Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes

Study Overview
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Brief Summary
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The aim of this study is to assess the post-prandial response of four breakfast with different content of dietary fiber and glycemic index on glycemic response and satiety in patients with type 2 diabetes.

Detailed Description
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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.

Official Title
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Glycemic and Satiety Response to Meals With Different Fiber Content and Glycemic Index in Type 2 Diabetic Patients

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: GI and fiber meals
* Other: meals


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: meal D<br>low fiber and low GI | Other: GI and fiber meals<br>* meals with different fiber content and glycemic index<br>Other: meals<br>* four different meal regarding GI and fiber content<br>|
| Experimental: meal C<br>low Fiber and High GI | Other: GI and fiber meals<br>* meals with different fiber content and glycemic index<br>Other: meals<br>* four different meal regarding GI and fiber content<br>|
| Experimental: meal B<br>high Fiber and low GI | Other: GI and fiber meals<br>* meals with different fiber content and glycemic index<br>Other: meals<br>* four different meal regarding GI and fiber content<br>|
| Experimental: meal A<br>high fiber and high GI meal | Other: GI and fiber meals<br>* meals with different fiber content and glycemic index<br>Other: meals<br>* four different meal regarding GI and fiber content<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control | glucose and insulin | fasting and post-prandial (differents times during 180 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measures of satiety and appetite | ghrelin and subjective analogue scale of appetite | fasting and post-prandial (different times for 180 min) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fiber, glycemic index, glycemic response, diabetes, ghrelin