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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HFD Meal: high fiber from food

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

Group Type EXPERIMENTAL

HFD Meal: High fiber from food

Intervention Type OTHER

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

HFS Meal: High fiber from supplement

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

Group Type EXPERIMENTAL

HFS Meal: High fiber from supplement

Intervention Type DIETARY_SUPPLEMENT

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

UF Meal: usual amount of fiber

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

Group Type EXPERIMENTAL

UF Meal: usual amount of fiber

Intervention Type OTHER

Usual amount of fiber (UF; total fiber 2.4g; soluble fiber 0.8g)

Interventions

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HFD Meal: High fiber from food

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

Intervention Type OTHER

HFS Meal: High fiber from supplement

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

Intervention Type DIETARY_SUPPLEMENT

UF Meal: usual amount of fiber

Usual amount of fiber (UF; total fiber 2.4g; soluble fiber 0.8g)

Intervention Type OTHER

Other Intervention Names

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HFD HFS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No