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CTRI Number  CTRI/2024/05/067382 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nutritional]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Utility of low glycaemic index of rice in the management of type 2 diabetes 
Scientific Title of Study   Utility of low glycaemic index of rice in the management of type 2 diabetes: randomized cross-over trial on glycemic control, related parameters and quality of life 
Trial Acronym  RICE TRIAL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ravinder Goswami 
Designation  Professor 
Affiliation  All India Institute of Sciences 
Address  Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  09818130879  
Fax    
Email  gosravinder@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ravinder Goswami 
Designation  Professor 
Affiliation  All India Institute of Sciences 
Address  Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  09818130879  
Fax    
Email  gosravinder@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Ravinder Goswami 
Designation  Professor 
Affiliation  All India Institute of Sciences 
Address  Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  09818130879  
Fax    
Email  gosravinder@hotmail.com  
 
Source of Monetary or Material Support  
Department of Biotechnology.Ministry of Science and Technology, Government of India, CGO complex, Lodhi Road, New Delhi-110003, India 
 
Primary Sponsor  
Name  Department of Biotechnology Ministry of Science and Technology Government of India 
Address  Department of Biotechnology, 7th floor, Block-2, CGO complex, Lodhi Road, New Delhi- 110003, India 
Type of Sponsor  Government funding agency 
 
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 Ravinder Goswami  All India Institute of Medical Sciences, New Delhi  Department of Endocrinology and Metabolism, AIIMS, Ansari Nagar
South
DELHI 
09818130879

gosravinder@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E08-E13||Diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Continue with standard diet pattern without rice  Patints will be randomised in two groups. THese two groups will be cross over for intrevention and comparator purpose. In the first three months, group 2 subjects will be instructed to continue their regular dietary pattern without rice and they will be assessed for their glycaemic status. Group 1 subjects, after first three months of intervention with low glycaemic index rice, would be advised to continue their regular diet without including rice in the diet for next three months of intervention and assessed for their glycaemic status.  
Intervention  Intervention with daily intake of fixed amount of rice with low glycemic index during lunch   Group 1 would be advised to take cooked rice with best low Glycaemic index as the essential meal in the lunch (covering 200 calories) for first three months of the study period. Each subject in group 1 will be given 5 kg rice/every month for 3 months. To achieve total compliance the entire family supply of rice will be given. After cross-over, Group 2 would be advised to take low glycaemic index rice for next three months as described for group 1. All the study participants will be assessed for their glycaemic status during intervention period. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  62 patients with type 2 diabetes mellitus of at least one year duration (male and female), of 30-60 years, with no chronic gastrointestinal, thyroid disorder, food allergies, with HbA1c less than 8.0 % without any chronic micro or macrovascular complications (based on serum creatinine and urinary albumin excretion and fundus examination) would be included. Additional criteria would be willing ness to include rice during lunch every day for three months.  
 
ExclusionCriteria 
Details  Patients with type 2 diabetes mellitus with any chronic micro or macrovascular complications (based on serum creatinine and urinary albumin excretion and fundus examination), on insulin therapy, with active infection, with HbA1c 8.0 % or above will be excluded. Those with resident outside Delhi and NCR would be excluded. Besides, patients with BMI above 35 kg/m2 would also be excluded.  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome would be from the results of use of low glycemic food from patients with T2D. There is possibility that three months of use of low glycaemic index rice would lead to improved compliance with diet, glycemic control as revealed by continuous glucose monitoring and metabolic parameters i.e., glycated hemoglobin.   After 7 months  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the other metabolic parameter i.e, lipid profile and also improvement in the quality of life in type 2 diabetes mellitus patients   After 7 months 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/08/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

India has high burden of type 2 diabetes mellitus (T2D). Glycemic control is important to reduce chronic micro vascular complications. Though lifestyle intervention, dietary changes, and drug therapy are important, quality of life should be maintained by not restriction their long held dietary practices. In practice, patients often request rice for at least once a day in meals to maintain pleasure of eating. However, rice is considered carbohydrate rich worsening glycemic control. We would assess the effect of rice with low glycemic index (GI) on glycemic control, related parameters i.e., insulin, lipids and quality of life in T2D. The study will be carried out in a step wise manner. In stage 1 we would assess GI of 5 rice varieties (four with low and one with high GI) in healthy controls. Stage 2 would assess similar GI in T2D with HbA1c < 8.0%. Stage 3 would be a randomized crossover trial in T2D with intervention of regular intake of low GI rice in meal once per day for 3 months. An open labelled randomized cross-over trial would be carried out in type 2 diabetics with intervention of daily intake of fixed amount of rice with low glycemic index during lunch. After inclusion and exclusion criteria, 62 patients with T2D will be included. At enrolment a detailed history, physical examination including anthropometry, questionnaire on quality of life (SF36), days with dietary compliance in a month as per a visual analogue scale would be recorded. Blood glucose, Lipid profile, HbA1c, other standard investigation including complete blood count, liver and kidney function test would be done. Patients will be block randomized into Group 1 and 2. For first 3 months, group 1 would be advised cooked rice with best low GI as the essential meal in the lunch (covering 200 calories). Each subject in group 1 will be given 5 kg rice/every month for 3 months. To achieve total compliance the entire family supply of rice will be given. Group 2 will be instructed to continue with their regular diet pattern without rice for three months. After one month of wash over period, groups will be crossed with regard to intervention advise  i.e, group 1 will continue standard diet without rice and group 2 will be advised to take low GI rice during lunch for next three months. All subjects will be assessed for glycaemic status including glycated hemoglobin (HbA1c) and glucose moniting by free style Libre during the study period. Final assessment would be carried out at the end of seven months. All investigations which carried out at baseline will be repeated at their last follow-up visit. 

 
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