Development of a Proso Millet-Based Bread Formulation and Investigation of Its Effect on Glycemic Response in Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- Incremental Area Under the Curve (iAUC) for Postprandial Blood Glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sequence AB
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.
干预措施: Proso Millet-Based Bread (Other)
Sequence AB
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.
干预措施: White Wheat Bread (Other)
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.
干预措施: Proso Millet-Based Bread (Other)
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.
干预措施: White Wheat Bread (Other)
结局指标
主要结局
Incremental Area Under the Curve (iAUC) for Postprandial Blood Glucose
时间窗: 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.
次要结局
未报告次要终点
研究者
Seyma Sehadet TASDEMIR
Research Assistant
Gazi University