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CTRI Number  CTRI/2026/01/100664 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nutritional/Diet]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Study on the effect of healthier Indian traditional meals on blood glucose and insulin in overweight or obese women 
Scientific Title of Study   Clinical evaluation of glycemic response, insulinemic response and satiety of plant-based diabetic-friendly Indian traditional mixed meals in overweight/obese women in India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srividya Nagarajan 
Designation  Professor 
Affiliation  Sri Sathya Sai Institute of Higher Learning (Deemed to be University) 
Address  Department of Food and Nutritional sciences. Sri Sathya Sai Institute of Higher Learning (Deemed to be University). Anantapur Campus Anantapur Andhra Pradesh

Anantapur
ANDHRA PRADESH
515001
India 
Phone  9110380460  
Fax    
Email  nsrividya@sssihl.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Srividya Nagarajan 
Designation  Professor 
Affiliation  Sri Sathya Sai Institute of Higher Learning (Deemed to be University) 
Address  Department of Food and Nutritional sciences. Sri Sathya Sai Institute of Higher Learning (Deemed to be University). Anantapur Campus Anantapur Andhra Pradesh

Anantapur
ANDHRA PRADESH
515001
India 
Phone  9110380460  
Fax    
Email  nsrividya@sssihl.edu.in  
 
Details of Contact Person
Public Query
 
Name  Srividya Nagarajan 
Designation  Professor 
Affiliation  Sri Sathya Sai Institute of Higher Learning (Deemed to be University) 
Address  Department of Food and Nutritional sciences. Sri Sathya Sai Institute of Higher Learning (Deemed to be University). Anantapur Campus Anantapur Andhra Pradesh

Anantapur
ANDHRA PRADESH
515001
India 
Phone  9110380460  
Fax    
Email  nsrividya@sssihl.edu.in  
 
Source of Monetary or Material Support  
Department of Food and Nutritional Sciences Sri Sathya Sai Institute of Higher Learning (Deemed to be University) Vijayanagar Colony Bangalore Highways Near RDT Office Anantapur Andhra Pradesh - 515001 India 
 
Primary Sponsor  
Name  Sri Sathya Sai Institute of Higher Learning 
Address  Sri Sathya Sai Institute of Higher Learning Anantapur Andhra Pradesh - 515001 
Type of Sponsor  Other [Educational Institution (Deemed to be University)] 
 
Details of Secondary Sponsor  
Name  Address 
Prof N Srividya  Department of Food and Nutritional Sciences Sri Sathya Sai Institute of Higher Learning Anantapur Andhra Pradesh - 515001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof N Srividya  Sri Sathya Sai Institute of Higher Learning  Room no.13 Department of Food and Nutritional Sciences Sri Sathya Sai Institute of Higher Learning Vijayanagar Colony Bangalore Highways Near RDT Office
Anantapur
ANDHRA PRADESH 
9110380460

nsrividya@sssihl.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sathya Sai Institute of Higher Learning Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Obesity 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dietary intervention  Reformulated traditional Indian mixed meals suitable for obese people with diabetes risk. It consists of dosa, spiced pulse mix as an accompaniment and a health-beverage prepared with pigmented rice, pulses, nuts and seeds. All the ingredients carefully chosen are commonly consumed and are scientifically proven to aid in blood glucose and insulin management. The total duration including control, intervention and wash out period is planned to be 7 days. 
Comparator Agent  Dietary intervention  Traditional Indian mixed meal. It consists of dosa, spiced pulse mix and a health-beverage prepared with cereals, nuts and seeds. All the ingredients are commonly consumed in day to day meals.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  BMI: 23.5-30 kg/m 2.
Overweight/Obese individuals.
Fasting blood glucose: 70-100 mg/dl.
Freely consented to participate in the study.
 
 
ExclusionCriteria 
Details  Subjects taking medication known to modify glucose metabolism.
Subjects suffering from any illness or food allergies.
Subjects with consumption of any appetite suppressants, weight loss medication, or any other medication that could influence study outcomes
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Effect of plant-based reformulated diabetic friendly Indian traditional mixed meals on Glycemic response and insulinemic responses will be known   Finger prick capillary blood samples will be taken before consumption of the meals, followed by testing every 30 minutes for the next two hours. Intravenous blood will be collected to measure the fasting and post-prandial insulin levels 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of plant-based reformulated diabetic friendly Indian traditional mixed meals on satiety will be known   Participants will be given 20 minutes to complete the meal. Outcome is measured at 0, 10 & 20 minutes.
Subjects rate their feeling of fullness/hunger before meal consumption (0 %) and
after 50 % & 100 % consumption of the control & test meal using the bidirectional SLIM scale.
 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   02/02/2026 
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)  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  

Diabetes mellitus is a major public health problem worldwide affecting millions of people which is essentially due to dramatic changes in diet and lifestyle. It is a chronic disorder occurring due to elevated blood glucose levels and the inability of a body’s response to high blood glucose, which is caused by defects in insulin secretion and action. One of the major aims of chronic disease therapy is to normalize the blood glucose profile, including the fasting and postprandial blood glucose concentrations. Many carbohydrate foods provoke variable glycemic responses. Assessment of glycemic response is one of the effective methods to compare between various meal types.  Low glycemic foods and diets have been shown to improve glycemic control in diabetics and in non-diabetic subjects. The purpose of this study is to evaluate the glycemic and response, insulinemic response and satiety of plant-based diabetic-friendly Indian traditional mixed meals in overweight/obese women. The impact of mixed meals on the post prandial blood glucose response will be determined using finger prick capillary method (Hemocue 201) at 0, 30, 60, 90, 120 minutes. Intravenous blood will be collected to measure the fasting and post-prandial insulin levels. Satiety of the meals will also be evaluated using SLIM scale. Glycemic and insulinemic responses of reformulated traditional meals with diabetic-friendly ingredients will be known from the study results. Better control of diabetes and other lifestyle disorders expected, when results are shared with the general public.

 
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