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CTRI Number  CTRI/2025/08/093868 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 14/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Limiting Meal or Size – Which is Effective in treating Type 2 Diabetes Mellitus patients? 
Scientific Title of Study   Limiting Meal Frequency (3 Larger Meals a Day) or Meal Size (Diabetic Plate) — Which is Effective in the Management of Type 2 Diabetes Mellitus? A Pragmatic Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sembagamuthu Sembiah 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Kalyani 
Address  303. Dept. OF CMFM
AIIMS Kalyani, Saguna, NH-34 Connector, Basantapur,
Nadia
WEST BENGAL
741245
India 
Phone  7904060377  
Fax    
Email  sembagamuthu.cmfm@aiimskalyani.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Sembagamuthu Sembiah 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Kalyani 
Address  303. Dept. OF CMFM
AIIMS Kalyani, Saguna, NH-34 Connector, Basantapur,
Nadia
WEST BENGAL
741245
India 
Phone  7904060377  
Fax    
Email  sembagamuthu.cmfm@aiimskalyani.edu.in  
 
Details of Contact Person
Public Query  
Name  Sembagamuthu Sembiah 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Kalyani 
Address  303. Dept. OF CMFM
AIIMS Kalyani, Saguna, NH-34 Connector, Basantapur,
Nadia
WEST BENGAL
741245
India 
Phone  7904060377  
Fax    
Email  sembagamuthu.cmfm@aiimskalyani.edu.in  
 
Source of Monetary or Material Support  
Multi-disciplinary Research Unit (AIIMS Kalyani) under Department of Health Research, Government of India. Address: Department of Health Research, 2nd Floor, IRCS Building, 1, Red Cross Road, New Delhi - 110001. India 
 
Primary Sponsor  
Name  Multi-disciplinary Research Unit under Department of Health Research. GoIHR 
Address  Department of Health Research 2nd Floor, IRCS Building, 1, Red Cross Road, New Delhi - 110001. 
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 Sembagamuthu Sembiah  UPHC 2 KALYANI NADIA  UPHC-2, Picnic Garden, Ward No 6, Kalyani
Nadia
WEST BENGAL 		 7904060377

sembagamuthu.cmfm@aiimskalyani.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Limiting meal frequency (3 larger meals a day)  Participants will be asked to take large meals three times a day for 3 months. Neither Portion size nor calorie amount will be calculated, the participants will be asked to take the food amount as usual before. Another condition is to take the food 2 hours before sleep. Every month, the participants will be asked to visit the health center to assess whether they are following the intervention plan; blood glucose will be assessed. All the anthropometric, patient-centered outcomes such as treatment satisfaction and efficacy and biochemical parameters will be collected at baseline and 12 weeks after.  
Intervention  Portion control using diabetic plate  The plate method provides participants with sized plates (9-inch) and bowls (4 and 8 ounces) and instructs them on how much of different types of foods they can consume. Participants are typically instructed that they can use ½ the plate “free” foods such as low-carbohydrate, non-starchy vegetables, ¼ of the plate for their protein such as meat or eggs, and ¼ of the plate for carbohydrates. The particpants will be provided with standardized katoris for different food groups to improve the precision of portion sizes. No meal frequency or calorie restrictions. Participants will be asked to use this diabetic plate for 3 months. Every month, the participants will be asked to visit the health center to assess whether they are following the intervention plan; blood glucose will be assessed. All the anthropometric, patient-centered outcomes such as treatment satisfaction and efficacy and biochemical parameters will be collected at baseline and 12 weeks after. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Currently diabetic, as defined by HbA1c ≥6.5gm% and/or current antidiabetic medication.
2. Diabetic duration: less than or equal to 12 months. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Difference in
1. HbA1c
2. fasting and post prandi9al glucose
3. fasting insulin
 		 baseline and end of 3 months.
 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in
1. fasting lipid profile,
2. β-cell function
3. Insulin Resistance
4. treatment satisfaction
5. Medication Adherence 		 baseline and end of 3 months.  
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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)   24/09/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  
Background: One out of 11 Indians formally diagnosed with diabetes, makes India second most affected in the world. Restricted diet pattern has the greatest impact on the management of DM, but these are complex and difficult to comply.
Novelty: There is an unmet need to evolve dietary strategies from pragmatic trials. A simplified approach that can be easily understandable as well as implemented at low literacy and resource constraint settings is imperative for management of T2DM.
Objective: To compare the effectiveness of interventions: restricted meal frequency and meal size in uncomplicated diabetic patients attending the urban NCD clinic of AIIMS Kalyani.
Methods: Two-arm parallel Open-label controlled pragmatic trial with 1:1 allocation ratio using permutated block randomization technique.
Expected outcomes: Change in biomarkers of glucose metabolism (i.e., fasting and 2-hour postprandial glucose and hemoglobin A1c), lipid profile, weight, waist-hip ratio, and perceived treatment satisfaction and efficacy levels.
Applicability: These study findings aid in the effective management and reversal of T2DM. These interventions shall be incorporated into the policies at the national level to reduce the burden of primary health care.
 
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