Tip 2 Diabetes MellitusNCT07833527
Effect of Proso Millet-Based Bread on Postprandial Glycemic Response in Adults With Type 2 Diabetes
A study testing Proso Millet-Based Bread and White Wheat Bread in people with Tip 2 Diabetes Mellitus, run by Gazi University.
Trial summary
This randomized, double-blind, crossover clinical study aims to evaluate the acute effect of proso millet-based bread on postprandial glycemic response in adults with type 2 diabetes. A total of 52 participants are planned to be enrolled. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Tip 2 Diabetes Mellitus
- What is being tested?
- Proso Millet-Based Bread and White Wheat Bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 35 and 60 years Body mass index (BMI) ≥18.5 and ≤39.99 kg/m² Diagnosed with type 2 diabetes mellitus for at least 1 year Stable doses of antidiabetic medications for at least 3 months Cognitively capable of following dietary records and study instructions
Who cannot join
- Presence of atherosclerotic cardiovascular disease Malignancy Gastrointestinal disease Psychiatric disease Use of vitamin, mineral, or nutritional supplements Food allergy Following a weight-loss diet within the previous 3 months Regular consumption of millet (proso millet) Use of medications affecting carbohydrate metabolism Insulin therapy History of alcohol or substance dependence Major surgery within the previous 6 months Thyroid disease, including hypothyroidism or hyperthyroidism Engagement in high-intensity physical activity (e.g., professional athletes) Habitual consumption of a high-fiber diet Sleep disorder or night-shift work Antibiotic treatment Blood transfusion within the previous 3 months Presence of other endocrine disorders that may affect glucose metabolism Inability or unwillingness to comply with the study protocol Fasting capillary blood glucose at 0 minutes <70 mg/dL or >150 mg/dL, or HbA1c >7.5% Heavy exercise within the previous 48 hours Current infection Smoking or alcohol consumption before the test session Caffeine consumption within the previous 24 hours Acute stress Use of medications that may affect blood glucose, such as corticosteroids or beta-blockers
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of a Proso Millet-Based Bread Formulation and Investigation of Its Effect on Glycemic Response in Patients With Diabetes
This randomized, double-blind, crossover clinical study aims to evaluate the acute effect of proso millet-based bread on postprandial glycemic response in adults with type 2 diabetes. A total of 52 participants are planned to be enrolled.
Each participant will attend two test sessions and will consume proso millet-based bread in one session and white wheat bread in the other. The order of the test breads will be randomized, and the two sessions will be separated by a one-week washout period. Each bread portion will provide 50 g of available carbohydrate.
Read more
During each test session, the bread will be consumed within 10 minutes with 250 mL of water. Capillary blood glucose concentrations will be measured at predefined time points from baseline to 180 minutes after the start of consumption. Postprandial glycemic response will primarily be evaluated using the incremental area under the glucose response curve (iAUC).
The study will investigate whether the postprandial glycemic response following consumption of proso millet-based bread differs from that following consumption of white wheat bread in adults with type 2 diabetes.
Read the detailed description
This is a randomized, double-blind, two-period crossover clinical study designed to evaluate the acute postprandial glycemic response to proso millet-based bread compared with white wheat bread in adults with type 2 diabetes.
Prior to the clinical phase, different proso millet-based bread formulations will be evaluated for sensory and physical characteristics. The formulation with the highest overall acceptability and appropriate structural characteristics will be selected as the investigational bread for the clinical phase. Texture profile analysis will be performed for quality-control purposes on the selected proso millet-based bread and the white wheat bread.
In the clinical phase, participants will undergo two test sessions in randomized order. Each participant will receive both interventions and therefore serve as their own control. The two sessions will be separated by a one-week washout period.
The investigational intervention will consist of the selected proso millet-based bread, and the comparator intervention will consist of white wheat bread. Portions will be standardized to provide 50 g of available carbohydrate, calculated as total carbohydrate minus dietary fiber. Test products will be presented using coded identifiers to maintain blinding of participants and investigators.
At each test session, participants will consume the assigned bread within 10 minutes together with 250 mL of water. Timing will begin with the first bite. Capillary blood glucose will be measured at 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes. Postprandial glucose response will be evaluated using the incremental area under the glucose response curve calculated by the trapezoidal method.
