Foxtail Millet Based Dietary Intervention for Postprandial Glycemic Management Among Obese Diabetic Patients
1 other identifier
interventional
102
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Apr 2025
Shorter than P25 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2025
CompletedFirst Submitted
Initial submission to the registry
June 28, 2026
CompletedFirst Posted
Study publicly available on registry
July 13, 2026
CompletedJuly 13, 2026
April 1, 2025
4 months
June 28, 2026
July 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DIABETES, lipid profile, weight, liver enzymes
fasting glucose, HbA1c weight, lipid profile and LFT were checked on baseline and on 12 week of the study
12 WEEK
Study Arms (3)
T0
PLACEBO COMPARATOR50g Wheat based (Muffin) along with their regular diet only per day for 12 weeks
T1
EXPERIMENTALone 50g Foxtail millet (Muffin) along with their low glycemic index diet, ONCE A DAY for 12 weeks
T2
EXPERIMENTALone 50g Foxtail millet (Muffin) along with their low glycemic index diet, TWICE A DAY for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sana Noreen
Lahore, Punjab Province, 54000, Pakistan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2026
First Posted
July 13, 2026
Study Start
April 10, 2025
Primary Completion
July 25, 2025
Study Completion
July 25, 2025
Last Updated
July 13, 2026
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share