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

Not Applicable

Completed

• Conditions: Dietary Modification; Diabetes Mellitus Type 2; Insulin Tolerance; Diabetic Blood Glucose Monitoring

• Registration Number: NCT02204384
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-30
• Study Start: 2014-08
• Primary Completion: 2016-03
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil