| 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
|
|
|
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. |