DiabetesNCT07699250
Foxtail Millet Based Dietary Intervention for Postprandial Glycemic Management Among Obese Diabetic Patients
A study testing T0, T1 and T2 in people with Diabetes and Liver, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Liver, Lipid Profiles
- What is being tested?
- T0, T1 and T2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2025to 25 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes, Liver, Lipid Profiles
- Being tested
- T0, T1, T2
- Keywords
- Foxtail Flour, muffins, health benefits
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T0Dietary supplement
50g Wheat based (Muffin) along with their regular diet
T1Dietary supplement
50g Foxtail millet (Muffin) along with their low glycemic index diet ONCE A DAY
T2Dietary supplement
50g Foxtail millet (Muffin) along with their low glycemic index diet, TWICE A DAY
| Study group | Role | What they receive |
|---|---|---|
| T0 | Placebo comparator | 50g Wheat based (Muffin) along with their regular diet only per day for 12 weeks Receives: Dietary Supplement: T0 |
| T1 | Experimental | one 50g Foxtail millet (Muffin) along with their low glycemic index diet, ONCE A DAY for 12 weeks Receives: Dietary Supplement: T1 |
| T2 | Experimental | one 50g Foxtail millet (Muffin) along with their low glycemic index diet, TWICE A DAY for 12 weeks Receives: Dietary Supplement: T2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 WEEK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start10 Apr 2025
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699250
- Sponsor's protocol ID
- UOL-REG-70173022
- Status last verified
- Apr 2025
- First submitted
- 28 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foxtail Millet Based Dietary Intervention for Postprandial Glycemic Management Among Obese Diabetic Patients
- ClinicalTrials.gov ID
- NCT07699250
- Acronym / sponsor ID
- UOL-REG-70173022
- Conditions
- Diabetes, Liver, Lipid Profiles
- Keywords
- Foxtail Flour, muffins, health benefits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T0 | Placebo comparator | Dietary Supplement: T050g Wheat based (Muffin) along with their regular diet only per day for 12 weeks |
| T1 | Experimental | Dietary Supplement: T1one 50g Foxtail millet (Muffin) along with their low glycemic index diet, ONCE A DAY for 12 weeks |
| T2 | Experimental | Dietary Supplement: T2one 50g Foxtail millet (Muffin) along with their low glycemic index diet, TWICE A DAY for 12 weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T050g Wheat based (Muffin) along with their regular diet | Dietary supplement | T0 |
| T150g Foxtail millet (Muffin) along with their low glycemic index diet ONCE A DAY | Dietary supplement | T1 |
| T250g Foxtail millet (Muffin) along with their low glycemic index diet, TWICE A DAY | Dietary supplement | T2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T0, T1 and T2 in people with Diabetes and Liver, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DIABETES, lipid profile, weight, liver enzymes (time frame: 12 WEEK). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.