| 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
|
|
|
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
|
|
|
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. |