Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes
Glycemic and Satiety Response to Meals With Different Fiber Content and Glycemic Index in Type 2 Diabetic Patients
研究概览
详细说明
Design study:
Single-blind crossover randomized clinical trial
Hypothesis:
A meal with high GI and high fiber content determines a lower glycemic response compared to a meal with high GI and low fiber content (fiber beneficial effect on glycemic response independent of glycemic index.
Test meals:
Four test meals isocaloric and with the same proportion of macronutrients will be evaluated (5 kcal/kg, 17% of energy provided by protein, 58% of energy provided by carbohydrates, and 25% of energy provided by fat):
Test Meal A:high glycemic index (GI= 60.3%) and high fiber content(5.88g) Test Meal B:high glycemic index (GI= 62.8%) and LOW fiber content(2.05g) Test Meal C:low glycemic index (GI= 37.0%) and high fiber content(5.75g) Test Meal D:low glycemic index (GI= 38.4%) and high fiber content(1.91g)
Outcomes:
Glycemic response: serum glucose and insulin Satiety response: serum ghrelin and subjective assessment of satiety by a specific scale for measurement of appetite in single test meal studies.
Logistic:
Patients will undergo a clinical, nutritional and laboratory evaluation for confirm the inclusion criteria and will be request to give their written informed consent.
All participants will test each meal with a mean of seven days separating the individual test days.A 12h fast will precede all the study visits.Pre-and postprandial blood samples will be draw to determine the concentrations of serum insulin and plasma glucose, and ghrelin through an antecubital cannula before and 15, 30, 45, 60, 90, 120 and 180 min after the test meals. The VAS scale will be applied in these times.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Rio Grande do Sul
-
Porto Alegre、Rio Grande do Sul、巴西
- 招聘中
- Hospital de Clinicas de Porto Alegre
-
接触：
- Flávia M Silva
- 电话号码：93771824
- 邮箱：flavia.moraes.silva@hotmail.com
-
副研究员：
- Thais Steemburgo
-
副研究员：
- Caroline Kramer
-
副研究员：
- Giovana Menegotto
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- type 2 diabetes,
- HbA1c < 9%,
- BMI < 35kg/m²,
- Metformin and/or diet as treatment for diabetes
Exclusion Criteria:
- Use of insulin as diabetes treatment
- digestive disease with malabsorption
- diabetes neuropathy with gastroparesis
学习计划
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：meal D
low fiber and low GI
|
meals with different fiber content and glycemic index
four different meal regarding GI and fiber content
|
|
实验性的：meal C
low Fiber and High GI
|
meals with different fiber content and glycemic index
four different meal regarding GI and fiber content
|
|
实验性的：meal B
high Fiber and low GI
|
meals with different fiber content and glycemic index
four different meal regarding GI and fiber content
|
|
实验性的：meal A
high fiber and high GI meal
|
meals with different fiber content and glycemic index
four different meal regarding GI and fiber content
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
glycemic control
大体时间：fasting and post-prandial (differents times during 180 minutes)
|
glucose and insulin
|
fasting and post-prandial (differents times during 180 minutes)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
measures of satiety and appetite
大体时间：fasting and post-prandial (different times for 180 min)
|
ghrelin and subjective analogue scale of appetite
|
fasting and post-prandial (different times for 180 min)
|
合作者和调查者
合作者
调查人员
- 学习椅：Flávia M Silva、Hospital de Clinicas de Porto Alegre
- 学习椅：Thais Steemburgo、Hospital de Clinicas de Porto Alegre
- 学习椅：Caroline Kramer、Hospital de Clinicas de Porto Alegre
- 学习椅：Giovana Menegotto、Hospital de Clinicas de Porto Alegre
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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