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CTRI Number  CTRI/2025/10/096293 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 17/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect of Barnyard Millet-Based Functional Foods Enriched with Plant Ingredients on Blood Sugar Levels in Healthy Adults 
Scientific Title of Study   Postprandial Glycaemic Response to Barnyard Millet Functional Foods Fortified with Plant-Based Functional Phytochemicals: A Randomized Crossover Trial in Healthy Adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CRGC/CT/03-2025, Version 1.0 Dated 13.07.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhusudan C 
Designation  Consultant Physician  
Affiliation  NRR Hospital 
Address  OPD consultation Room No 2, Ground floor NRR Hospital Chikkabanavara Hesaragatta Main Road, Bangalore

Bangalore
KARNATAKA
560090
India 
Phone  7022247227  
Fax    
Email  drmadhusudanmadhu123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Cheryl S Raj 
Designation  Student 
Affiliation  NRR Hospital 
Address  Eberly College of Science, The Pennsylvania State University, University Park, Pennsylvania 16802, USA
NRR Hospital Chikkabanavara Hesaragatta Main Road, Bangalore
Bangalore
KARNATAKA
16802
India 
Phone  919731518867  
Fax    
Email  cheryl.07sraj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Madhusudan C 
Designation  Consultant Physician  
Affiliation  NRR Hospital 
Address  OPD consultation Room No 2, Ground floor NRR Hospital Chikkabanavara Hesaragatta Main Road, Bangalore

Bangalore
KARNATAKA
560090
India 
Phone  7022247227  
Fax    
Email  drmadhusudanmadhu123@gmail.com  
 
Source of Monetary or Material Support  
CLINISYD Research Global Solutions Pvt Ltd Ground floor, #49 2nd cross, Mallasndra Main Road, Shettyhalli. Jalahalli west, Bangalore 560015, Karnataka, India 
 
Primary Sponsor  
Name  CLINISYD Research Global Solutions Pvt Ltd 
Address  ground floor, #49 2nd cross, Mallasndra Main Road, shettyhalli. Jalahalli west, Bangalore 56015 
Type of Sponsor  Contract research organization 
 
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 
DrMadhusudanC  Dr.Madhusudan.C  OPD consultation Room No2, Ground floor NRR Hospital Chikkabanavara Hesaragatta Main Road,Bangalore-560090
Bangalore
KARNATAKA 		 7022247227

drmadhusudanmadhu123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Asha Hospitals Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Glucose  25 g of Glucose in 200 ml water will be given orally to the subjects twice in the Study 
Intervention  Test Product 1-BM  Equivalent to 25 g of available carbohydrate, served with 200 ml of water to the Subject once in the Study  
Intervention  Test Product 2-BMM  Equivalent to 25 g of available carbohydrate and 1.5 g of Plant-Based Functional Phytochemicals served with 200 ml of water to the Subject once in the Study  
Intervention  Test Product 3-BMF  Equivalent to 25 g of available carbohydrate and 1.5 g of Plant-Based Functional Phytochemicals served with 200 ml of water to the Subject once in the Study 
Intervention  Test Product 4-BMC  Equivalent to 25 g of available carbohydrate and 1.5 g of Plant-Based Functional Phytochemicals served with 200 ml of water to the Subject once in the Study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Healthy adults (based on medical history and screening tests) in the age group of 18 and 45 years – subjects
2.Fasting blood glucose levels less than or equal to 100mg/dL.
3.Glycosylated Hemoglobin (HbA1c) less than or equal to 100mg/dL. 5.6 as per American Diabetes Association (ADA)
4.BMI should be between 18.5 to 25 kg/m2
5.HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) less than or equal to 100mg/dL.2.5 as per American Diabetes Association (ADA)
6.Lipid profile (Total cholesterol) within normal range as applicable
7.Must be willing to give written informed consent and comply with the study procedures.
8.Subject’s complete blood count parameters to be within clinically acceptable range by Investigator.
9.Willing to abstain from other functional foods or supplements during the study
10.Not currently on any medication or supplement affecting glucose, lipid, or weight metabolism
 
 
ExclusionCriteria 
Details  1.Subjects particularly on any special diet
2.Subjects suffering from any systemic disorders (diabetes mellitus, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases) or severe food allergies; an active infectious disease (HBV, HCV, HIV)
3.current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders
4.Patient having participated in any other clinical trial within one month prior to screening
5.Current use of Use of medications or supplements that affect outcomes
6.Allergy or intolerance to millets, cereals, fenugreek, cinnamon, moringa, or any study ingredients
7.Any other medical condition or circumstance that, in the investigator’s judgment, would make participation unsafe.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess glycemic index using blood sugar levels   To assess glycemic index using blood sugar levels of test products measured at fixed intervals (-5, 15, 30, 45, 60, 90 and 120 min 
 
Secondary Outcome  
Outcome  TimePoints 
Glycaemic Index(GI) of the test product assessing C-peptide levels   at -5min and after 120 min  
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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)   19/11/2025 
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="6"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
The glycemic index (GI) is a measure of the blood glucose-raising potential of the Carbohydratecontent of a food compared to a reference food
(generally pure glucose) (https://lpi.oregonstate.edu/mic/food-beverages/glycemic-index-glycemic-load). It is measured in a scale of 0-100 where below 55 is considered as lowglycemic index, 56- 69 as medium glycemic index and 70 and above as high glycemic index.Foods that have refined sugar contents have generally more glycemic index and might affectthe
blood sugar levels whereas foods with typically less sugar and more fibre have less glycemicindex. Subjects who fulfil the eligibility criteria will be enrolled in the study after
signing the informed consent form. Present study is aimed to evaluate the glycemic index of Four food products

 
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