[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657094":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":23,"studyPopulation":13,"armGroups":24,"interventions":36,"overallOfficials":45,"centralContacts":52,"locations":13,"responsibleParty":58,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":13,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":13,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":89,"whyStopped":13,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":13},{"fullName":5,"class":6},"Gazi University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"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.","0 to 180 minutes after consumption of each test bread",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":6,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","CROSSOVER","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":19,"maskingDescription":13,"whoMasked":20},"DOUBLE",[21,22],"PARTICIPANT","INVESTIGATOR","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.\n\nPrior 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.\n\nIn 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.\n\nThe 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.\n\nAt 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.\n\nBefore 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.",[25,32],{"label":26,"type":27,"description":28,"interventionNames":29},"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.",[30,31],"Other: Proso Millet-Based Bread","Other: White Wheat Bread",{"label":33,"type":27,"description":34,"interventionNames":35},"Sequence BA","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.",[30,31],[37,41],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":13},"Proso Millet-Based Bread","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.",[26,33],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":13},"White Wheat Bread","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.",[26,33],[46,49],{"name":47,"affiliation":5,"role":48},"Yasemin AKDEVELİOĞLU, PhD","STUDY_CHAIR",{"name":50,"affiliation":5,"role":51},"Mehmet M YALÇIN, PhD","PRINCIPAL_INVESTIGATOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":13,"email":57},"Şeyma Ş TAŞDEMİR, Research Assistant\u002FPhD Student","CONTACT","+90 541 830 2166","sehadettasdemir@gmail.com",{"type":51,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Seyma Sehadet TASDEMIR","Research Assistant",[62],{"name":63,"class":6},"The Scientific and Technological Research Council of Turkey","100657094","effect-of-proso-millet-based-bread-on-postprandial-glycemic-response-in-adults-with-type-2-diabetes-100657094",false,"NCT07833527","Effect of Proso Millet-Based Bread on Postprandial Glycemic Response in Adults With Type 2 Diabetes","Development of a Proso Millet-Based Bread Formulation and Investigation of Its Effect on Glycemic Response in Patients With Diabetes","Inclusion Criteria:\n\n* Age between 35 and 60 years Body mass index (BMI) ≥18.5 and ≤39.99 kg\u002Fm² 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\n\nExclusion Criteria:\n\n* 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 \\\u003C70 mg\u002FdL or \\>150 mg\u002FdL, 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","ALL","35 Years","60 Years",{"count":75,"type":76},52,"ESTIMATED","INTERVENTIONAL",[79],"NA","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.\n\nEach 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.\n\nDuring 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).\n\nThe 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.",[82],"Tip 2 Diabetes Mellitus",[84,85,86,87,88],"Glycemic Response","Type 2 Diabetes Mellitus","Proso Millet","Millet-Based Bread","Postprandial Blood Glucose","NOT_YET_RECRUITING","2026-09-16",{"date":92,"type":93},"2026-09-22","ACTUAL",{"date":95,"type":76},"2026-10-01",{"date":97,"type":76},"2026-12-31",{"name":5,"class":6}]