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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02204384
Enrollment
19
Registered
2014-07-30
Start date
2014-08-31
Completion date
2017-01-31
Last updated
2017-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Dietary fiber, Dietary Supplements, Type 2 diabetes, Postprandial Period, Plasma insulin, Plasma glucose, Area Under Curve, Soluble fiber

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.

Interventions

OTHERHFD Meal: High fiber from food

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

DIETARY_SUPPLEMENTHFS 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

OTHERUF Meal: usual amount of fiber

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

Sponsors

Federal University of Rio Grande do Sul
CollaboratorOTHER
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responsesPrior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026