Plasma Glucose and Insulin Responses After Consumption of Breakfasts With Different Sources of Soluble Fiber in Type 2 Diabetes Patients: a Randomized Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses
研究概览
简要总结
To compare the acute effect of soluble fiber intake from foods or supplement after a common meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. The hypothesis is a meal with a high content of soluble fiber from food determines glycemic and insulinemic response similar to a meal with a high content of soluble fiber from supplement sources.
详细描述
Three breakfasts (high amount of fiber from diet food sources - HFD, high amount of soluble fiber from guar gum supplement - HFS and usual amount of fiber -UF), isocaloric and similar distribution of carbohydrates, proteins and lipids, the order of breakfasts randomly determined. Meals HFD and HFS have the same amount of fiber from different sources, origin in food and supplement respectively. Meal UF consist of the same foods meal HFS, but without the use of soluble fiber supplement and white bread instead of rye bread (low fiber content in relation to meals HFD and HFS). The supplement (Sachet 5g - Fiber Mais ®: 60% guar gum and 40% inulin) will be added to the plain water to meal HFD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes
- •Body Mass Index (BMI) <= 35 kg / m²
- •Hemoglobin A1c (HbA1c) <= 9%
排除标准
- •Serum creatinine >2.0 mg/dL
- •Digestive diseases (e.g. malabsorption)
- •Severe autonomic neuropathy (presence of symptomatic postural hypotension, gastroparesis, diabetic diarrhea)
- •Recent cardiovascular event
- •Psychiatric disorder with impairment of understanding
- •Participating in other research protocol
结局指标
主要结局
Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses
时间窗: Prior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal
次要结局
未报告次要终点
研究者
Mirela Jobim de Azevedo
PhD
Hospital de Clinicas de Porto Alegre