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OpenTrials
Completed

NCT Number: NCT02204384

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

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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Key information

Conditions

Dietary Modification Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Diabetic Blood Glucose Monitoring Endocrine System Diseases Glucose Metabolism Disorders Insulin Tolerance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HFD Meal: High fiber from food

Other

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

Other names: HFD

HFS Meal: High fiber from supplement

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

Other names: HFS

UF Meal: usual amount of fiber

Other

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

Primary outcomes

  1. Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses

    Time frame: Prior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Federal University of Rio Grande do Sul

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 30, 2014
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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