NCT07699250

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
Last Updated

July 13, 2026

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

June 28, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

Foxtail Flourmuffinshealth benefits

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 COMPARATOR

50g Wheat based (Muffin) along with their regular diet only per day for 12 weeks

Dietary Supplement: T0

T1

EXPERIMENTAL

one 50g Foxtail millet (Muffin) along with their low glycemic index diet, ONCE A DAY for 12 weeks

Dietary Supplement: T1

T2

EXPERIMENTAL

one 50g Foxtail millet (Muffin) along with their low glycemic index diet, TWICE A DAY for 12 weeks

Dietary Supplement: T2

Interventions

T0DIETARY_SUPPLEMENT

50g Wheat based (Muffin) along with their regular diet

T0
T1DIETARY_SUPPLEMENT

50g Foxtail millet (Muffin) along with their low glycemic index diet ONCE A DAY

T1
T2DIETARY_SUPPLEMENT

50g Foxtail millet (Muffin) along with their low glycemic index diet, TWICE A DAY

T2

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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

Locations