FindTrial
Sign In

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

A double blind, randomized, crossover, standard-controlled study to determine effect of Loaf Bread + GI-Ctrl on postprandial glucose level - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089014
Enrollment
40
Registered
2025-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: 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 Contr

Sponsors

ProClin Research Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

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)].

Design outcomes

Primary

MeasureTime frame
Incremental change in blood glucose (iAUC) after standard meal consumptionTimepoint: 16 days—

Secondary

MeasureTime frame
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. Timepoint: 16 days—

Countries

India

Contacts

Public ContactDr Mukul Maurya

ProClin Research Pvt Ltd

navonil.sau@proclinresearch.com9051064041

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026