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CTRI Number  CTRI/2025/06/089015 [Registered on: 18/06/2025] Trial Registered Prospectively
Last Modified On: 05/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Study designed to test how eating Wheat Flour along with GI-Ctrl affects blood sugar levels 
Scientific Title of Study   A double blind, randomized, crossover, standard-controlled study to determine effect of Wheat Flour+ GI-Ctrl on postprandial glucose level 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PRPL-WTFR-03-2025, Version 1, 30th May 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kuldeep Katariya 
Designation  Consultant MD  
Affiliation  Jeevandan Multicare Hospital 
Address  Room No. 01, Ground Floor, General Med Dept, Bhel Sangam Chouraha, Danish Nagar, Bagsewaniya

Bhopal
MADHYA PRADESH
462026
India 
Phone  7777888008  
Fax    
Email  Kuldeepkatariya3@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Navonil Sau 
Designation  Sr. Medical Advisor- Clinical Operation 
Affiliation  ProClin Research Pvt Ltd 
Address  Room no 1, 2nd Floor, Plot no 1, Near nevri Mandir, Gufa Mandir Road, Lalghati

Bhopal
MADHYA PRADESH
462030
India 
Phone  9051064041  
Fax    
Email  navonil.sau@proclinresearch.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mukul Maurya 
Designation  Director & Founder 
Affiliation  ProClin Research Pvt Ltd 
Address  Room no 1, 2nd Floor, Plot no 1, Near nevri Mandir, Gufa Mandir Road, Lalghati

Bhopal
MADHYA PRADESH
462030
India 
Phone  7032802286  
Fax    
Email  mukul@proclinresearch.com  
 
Source of Monetary or Material Support  
ProClin Research Private Limited, Plot #1, Nevri Hills Gufa Mandir Road, Lalghati, Bhopal 462001  
 
Primary Sponsor  
Name  ProClin Research Private Limited 
Address  Plot #1, Nevri Hills Gufa Mandir Road, Lalghati, Bhopal 462001 
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 
Dr Kuldeep Katariya  Jeevandan Multicare Hospital  Room no 3, Ground Floor, General Med Dept, Bhel Sangam Colony, Bagsewaniya
Bhopal
MADHYA PRADESH 
7777888008

kuldeepkatariya3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Charak Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Wheat Flour (Routine)  As Per routine dietary intake subjects will be advised to take, Store in a cool, dry place away from direct sunlight and Oral consumption as food for 16 days 
Intervention  Wheat Flour + GI-Ctrl  As Per routine dietary intake subjects will be advised to take, Store in a cool, dry place away from direct sunlight and Oral consumption as food for 16 days 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Subjects with limited physical activity
2. BMI: 25 to 45 Kg/m2
3. Subjects taking stable medicine dose for past 3 months.
4. For diabetic group, subjects who are consuming biguanides (Metformin) for blood glucose control
5. Subjects willing to give written informed consent and adhere to all the requirements of this protocol. 
 
ExclusionCriteria 
Details  1.Pregnant and lactating female.
2.Subjects with BMI More than or equal to 45.
3.Type I diabetic patients
4.Subjects who are taking any sugar control supplements
5.Subjects who are under the DPP-4 inhibitor, incretin mimetic, glucosidase inhibitor, rapid acting/short acting/ intermediate acting and premixed insulin-based treatment.
6.Subject with major chronic complications (including but not limited to) autoimmune disease, inflammation, etc. Subject consuming any drug other than metformin.
7.Organic insufficiency (cardiac, hepatic, renal, respiratory)
8.Chronic smoking and alcohol intake
9.Allergy to the ingredients in the test product.
10.History of any surgery in the past 3 months.
11.Subject currently taking or has in the past 30 days used GI related probiotics/prebiotics or any enzymes [prescription or over the counter (OTC)]. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Postprandial glucose monitoring: Incremental increase in glucose concentration (iAUC) after standard meal consumption, comparison in response among placebo and test.  16 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Determination of maximum glucose concentration (Cmax) after standard meal consumption
2.Evaluation of time required to reach maximum glucose concentration (Tmax) after standard meal consumption
3.Determining safety and tolerability of Test Product with reported discomforts.
 
16 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/06/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 rising prevalence of type 2 diabetes mellitus (T2DM) and its associated complications necessitates effective strategies to manage postprandial hyperglycemia, a key driver of disease progression. As a dietary staple across India and many other regions, wheat flour plays a central role in daily nutrition but has a high glycemic index, contributing to significant post-meal glucose spikes—especially in individuals with diabetes or those who are overweight.

This research explores the potential of modified wheat flour enriched with glycemic control ingredients (GI-Ctrl) to mitigate these spikes, offering a culturally compatible solution for better glycemic management. The study compares the effects of standard wheat flour with Wheat Flour + GI-Ctrl on postprandial glucose responses.

Key outcomes include incremental area under the glucose curve (iAUC), maximum glucose concentration (Cmax), and time to reach Cmax (Tmax), all measured via continuous glucose monitoring (CGM) to capture comprehensive, real-world glucose response patterns. Participants include individuals with T2DM as well as those who are overweight or obese (BMI 25–45 kg/m²), due to their heightened risk for glycemic dysregulation.

A double-blind, randomized crossover design enhances the study’s rigor by minimizing bias and allowing for individualized comparisons. Secondary objectives focus on safety and tolerability, particularly gastrointestinal side effects, to assess the broader feasibility of the intervention. Only stable metformin users are included to isolate the dietary effects without confounding from other glucose-lowering drugs.

Given the global reliance on wheat-based diets, this study has significant public health relevance. Scaling the Wheat Flour + GI-Ctrl intervention could offer an accessible, dietary-based strategy to improve glycemic control and quality of life among at-risk populations.

 
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