| 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
|
|
|
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 |
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. |