabetes Research Foundation 
Address  No6B Conransmith Road Gopalapuram

Chennai
TAMIL NADU
600086
India 
Phone    
Fax    
Email  s2r_7@mdrf.in  
 
Details of Contact Person
Public Query
 
Name  Ms Sudha Vasudevan 
Designation  Senior Scientist and Head 
Affiliation  Madras Diabetes Research Foundation 
Address  No6B Conransmith Road Gopalapuram

Chennai
TAMIL NADU
600086
India 
Phone    
Fax    
Email  s2r_7@mdrf.in  
 
Source of Monetary or Material Support  
Hershey India Pvt. Ltd 
 
Primary Sponsor  
Name  Hershey India Pvt Ltd 
Address  Schindler House Sainath Nagar Powai Mumbai 400076  
Type of Sponsor  Other [Science based Healthcare products developers ] 
 
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 
Ms Sudha Vasudevan  Madras Diabetes Research Foundation  Department of Foods Nutrition and Dietetics Research No.6 Conran smith Road Gopalapuram Chennai 600086
Chennai
TAMIL NADU 
9840014480
914428359035
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  Healthy human volunteers free from any disease and not under any treatment 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  GI Testing of Cookies  3 varieties of Cookies each providing 25/50g available carbohydrate will be given. The cookies will be tested on on 3 different days; Raisin with flax seeds cocoa with flax seeds Mango with almond 
Comparator Agent  Reference Food  Glucose Providing 25/50g available carbohydrate in 200ml water given 3 different occasion 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  BMI greater than 18.9 to less than 22.9 
 
ExclusionCriteria 
Details  Pregnant or lactating Women
BMI greater than 22.9
Thyroid or any other metabolic disorder
Family history of diabetes 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Glycemic index value of cookies  Each cookies will be tested on separate days for 2hrs (o, 15,30,45,60,90 and 120 mins). Similarly reference foods will be tested on 3 different occasions. 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/11/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

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 prevent and treat diabetes . 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 needs to look at cost effective strategies to combat this situation. A cost effective dietary approach like estimating and understanding the role of glycemic index of various Indian foods in the lifestyle related diseases like diabetes is urgently needed. Hence in the present study we aim to evaluate glycemic index (GI) of 3 varieties of Protein cookies with high fibre and omega 3 fatty acids, provided by Hershey India Pvt .Ltd. (Raisin flaxseeds, cocoa & flaxseeds and Mango almond).

 
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