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CTRI Number  CTRI/2025/07/090027 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Wheat Line Based Chapathi]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Glycemic Index testing of 4 wheat lines based Chapathis 
Scientific Title of Study   Glycemic index testing of 4 wheat lines 
Trial Acronym  NIL 
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  Chairman 
Affiliation  Madras Diabetes Research Foundation 
Address  Department of Foods Nutrition and Dietetics Research, No 4, Conran Smith Road, Gopalapuram

Chennai
TAMIL NADU
600086
India 
Phone  04439688888  
Fax    
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Scientific Query  
Name  Dr V Mohan 
Designation  Chairman 
Affiliation  Madras Diabetes Research Foundation 
Address  Department of Foods Nutrition and Dietetics Research, No 4, Conran Smith Road, Gopalapuram

Chennai
TAMIL NADU
600086
India 
Phone  04439688888  
Fax    
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Public Query  
Name  Mrs Sudha Vasudevan 
Designation  Sr Scientist and HOD 
Affiliation  Madras Diabetes Research Foundation 
Address  Department of Foods Nutrition and Dietetics Research, No 4, Conran Smith Road, Gopalapuram

Chennai
TAMIL NADU
600086
India 
Phone  9840014480  
Fax    
Email  s2r_7@mdrf.in  
 
Source of Monetary or Material Support  
National Agri-Food Biotechnology Institute (NABI) (Department of Biotechnology, Government of India) Sector 81, Knowledge city, Mohali, Punjab, India -140306  
 
Primary Sponsor  
Name  Madras Diabetes Research Foundation  
Address  Department of Foods Nutrition and Dietetics Research, No 4, Conran Smith Road, Gopalapuram, Chennai, India-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 
Dr V Mohan  Madras Diabetes Research Foundation  Department of Foods Nutrition and Dietetics Research, No 4, Conran Smith Road, Gopalapuram, Chennai, India 600086
Chennai
TAMIL NADU 		 9840014480

drmohans@diabetes.ind.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MadrasDiabetesResearchFoundationInstitutionalEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy participants with normal body mass index  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chapathi   4 Variants of chapathis made with 4 wheat lines- black wheat flour, white wheat flour, Sphaerococcum wheat (wheat flour), and 20% soy–wheat composite flour will be given as a test foods -each providing 50g available carbohydrate each will be tested on 4 different days. The GI Testing of foods will be done in fasting state. The test food will be given on 1 day for each in-between reference foods. 
Comparator Agent  Reference Glucose   Glucose drink providing 50g available carbohydrate will be given as reference food on 3 different days during the study period  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  BMI greater than equal to 18.5 to less than
equal to 22.9 kg/ m2 (as per WHO cut offfor 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, acetylsalicylicacid, thyroxin, vitamins and mineralsupplements 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 totreat diabetes and related conditions
Pregnant or lactating women
A major medical or surgical event requiring hospitalization within the preceding 3months
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 majoreffectson glucose metabolism and body fat distribution).  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Glycemic index and GI category of the test foods.   Glycemic index testing of reference and test foods will be done
on separate days. For both intervention and
comparator agents capillary blood samples will
be collected at -5,0 (fasting state) and at
15,30,45,60,90,120 mins from the first sip of test
and reference foods. 
 
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)   30/07/2025 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   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 people with diabetes 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.

Aim: To measure glycemic index (GI) of chapathi made from 4 wheat lines. 
 
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