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CTRI Number  CTRI/2022/08/044890 [Registered on: 24/08/2022] Trial Registered Prospectively
Last Modified On: 23/08/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Foods]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Glycemic index testing of beverage-meal replacement and a herbal paste  
Scientific Title of Study   Evaluation of glycemic index and glycemic response of nutrition supplement [meal replacements (n=3) and a multi-ingredient herbal paste (n=1) 
Trial Acronym  NA 
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 & Chief of Diabetes Research 
Affiliation  MADRAS DIABETES RESEARCH FOUNDATION 
Address  6B Conron Smith Road Gopalapuram

Chennai
TAMIL NADU
600086
India 
Phone    
Fax    
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Scientific Query  
Name  Sudha Vasudevan 
Designation  Senior Scientist & Head- Department of Foods Nutrition & Dietetics Research 
Affiliation  MADRAS DIABETES RESEARCH FOUNDATION 
Address  6B Conron Smith Road Gopalapuram

Chennai
TAMIL NADU
600086
India 
Phone    
Fax    
Email  s2r_7@mdrf.in  
 
Details of Contact Person
Public Query  
Name  Sudha Vasudevan 
Designation  Senior Scientist & Head- Department of Foods Nutrition & Dietetics Research 
Affiliation  MADRAS DIABETES RESEARCH FOUNDATION 
Address  6B Conron Smith Road Gopalapuram


TAMIL NADU
600086
India 
Phone    
Fax    
Email  s2r_7@mdrf.in  
 
Source of Monetary or Material Support  
Amway Global Services India Pvt.Ltd 
 
Primary Sponsor  
Name  Madras Diabetes Research Foundation 
Address  No 4 Conran smith Road, Gopalapuram,Chennai-600086  
Type of Sponsor  Research institution 
 
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  Department of foods nutrition and dietetics research 6B Conron Smith Road Gopalapuram
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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human participants with normal body mass index and free of disease 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Reference Food  25/50g available carbohydrate providing glucose in 125/250g water will be given as reference food on 3 different occasions. 
Intervention  Test food  25/50g available carbohydrate providing meal replacement- BDK-01+ protein powder-PRP-02 with water will be given once 
Intervention  Test food  25/50g available carbohydrate providing multi ingredient herbal paste-IBY03 with BDK-01 meal replacement with water will be given once 
Intervention  Test food  25/50g available carbohydrate providing test food-BDK-01 meal replacement with water will be given once 
Intervention  Test food  25/50g available carbohydrate providing test food-BDK-02 meal replacement with skimmed milk will be given once 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details 
BMI more than 18.5 to less than 22.9 kg/ m2 (as per WHO cut off for normal BMI)
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-hyperglycemic 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   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Glycemic index and response of meal replacements and herbal paste compared to reference glucose  Capillary blood samples will be collected at 0 min- fasting and 4 times at an interval of 15 mins-15,30,45,60 mins and 2 times at interval of half an hour-90 and 120 mins for each test and reference food to determine the glycemic index. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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)   25/09/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
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 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.

 
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