Clinical trial NCT02204384: Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Diabetes Mellitus Type 2
Insulin Tolerance
Diabetic Blood Glucose Monitoring
Keywords: Dietary fiber
Dietary Supplements
Type 2 diabetes
Postprandial Period
Plasma insulin
Plasma glucose
Area Under Curve
Soluble fiber
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2014-07-30
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses
timeFrame: Prior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Mirela J Azevedo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Carvalho CM, de Paula TP, Viana LV, Machado VM, de Almeida JC, Azevedo MJ. 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. Am J Clin Nutr. 2017 Nov;106(5):1238-1245. doi: 10.3945/ajcn.117.157263. Epub 2017 Aug 30.