CompletedNot Applicable

Foxtail Millet Based Dietary Intervention for Postprandial Glycemic Management Among Obese Diabetic Patients

Pakistan102 participantsStarted 2025-04-10

Plain-language summary

This randomized controlled trial evaluated the effectiveness of foxtail millet (Setaria italica (L.) P. Beauv.) muffin supplementation on postprandial glycemic management among obese patients with type 2 diabetes mellitus. A total of 102 participants aged 30-60 years were randomly assigned to three groups for 10 weeks: T₀ (50 g wheat muffin with usual diet), T₁ (50 g foxtail millet muffin once daily), and T₂ (50 g foxtail millet muffin twice daily combined with a low glycemic index diet). Anthropometric indices, glycemic markers, lipid profile, and liver function parameters were assessed before and after intervention. The results demonstrated significant improvements in metabolic outcomes, particularly in the T₂ group. Participants receiving foxtail millet muffins twice daily exhibited substantial reductions in body weight, BMI, fasting blood glucose, and HbA1c levels. Significant improvements were also observed in lipid parameters, including decreased total cholesterol, triglycerides, and LDL cholesterol, along with increased HDL cholesterol concentrations. Favorable changes in liver function markers further indicated enhanced metabolic health. Sensory evaluation confirmed good acceptability and palatability of the foxtail millet muffins. Overall, the findings suggest that regular consumption of foxtail millet muffins, especially when combined with a low glycemic index diet, is an effective dietary strategy for improving glycemic control, reducing obesity-related risk factors, and promoting metabolic health in obese diabetic patients.

Who can participate

Age range

30 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:i. Inclusion Criteria * People between 30 to 60 years old * Body Mass Index (BMI) ≥30.0 kg/m² * Fasting blood glucose levels ≥ 7.0 mmol/L (126 mg/dL) * Individuals having HbA1c ≥ 6.5% * Elevated Lipid Profile: TC \> 200 mg/dL, TG \> 150 mg/dL, LDL-C \> 100 mg/dL, HDL-C \< 40 mg/dL (men) / \< 50 mg/dL (women) * Elevated Liver Function Tests: ALT \> 56 U/L, AST \> 40 U/L, ALP \> 147 U/L, Total Bilirubin \> 1.2 mg/dL, Albumin \< 3.5 g/dL ii. Exclusion Criteria * Individuals who have a known allergy or have experienced any adverse reaction to foxtail millet or any of the ingredients used in the muffins will not be included in the study * Patients who are taking medications known to significantly alter glucose metabolism or gastrointestinal absorption * Individuals who have recently had gastric surgery or who have surgery planned during the research period * Presence of other severe chronic diseases (e.g., severe renal, hepatic, or cardiovascular disease, active cancer) * Nursing or pregnant females

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

DIABETES, lipid profile, weight, liver enzymes

Timeframe: 12 WEEK

Trial details

NCT IDNCT07699250

SponsorUniversity of Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-25

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