| CTRI Number |
CTRI/2025/06/089013 [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 Millet 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 Millet Flour+ GI-Ctrl on postprandial glucose level |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PRPL-MTFR-02-2025, 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 |
Millet 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 |
Millet 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
|
Type 2 diabetes is becoming increasingly prevalent worldwide, with a particularly high impact in India. This growing burden underscores the urgent need for cost-effective dietary strategies to manage postprandial blood glucose levels. While metformin remains effective in glycemic control, it often falls short for overweight and obese individuals who face heightened risks of cardiovascular and microvascular complications. Although low glycemic index (GI) diets form a cornerstone of diabetes management, many traditional wheat-based foods still cause significant glucose spikes. Millets, known for their naturally low GI and high fiber content, present a promising alternative for managing glycemic response. However, their efficacy can vary depending on preparation methods and individual metabolic differences. This study explores a novel food formulation that combines millet flour with glycemic index-lowering agents (GI-Ctrl) to enhance postprandial glucose control in high-risk populations. Postprandial glucose responses are assessed using incremental area under the curve (iAUC), a reliable indicator that captures both the magnitude and duration of glucose elevation. The test formulation—millet flour enhanced with GI-Ctrl agents such as resistant starch and soluble fibers—is designed to slow carbohydrate digestion and absorption, thereby improving glycemic response compared to standard millet flour. To evaluate the physiological impact of this intervention, additional markers such as maximum glucose concentration (Cmax) and time to reach this peak (Tmax) are analyzed. These parameters offer deeper insights into glucose metabolism and its regulation.The study targets individuals with diabetes, particularly those who are overweight or obese, due to their increased risk of dysglycemia. These individuals typically exhibit exaggerated postprandial glucose spikes and slower glucose clearance, contributing to insulin resistance and impaired beta cell function. A double-blind, randomized crossover design is employed to ensure robust and unbiased results, accounting for inter-individual variability. Real-time glucose monitoring through continuous glucose monitors (CGMs) allows for precise measurement of glycemic fluctuations following test and control product consumption. In addition to glycemic outcomes, the study evaluates the safety and tolerability of the GI-Ctrl-enhanced formulation, as certain components may affect gastrointestinal health in some individuals. Ultimately, this research aims to provide evidence supporting the integration of Millet Flour + GI-Ctrl into dietary guidelines for diabetes management. The goal is to bridge traditional dietary habits with modern nutritional science, delivering a culturally relevant and scientifically validated solution for improving glycemic control in vulnerable populations. |