Before the test sessions, participant characteristics, health information, dietary habits, physical activity, dietary intake, anthropometric measurements, and body composition will be assessed. These data will be used to characterize the study population and support the evaluation of the clinical findings.
- Conditions
- Tip 2 Diabetes Mellitus
- Being tested
- Proso Millet-Based Bread, White Wheat Bread
- Keywords
- Glycemic Response, Type 2 Diabetes Mellitus, Proso Millet, Millet-Based Bread, Postprandial Blood Glucose
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proso Millet-Based BreadOther
Participants will consume a portion of proso millet-based bread providing 50 g of available carbohydrate (total carbohydrate minus dietary fiber) within 10 minutes, accompanied by 250 mL of water.
White Wheat BreadOther
Participants will consume a portion of white wheat bread providing 50 g of available carbohydrate (total carbohydrate minus dietary fiber) within 10 minutes, accompanied by 250 mL of water.
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB | Experimental | Participants will receive proso millet-based bread in the first intervention session, followed by white wheat bread in the second intervention session after a one-week washout period. Receives: Other: Proso Millet-Based Bread; Other: White Wheat Bread |
| Sequence BA | Experimental | Participants will receive white wheat bread in the first intervention session, followed by proso millet-based bread in the second intervention session after a one-week washout period. Receives: Other: Proso Millet-Based Bread; Other: White Wheat Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Area Under the Curve (iAUC) for Postprandial Blood Glucose
The incremental area under the curve (iAUC) for capillary blood glucose will be calculated using the trapezoidal method based on glucose concentrations measured at 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes after consumption of each test bread. The iAUC will be compared between the proso millet-based bread and white wheat bread interventions.
Measured: 0 to 180 minutes after consumption of each test bread
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tip 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will receive both the proso millet-based bread and the white wheat bread in two separate intervention sessions in a randomized order, with a one-week washout period between sessions. Each participant will serve as their own control.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Seyma Sehadet TASDEMIR, Gazi University
- Investigators
- Yasemin AKDEVELİOĞLU, PhD, Study chair, Gazi UniversityMehmet M YALÇIN, PhD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833527
- Sponsor's protocol ID
- 26-AKD-52
- Other IDs
- 126S321
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to participant confidentiality and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Proso Millet-Based Bread Formulation and Investigation of Its Effect on Glycemic Response in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT07833527
- Acronym / sponsor ID
- 26-AKD-52
- Conditions
- Tip 2 Diabetes Mellitus
- Keywords
- Glycemic Response, Type 2 Diabetes Mellitus, Proso Millet, Millet-Based Bread, Postprandial Blood Glucose
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Sep 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, double-blind, crossover clinical study aims to evaluate the acute effect of proso millet-based bread on postprandial glycemic response in adults with type 2 diabetes. A total of 52 participants are planned to be enrolled.
Each participant will attend two test sessions and will consume proso millet-based bread in one session and white wheat bread in the other. The order of the test breads will be randomized, and the two sessions will be separated by a one-week washout period. Each bread portion will provide 50 g of available carbohydrate.
During each test session, the bread will be consumed within 10 minutes with 250 mL of water. Capillary blood glucose concentrations will be measured at predefined time points from baseline to 180 minutes after the start of consumption. Postprandial glycemic response will primarily be evaluated using the incremental area under the glucose response curve (iAUC).
The study will investigate whether the postprandial glycemic response following consumption of proso millet-based bread differs from that following consumption of white wheat bread in adults with type 2 diabetes.
Detailed description
This is a randomized, double-blind, two-period crossover clinical study designed to evaluate the acute postprandial glycemic response to proso millet-based bread compared with white wheat bread in adults with type 2 diabetes.
Prior to the clinical phase, different proso millet-based bread formulations will be evaluated for sensory and physical characteristics. The formulation with the highest overall acceptability and appropriate structural characteristics will be selected as the investigational bread for the clinical phase. Texture profile analysis will be performed for quality-control purposes on the selected proso millet-based bread and the white wheat bread.
In the clinical phase, participants will undergo two test sessions in randomized order. Each participant will receive both interventions and therefore serve as their own control. The two sessions will be separated by a one-week washout period.
The investigational intervention will consist of the selected proso millet-based bread, and the comparator intervention will consist of white wheat bread. Portions will be standardized to provide 50 g of available carbohydrate, calculated as total carbohydrate minus dietary fiber. Test products will be presented using coded identifiers to maintain blinding of participants and investigators.
