Study designed to test how eating loaf bread along with GI-Ctrl affects blood sugar levels

Not yet recruiting

Conditions: Type 2 diabetes mellitus with unspecified complications,

Registration Number: CTRI/2025/06/089014

Lead Sponsor: ProClin Research Private Limited

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

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
Incremental change in blood glucose (iAUC) after standard meal consumption	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