A Study to See if a Millet-Based Food Helps Control Blood Sugar and Improve Nutrition in People with Type 2 Diabetes

A Randomized Controlled Clinical Trial Evaluating the Efficacy of a Millet-Based Formulation on Glycemic Regulation and Nutritional Status in Patients with Type 2 Diabetes Mellitus - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094780

Enrollment

Registered

2025-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Millet-Based Formulation: The intervention consists of a ready-to-eat Little Millet Upma Mix, developed as a nutritional/food product in the form of a packed, rehydratable functional fo

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 30 70 years Diagnosed with Type 2 Diabetes Mellitus (as per ADA 2023 guidelines) HbA1c between 6.5% and 9.0% On stable oral hypoglycemic agents for at least 3 months Willing to replace dinner with study formulation Provided written informed consent

Exclusion criteria

Exclusion criteria: Insulin-dependent diabetics Chronic liver, kidney, thyroid dysfunction or cardiac diseases History of gastrointestinal disorders Allergy to millets or cereal grains Pregnant or lactating women Participation in other clinical trials in the last 3 months

Design outcomes

Primary

Measure	Time frame
Change in HbA1c, FBS, PPBS, and OGTT response Change in vitamins (A, B2, B6, B12, D3) and microminerals (Magnesium, Calcium, Zinc, Phosphorus, Manganese, Copper, Selenium)Timepoint: Baseline (0th day) and Day 90	—

Secondary

Measure	Time frame
Change in Liver Function Tests (LFT), Renal Function Tests (RFT), and Lipid profile (TC, LDL, HDL, TG) Change in hematological profile (CBC) and Quality of Life (QOL) using a validated diabetes-specific QOL scaleTimepoint: Baseline (oth day) and Day 90	—

Countries

India

Contacts

Public ContactDr Vijaya R

Pankajakasthuri Ayurveda Medical College and PG Centre

vijivijayan5225@gmail.com6238651628

Outcome results

None listed

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