Effects of Legume Flour Particle Size on Postprandial Metabolic Responses to Bread of Healthy Subjects and Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ min), measured by continuous glucose monitoring, after consumption of the bread enriched with 30% larger particle size compared with white wheat bread.
研究概览
简要总结
The aim of the study is to investigate the effect of partial replacement of wheat flour by legume flour of different particle sizes on postprandial glucose responses and appetite sensations in healthy subjects and patients with type 2 diabetes.
Subjects will consume a portion of bread enriched with legume flours yielding 50 g of available carbohydrates as breakfast meal. To investigate the effect of the bread on glycemic response, a continuous glucose monitoring system (CGM) will be used. After an 180-min period, subjects will be given a second meal and glycemic response will be monitored for another 180 min. During the trial subjects must fill appropriate visual analogue scales regarding appetite sensations.
详细描述
The clinical trial will include two groups: (a) apparently healthy adults (up to 35 years old) and (b) individuals diagnosed with T2DM (aged 40-65 years). The study will investigate the effect of flour particle size on postprandial glycemic responses to bread and appetite sensations.
Within the framework of the clinical study, a total of three bread products will be prepared. Their final recipes will be determined after a series of tests to ensure the desired properties and organoleptic characteristics.
Intervention 1: White wheat bread with conventional fine wheat flour Intervention 2: White wheat bread with the addition of 30% finely milled chickpea flour Intervention 3: White wheat bread with the addition of 30% chickpea flour of larger particle size (>1.6 mm)
Inclusion and Exclusion Criteria
- Group 1
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cohort Healthy Participants
- •Inclusion Criteria:
- •Age: Adults aged 18-35 years.
- •Health Status: Healthy individuals with no diagnosed chronic diseases, including diabetes, cardiovascular disease, or gastrointestinal disorders.
- •Body Mass Index (BMI): 18.5-27 kg/m² (normal to overweight range).
- •Fasting Glucose: Normal fasting plasma glucose (<100 mg/dL or <5.6 mmol/L).
- •No regular use of medications known to affect glucose metabolism (e.g., insulin, metformin, corticosteroids).
- •Ability and willingness to comply with study procedures, including continuous glucose monitoring and standardized test meals.
- •Informed Consent: Ability to understand and provide written informed consent.
排除标准
- •Diagnosed chronic diseases: Diabetes (type 1 or type 2), cardiovascular disease, kidney or liver disease, gastrointestinal disorders (e.g., celiac disease, inflammatory bowel disease).
- •Abnormal glucose metabolism: Fasting plasma glucose ≥100 mg/dL (≥5.6 mmol/L) or HbA1c ≥5.7%.
- •Medication use: Regular use of medications that affect glucose metabolism, insulin sensitivity, or digestion (e.g., metformin, corticosteroids, GLP-1 analogs).
- •Allergies or intolerances: Allergy or intolerance to wheat, chickpeas, gluten, or other ingredients used in the study foods.
- •Pregnancy or lactation: Women who are pregnant, breastfeeding, or planning pregnancy during the study period.
- •Recent major weight change: Significant weight loss or gain (>5% body weight) in the past 3 months.
- •Extreme physical activity: Competitive athletes or individuals engaging in extreme exercise regimens that could influence glucose metabolism.
- •Inability to comply: Individuals unable or unwilling to follow study procedures, including continuous glucose monitoring and standardized test meals.
- •Cohort 2: Participants with Type 2 Diabetes Mellitus
- •Men and women aged 40-75 years. Body mass index (BMI) < 31 kg/m². Fasting plasma glucose > 125 mg/dL. HbA1c < 8.5%. Diagnosis of type 2 diabetes mellitus (T2DM) for at least 1 year before enrolment.
- •Stable treatment with hypoglycaemic, lipid-lowering, and/or antihypertensive medications for at least 3 months prior to enrolment.
- •Most participants will be recruited from the Diabetes Clinic of the 1st Propaedeutic Department of Internal Medicine, Laiko General Hospital.
- •Exclusion criteria
- •Endocrine, cardiovascular, pulmonary, renal, or gastrointestinal disorders that could affect study outcomes.
- •Sensitivity, intolerance, or allergy to any ingredients of the study breads. Pregnancy or breastfeeding. Eating disorders. Use of medications or dietary supplements considered incompatible with the study protocol.
研究组 & 干预措施
Conventional White Bread exclusively prepared with 100% White flour
Study participants will consume a single serving of refined white wheat bread prepared from finely milled flour, providing 50 g of available carbohydrate, and served as a control test meal under controlled conditions.
干预措施: Conventional white wheat bread (Dietary Supplement)
Wheat bread in which 30% of white flour is substituted with finely milled chickpea flour
Study Participants will consume a single serving of wheat bread in which 30% of finely milled wheat flour is replaced with finely milled chickpea flour, providing 50 g of available carbohydrate, served as a test meal under controlled conditions.
干预措施: Wheat bread with 30% finely milled chickpea flour (Dietary Supplement)
Wheat bread in which 30% of white flour is substituted with larger particle size chickpea flour
Study Participants will consume a single serving of wheat bread in which 30% of finely milled wheat flour is replaced with larger particle size chickpea flour providing 50 g of available carbohydrate, served as a test meal under controlled conditions.
干预措施: Wheat bread with 30% coarse chickpea flour (Dietary Supplement)
结局指标
主要结局
Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ min), measured by continuous glucose monitoring, after consumption of the bread enriched with 30% larger particle size compared with white wheat bread.
时间窗: 0-180 minutes postprandially.
For the study in healthy subjects a sample size of 20 adults is needed, based on a power calculation with an α of 0.05 and power of 0.80 to detect a between white wheat bread difference of 20% in postprandial glycemia. For the study in diabetic patients a sample size of 14 adults is needed, based on a power calculation with an α of 0.05 and power of 0.80 to detect a between white wheat bread difference of 30% in postprandial glycemia.
Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ minutes), measured by continuous glucose monitoring, after consumption of the bread enriched with 30% larger particle size compared with white wheat bread.
时间窗: 0-180 minutes postprandially.
For the study in healthy subjects a sample size of 20 adults is needed, based on a power calculation with an α of 0.05 and power of 0.80 to detect a between white wheat bread difference of 20% in postprandial glycemia. For the study in diabetic patients a sample size of 14 adults is needed, based on a power calculation with an α of 0.05 and power of 0.80 to detect a between white wheat bread difference of 30% in postprandial glycemia.
次要结局
- Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ min), measured by continuous glucose monitoring, after consumption of bread enriched with 30% chickpea flour compared with white wheat bread.(0-180 minutes postprandially)
- Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ min), measured by continuous glucose monitoring, after consumption of the bread enriched with 30% larger particle size compared with bread enriched with 30% refined chickpea flour(0-180 mins)
- Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ minutes), measured by continuous glucose monitoring, after consumption of bread enriched with 30% chickpea flour compared with white wheat bread.(0-180 minutes postprandially)
- Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ minutes) measured by continuous glucose monitoring, after consumption of the bread enriched with 30% larger particle size compared with bread enriched with 30% refined chickpea flour(0-180 minutes)
研究者
Amalia Yanni
Assistant Professor
Harokopio University