| CTRI Number |
CTRI/2025/12/099520 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Standardized Diet ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How Different People Respond After Eating the Same Meal: A Study of Post-Meal Blood Sugar Changes |
|
Scientific Title of Study
|
Inter-Individual Difference in Postprandial Response to Uniform Diet Study |
| Trial Acronym |
INDIRES |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanketh V Sharma |
| Designation |
Assistant Professor |
| Affiliation |
The University of Trans-Disciplinary Health Sciences and Technology |
| Address |
Department of Ayurveda Biology and Holistic Nutrition,
The University of Trans-Disciplinary Health Sciences and Technology
74/2, Post Attur via Yelahanka, Jarakabande Kaval, Bengaluru, Karnataka
Bangalore
KARNATAKA
560119
India |
| Phone |
9916556229 |
| Fax |
|
| Email |
sanketsharma@tdu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasan Shankar |
| Designation |
Medical Director |
| Affiliation |
Institute of Ayurveda and Integrative Medicine (I-AIM) |
| Address |
Department of Jaratantra,
Institute of Ayurveda and Integrative Medicine (I-AIM)
74/2, Jarakabande kaval, Behind CRPF Camp Attur post, Ramagondanahalli, Bengaluru, Karnataka
Bangalore
KARNATAKA
560119
India |
| Phone |
9945426118 |
| Fax |
|
| Email |
prasan.shankar@iaimhealthcare.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasan Shankar |
| Designation |
Medical Director |
| Affiliation |
Institute of Ayurveda and Integrative Medicine (I-AIM) |
| Address |
Department of Jaratantra,
Institute of Ayurveda and Integrative Medicine (I-AIM)
74/2, Jarakabande kaval, Behind CRPF Camp Attur post, Ramagondanahalli, Bengaluru, Karnataka
Bangalore
KARNATAKA
560119
India |
| Phone |
9945426118 |
| Fax |
|
| Email |
prasan.shankar@iaimhealthcare.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SKAN Research Trust |
| Address |
#747, 18th Main, 6th Block, Koramangala, Bengaluru - 560095
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanketh V Sharma |
Institute of Ayurveda and Integrative Medicine (IAIM), Bengaluru |
Department of Jaratantra,
Institute of Ayurveda and Integrative Medicine (IAIM),
74/2, Jarakabande kaval, Behind CRPF Camp Attur post, Ramagondanahalli, Bengaluru,
Bangalore
KARNATAKA |
9916556229
sanketsharma@tdu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The University of Trans-Disciplinary Health Sciences and Technology, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
BMI between 18 and 25 kg/m2
HbA1C less than 5.7 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Standardized Meal |
Meal 1. Metabolic Challenge Meal: high fat, low carbohydrate Paratha and curd
Meal 2. Medium Fat & Carb: average level of fat and carbohydrate Paratha and curd
Meal 3. High Fat 1: high fat, low carbohydrate paratha
Meal 4. High Carb: high carbohydrate, low fat paratha
OGTT: oral glucose tolerance test (liquid high carbohydrate drink)
Meal 5. High Fiber: high fiber meal consisting of paratha and curd.
Meal 6. High Fat 2: high fat, low carbohydrate paratha.
Meal 7. High Protein: high protein meal consisting of paratha.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
BMI between 18 and 25
HbA1c less than 5.7
Hb level more than 12 and 13 for males and females respectively |
|
| ExclusionCriteria |
| Details |
Allergic to planned meal (paratha and curd).
Any volunteer claiming to be diagnosed with any non-communicable diseases / chronic illness or auto immune disorders
Unable to fast from 9 pm until 9 am on the clinic day.
Use of PPIs (such as omeprazole and pantoprazole) in the last two weeks
Use of antibiotics in the last one month
Pregnancy and lactation
Unable to wear the CGM (Continuous Glucose Monitoring Device) on their arm during the study, e.g. because their profession prohibits it at work |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant inter-individual variations in postprandial responses (glucose, insulin, lipids, and other metabolites) to the challenge meals. |
On the first day of intervention blood samples will be collected on empty stomach, as well as at different time points, CGM (Continuous glucose monitoring device) will be inserted (Which shall remain with him/her for 14 days) questionnaires will be administered.
From day 2 to day 14 CGM (Continuous glucose monitoring device) values are recorded.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between Prakriti (Vata/Pitta/Kapha doshas) & postprandial glucose/insulin. |
On the first day of intervention blood samples will be collected on empty stomach, as well as at different time points, CGM (Continuous glucose monitoring device) will be inserted (Which shall remain with him/her for 14 days) questionnaires will be administered.
From day 2 to day 14 CGM (Continuous glucose monitoring device) values are recorded.
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/01/2026 |
| 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="1"
Months="6"
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
|
Background People show large differences in blood glucose after eating the same food. This variation is influenced by genetics, microbiome, lifestyle, and body composition. Most research is Western; Indian diets and Ayurvedic concepts like Prakriti may affect responses differently. Hypothesis Postprandial glucose responses vary widely between individuals and are influenced by microbiome, Prakriti, Agni, and host factors. Aim To measure inter-individual variation in post-meal glucose responses in an Indian population and relate it to microbiome and Prakriti. Objectives Assess glucose responses to standardized meals. Correlate responses with microbiome and Ayurvedic parameters. Methodology (Very Short) Single-arm study (150 adults, 18–50 years). Participants undergo 14 days of CGM, seven standardized test meals, OGTT, blood sampling (glucose, insulin, TG, biomarkers), Prakriti assessment, and stool microbiome analysis. |