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

Hospital de Clinicas de Porto Alegre

Status: Completed

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

Treatments: Other: UF Meal: usual amount of fiber; Other: HFD Meal: High fiber from food; Dietary Supplement: HFS Meal: High fiber from supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02204384

140161

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 3 patient groups

HFD Meal: high fiber from food

Experimental group

Description:

HFD Meal: high amount of fiber from diet food sources (total fiber 9.7g; soluble fiber 5.4g)

Treatment:

Other: HFD Meal: High fiber from food

HFS Meal: High fiber from supplement

Experimental group

Description:

HFS Meal: high amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - Fiber Mais, Nestlé

Treatment:

Dietary Supplement: HFS Meal: High fiber from supplement

UF Meal: usual amount of fiber

Experimental group

Description:

UF Meal: usual amount of fiber (total fiber 2.4g; soluble fiber 0.8g)

Treatment:

Other: UF Meal: usual amount of fiber