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CTRI Number  CTRI/2018/04/012979 [Registered on: 03/04/2018] Trial Registered Retrospectively
Last Modified On: 29/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Evaluation of Glycemic Index]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect of a Health food on 2 hours Glucose Response among Overweight Individuals  
Scientific Title of Study   Evaluation of Glycemic Index and Satiety of Celevida: Health food for Special Dietary Use 
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 
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 
Phone  04443968487   
Fax  914428359035  
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 
Phone  04443968487   
Fax  914428359035  
Email  s2r_7@mdrf.in  
 
Source of Monetary or Material Support  
Dr. Reddys Laboratories Ltd. 7-1-27, Greenlands, Ameerpet, Hyderabad 500016  
 
Primary Sponsor  
Name  Madras Diabetes Research Foundation 
Address  Department of Foods Nutrition & Dietetics Research No 4, Conran Smith Road Gopalapuram Chennai  
Type of Sponsor  Other [Non Government Research Organisation] 
 
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 
Dr V Mohan   Madras Diabetes Research Foundation  Department of Foods Nutrition & Dietetics Research No 4 Conran Smith Road Gopalapuram Chennai
Chennai
TAMIL NADU 
914439988816

drmohans@diabetes.ind.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 overweight individuals (BMI greater than or equal to 22.9) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Celevida  2 variants of Celevida (Rasamalai and Chocolate flavours) each mixed with water and milk will be given to study participants 
Comparator Agent  Reference Glucose  Glucose is given as reference food thrice during the study period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.BMI greater than or equal to 22.9 kg/ m2
2.Participants with family history of diabetes
3.Willingness to consume the test foods
 
 
ExclusionCriteria 
Details  1.Underweight
2.Specific diet restriction (weight reduction, low fat, salt restriction diet)
3.Suffering from any chronic illness or medical condition (Heart disease, diabetes, high blood pressure, renal or kidney disease, anaemia)
4.Pregnant and lactating mother
5.Food allergy
6.Physically challenged 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessing the glycemic index, GI category and satiety of food products  3 months 
 
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)   16/03/2018 
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)  Open to Recruitment 
Publication Details   Not yet  
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 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 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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