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

July 7, 2026 updated by: University of Lahore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Type 2 diabetes mellitus (T2DM) and obesity are rapidly increasing public health concerns in Pakistan and are strongly associated with unhealthy dietary habits, excess body weight, and sedentary lifestyles. Functional foods with low glycemic properties have gained considerable attention as supportive dietary approaches for improving glycemic control and reducing diabetes-related complications. Foxtail millet (Setaria italica (L.) P. Beauv.) is a nutrient-dense cereal grain rich in dietary fiber, resistant starch, essential minerals, antioxidants, and slowly digestible carbohydrates, making it a promising candidate for glycemic management.

This randomized controlled trial investigated the effects of foxtail millet muffin supplementation on postprandial glycemic response and metabolic health among 102 obese diabetic patients aged 30-60 years. Participants were randomly allocated into three intervention groups for a period of 10 weeks. Group T₀ received a 50 g wheat muffin with their usual diet, Group T₁ received a 50 g foxtail millet muffin once daily, while Group T₂ received a 50 g foxtail millet muffin twice daily in combination with a low glycemic index dietary plan. Baseline and post-intervention assessments included anthropometric measurements, fasting blood glucose (FBG), glycated hemoglobin (HbA1c), lipid profile, and liver function parameters. The nutritional composition and sensory characteristics of the muffins were also evaluated.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Sana Noreen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: T0
50g Wheat based (Muffin) along with their regular diet only per day for 12 weeks
Dietary supplement: T0
50g Wheat based (Muffin) along with their regular diet
Experimental: T1
one 50g Foxtail millet (Muffin) along with their low glycemic index diet, ONCE A DAY for 12 weeks
Dietary supplement: T1
50g Foxtail millet (Muffin) along with their low glycemic index diet ONCE A DAY
Experimental: T2
one 50g Foxtail millet (Muffin) along with their low glycemic index diet, TWICE A DAY for 12 weeks
Dietary supplement: T2
50g Foxtail millet (Muffin) along with their low glycemic index diet, TWICE A DAY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DIABETES, lipid profile, weight, liver enzymes
Time Frame: 12 WEEK
fasting glucose, HbA1c weight, lipid profile and LFT were checked on baseline and on 12 week of the study
12 WEEK

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2025

Primary Completion (Actual)

July 25, 2025

Study Completion (Actual)

July 25, 2025

Study Registration Dates

First Submitted

June 28, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOL-REG-70173022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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