Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Dietary Modification, Diabetes Mellitus Type 2, Insulin Tolerance, Diabetic Blood Glucose Monitoring

Intervention / Treatment
-----------------
* Other: HFD Meal: High fiber from food
* Dietary Supplement: HFS Meal: High fiber from supplement
* Other: UF Meal: usual amount of fiber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes Body Mass Index (BMI) <= 35 kg / m² Hemoglobin A1c (HbA1c) <= 9% Exclusion Criteria: 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 Cachexia Psychiatric disorder with impairment of understanding Participating in other research protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFD Meal: high fiber from food<br>HFD Meal: high amount of fiber from diet food sources (total fiber 9.7g; soluble fiber 5.4g) | Other: HFD Meal: High fiber from food<br>* High amount of fiber from diet food sources (HFD; total fiber 9.7g; soluble fiber 5.4g)<br>* Other names: HFD;|
| Experimental: HFS Meal: High fiber from supplement<br>HFS Meal: high amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - Fiber Mais, Nestlé | Dietary Supplement: HFS Meal: High fiber from supplement<br>* High amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - sachet 5 g Fiber Mais, Nestlé Brasil, São Paulo, BR<br>* Other names: HFS;|
| Experimental: UF Meal: usual amount of fiber<br>UF Meal: usual amount of fiber (total fiber 2.4g; soluble fiber 0.8g) | Other: UF Meal: usual amount of fiber<br>* Usual amount of fiber (UF; total fiber 2.4g; soluble fiber 0.8g)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses |  | Prior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary fiber, Dietary Supplements, Type 2 diabetes, Postprandial Period, Plasma insulin, Plasma glucose, Area Under Curve, Soluble fiber