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CTRI Number  CTRI/2025/06/089014 [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 loaf bread along with GI-Ctrl affects blood sugar levels 
Scientific Title of Study   A double blind, randomized, crossover, standard-controlled study to determine effect of Loaf Bread + GI-Ctrl on postprandial glucose level 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PRPL-LFBD-01-2025, 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  Loaf Bread (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  Loaf Bread + 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 
Incremental change in blood glucose (iAUC) after standard meal consumption   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="40"
Sample Size from India="40" 
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 increasing prevalence of type 2 diabetes mellitus (T2DM) and obesity underscores the urgent need for effective dietary interventions to mitigate postprandial hyperglycemia—a key contributor to metabolic disorders. Loaf Bread + GI-Ctrl represents a novel formulation of a common dietary staple, designed to reduce postprandial glucose spikes through the incorporation of glycemic index (GI)-modulating ingredients. When combined with nutrition education, this formulation demonstrated a reduction in postprandial glucose excursions. In contrast, conventional loaf bread, characterized by a high GI, exacerbates hyperglycemia in individuals with diabetes and those who are overweight, making it a clear target for nutritional improvement.
The primary objective of this study was to evaluate the effectiveness of Loaf Bread + GI-Ctrl in reducing postprandial glycemia—measured as the incremental area under the blood glucose curve—in a free-living population. This directly supports the broader goal of improving glycemic control. Secondary outcomes included assessments of maximum glucose concentration (Cmax), time to peak glucose level (Tmax), and tolerability, offering a well-rounded evaluation of the product’s metabolic efficacy and real-world applicability. Continuous glucose monitoring (CGM) provided precise tracking of glucose fluctuations, enabling detailed insight into the glycemic response on an individual basis.
The crossover study design enhanced statistical power by minimizing inter-individual variability, while randomization and double-blinding helped to reduce potential bias. The selected study population—overweight or obese adults with T2DM, maintained on stable metformin therapy and with low physical activity levels—represents a clinically relevant group with a critical need for improved glycemic control. Carefully defined exclusion criteria minimized potential confounders, such as complex comorbidities or use of medications beyond metformin, thereby strengthening the interpretability of the intervention’s effects.
If shown to be safe and effective, the use of Loaf Bread + GI-Ctrl may offer a practical dietary strategy for managing T2DM and obesity. These findings have the potential to influence dietary guidelines, inspire innovation in the functional food sector, and support public health strategies aimed at reducing the metabolic burden associated with these widespread conditions.
 
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