Study designed to test how eating Millet Flour along with GI-Ctrl affects blood sugar levels

Not yet recruiting

Conditions: Type 2 diabetes mellitus with unspecified complications,

Registration Number: CTRI/2025/06/089013

Lead Sponsor: ProClin Research Private Limited

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Subjects with limited physical activity 2.
BMI: 25 to 45 Kg/m2 3.
Subjects taking stable medicine dose for past 3 months.
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.

Exclusion Criteria

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)].

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Jeevandan Multicare Hospital
🇮🇳
Bhopal, MADHYA PRADESH, India
Jeevandan Multicare Hospital
🇮🇳Bhopal, MADHYA PRADESH, India
Dr Kuldeep Katariya
Principal investigator
7777888008
kuldeepkatariya3@gmail.com