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A clinical trial to study the effect of Resistant Starch enriched Cookies in patients with Type 2 Diabetes Mellitus

To assess the impact of a newly formulated Resistant Starch enriched Cookies (RSC) on the metabolic profile of 30 humans with Type 2 Diabetes Mellitus (T2DM) - a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041554
Enrollment
30
Registered
2022-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Cookies: For the trial, out of the total 30 volunteers, 15 volunteers will take 2 cookies (20 g each) once in the morning (7 am) for 14 days. And the rest 15 volunteers will take 2 cook

Sponsors

Professor Rintu Banerjee
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults of both gender with fasting blood sugar more than 150 mg per dl and post prandial blood sugar more than 250 mg per dl 2. Drug naive or patients on monotherapy for treatment of diabetes more than 2 weeks 3. Subjects willing to voluntarily participate in the study by giving their informed consent and willing to follow protocol procedures

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes 2. Gestational Diabetes Mellitus 3. Patient with history of recent MI 4. Patient with acute dyspepsia 5. Known allergy to the product

Design outcomes

Primary

MeasureTime frame
1. Decrease from baseline to study end in: a. Fasting Blood Glucose b. Post-prandial blood glucose levels c. Post prandial Insulin d. Capillary Blood sugarTimepoint: a. Fasting Blood Glucose for 14 days b. Post-prandial blood glucose levels at 120 min post consumption of Resistant Starch enriched Cookies for 14 days c. Post prandial Insulin before the initiation of the study and once after the completion of the 14 days trial d. Capillary Blood sugar taken at 0 min, 30 min, 60 min, 90 min and 120 min post consumption of Resistant Starch enriched Cookies for 14 days

Secondary

MeasureTime frame
1. Decrease in BMI and waist circumference from baseline to improvement end 2. Decrease in triglycerides, low density lipoprotein and increase in high density lipoprotein from baseline to study endTimepoint: Once before the study and once after the completion of the 14 days trial

Countries

India

Contacts

Public ContactMohan Das

Indian Institute of Technology Kharagpur

rintuin@gmail.com9434014609

Outcome results

None listed

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