At each test session, participants will consume the assigned bread within 10 minutes together with 250 mL of water. Timing will begin with the first bite. Capillary blood glucose will be measured at 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes. Postprandial glucose response will be evaluated using the incremental area under the glucose response curve calculated by the trapezoidal method.
Before the test sessions, participant characteristics, health information, dietary habits, physical activity, dietary intake, anthropometric measurements, and body composition will be assessed. These data will be used to characterize the study population and support the evaluation of the clinical findings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will receive both the proso millet-based bread and the white wheat bread in two separate intervention sessions in a randomized order, with a one-week washout period between sessions. Each participant will serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Sequence AB | Experimental | Other: Proso Millet-Based Bread, Other: White Wheat BreadParticipants will receive proso millet-based bread in the first intervention session, followed by white wheat bread in the second intervention session after a one-week washout period. |
| Sequence BA | Experimental | Other: Proso Millet-Based Bread, Other: White Wheat BreadParticipants will receive white wheat bread in the first intervention session, followed by proso millet-based bread in the second intervention session after a one-week washout period. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 35 and 60 years Body mass index (BMI) ≥18.5 and ≤39.99 kg/m² Diagnosed with type 2 diabetes mellitus for at least 1 year Stable doses of antidiabetic medications for at least 3 months Cognitively capable of following dietary records and study instructions
Key exclusion criteria (1 listed)
- Presence of atherosclerotic cardiovascular disease Malignancy Gastrointestinal disease Psychiatric disease Use of vitamin, mineral, or nutritional supplements Food allergy Following a weight-loss diet within the previous 3 months Regular consumption of millet (proso millet) Use of medications affecting carbohydrate metabolism Insulin therapy History of alcohol or substance dependence Major surgery within the previous 6 months Thyroid disease, including hypothyroidism or hyperthyroidism Engagement in high-intensity physical activity (e.g., professional athletes) Habitual consumption of a high-fiber diet Sleep disorder or night-shift work Antibiotic treatment Blood transfusion within the previous 3 months Presence of other endocrine disorders that may affect glucose metabolism Inability or unwillingness to comply with the study protocol Fasting capillary blood glucose at 0 minutes <70 mg/dL or >150 mg/dL, or HbA1c >7.5% Heavy exercise within the previous 48 hours Current infection Smoking or alcohol consumption before the test session Caffeine consumption within the previous 24 hours Acute stress Use of medications that may affect blood glucose, such as corticosteroids or beta-blockers
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 |
|---|---|---|
| Proso Millet-Based BreadParticipants will consume a portion of proso millet-based bread providing 50 g of available carbohydrate (total carbohydrate minus dietary fiber) within 10 minutes, accompanied by 250 mL of water. | Other | Sequence AB, Sequence BA |
| White Wheat BreadParticipants will consume a portion of white wheat bread providing 50 g of available carbohydrate (total carbohydrate minus dietary fiber) within 10 minutes, accompanied by 250 mL of water. | Other | Sequence AB, Sequence BA |
Primary outcome
Incremental Area Under the Curve (iAUC) for Postprandial Blood Glucose
Time frame: 0 to 180 minutes after consumption of each test bread
The incremental area under the curve (iAUC) for capillary blood glucose will be calculated using the trapezoidal method based on glucose concentrations measured at 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes after consumption of each test bread. The iAUC will be compared between the proso millet-based bread and white wheat bread interventions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to participant confidentiality and data protection considerations.
Related trials for Tip 2 Diabetes Mellitus
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Not yet recruiting
Evaluation of the Effect of Nurse Coaching Program on Self-management and Skin Care Behaviors in Patients With Diabetes
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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.
Yasemin AKDEVELİOĞLU, PhD study chair
Gazi University
Mehmet M YALÇIN, PhD principal investigator
Gazi University
Questions about this trial
What is this clinical trial studying?
A study testing Proso Millet-Based Bread and White Wheat Bread in people with Tip 2 Diabetes Mellitus, run by Gazi University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Şeyma Ş TAŞDEMİR, Research Assistant/PhD Student (+90 541 830 2166, sehadettasdemir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Area Under the Curve (iAUC) for Postprandial Blood Glucose (time frame: 0 to 180 minutes after consumption of each test bread). 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 22 Sep 2026.