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CTRI Number  CTRI/2024/11/076235 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Rice sample]  
Study Design  Other 
Public Title of Study   Glycemic Index of Lalat Rice variety 
Scientific Title of Study   Glycemic index of ICAR-NRRI variety Improved Lalat 
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  President & Chief of Diabetes Research 
Affiliation  Madras Diabetes Research Foundation 
Address  Foods, Nutrition and Dietetics Research, Madras Diabetes Research Foundation No 4, Conran Smith Road, Gopalapuram,

Chennai
TAMIL NADU
600086
India 
Phone  9840014480  
Fax  914428359035  
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Scientific Query  
Name  Dr V Mohan 
Designation  President & Chief of Diabetes Research 
Affiliation  Madras Diabetes Research Foundation 
Address  Foods, Nutrition and Dietetics Research, Madras Diabetes Research Foundation No 4, Conran Smith Road, Gopalapuram,


TAMIL NADU
600086
India 
Phone  9840014480  
Fax  914428359035  
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Public Query  
Name  Mrs Sudha Vasudevan 
Designation  Senior Scientist and Head- Department of Foods, Nutrition & Dietetics Research 
Affiliation  Madras Diabetes Research Foundation 
Address  Foods, Nutrition and Dietetics Research, Madras Diabetes Research Foundation No 4, Conran Smith Road, Gopalapuram,

Chennai
TAMIL NADU
600086
India 
Phone  9840014480  
Fax  914428359035  
Email  s2r_7@mdrf.in  
 
Source of Monetary or Material Support  
The Director ICAR-National Rice Research Institute, Cuttack- 753006 (Odisha), India 
 
Primary Sponsor  
Name  Madras Diabetes Research Foundation 
Address  Department of Foods, Nutrition and Dietetics Research, Madras Diabetes Research Foundation, 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 
Dr V Mohan  Madras Diabetes Research Foundation  Department of Foods, Nutrition and Dietetics Research, NO. 4, Conron Smith Road,
Chennai
TAMIL NADU 		 439688888
914428359035
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  Health participants with normal BMI 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cooked plain white rice  50/25 g available carbohydrate providing cooked improved lalat variety rice will be given as test food on separate ocassion agent to study participants as test food once on a separate day and capillary blood samples will be collected for the subsequent 2 hours 
Comparator Agent  Reference glucose  25g/50g available carbohydrate providing glucose in 250/125ml water will be given as reference food three times during the study period on separate occasions randomized in-between the test food. Capillary blood samples will be collected for the subsequent 2 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Age -18 to 45 years
BMI ≥18.5 to ≤ 22.9 kg/ m2 (as per WHO cut off for normal BMI)
Both male and female
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   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To measure glycemic index (GI) of ICAR-NRRI improved Lalat variety  Glycemic index testing of all 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/bite 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)   10/11/2024 
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   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 diabetic participants 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 ICAR-NRRI improved Lalat variety
 
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