Type2 Diabetes
Conditions
Keywords
beta-Glucans, Diabetes Mellitus, Type 2, Chile
Brief summary
Objective: To evaluate the effect of oat β-glucans on the satiety perception, metabolic control and intestinal microbiota of type 2 diabetics from Talca, Chile. Methodology: Clinical trial, controlled, randomized, double blind and parallel design. The recruited (40 subjects) were randomized into two groups, placebo (PL) and ß-glucan (BG). 5 gr of oat ß-glucan or placebo were delivered for 12 weeks to be added in breakfast. Blood and stool samples were requested at the beginning and at the end of the intervention. The investigators quantify: HbA1c in whole blood, fasting blood glucose, basal insulin, C-peptide, tumor necrosis factor alpha (TNF-a), interleukin (IL) 6, IL-8, IL-10, IL1β, cortisol, ghrelin, glucagon-like peptide type 1 (GLP -1), YY peptide (PYY), Resistin, Leptin and serum Lipid Profile. The subjective perception of hunger / satiety were established through an analogous visual survey. Calorie intake was determined by 24-hour recall survey. Were analyzed the phylum: Firmicutes, Bacteroidetes and Verrucomicrobia, and the populations of Bifidobacteria spp, Lactobacillus spp, butyrate producing bacteria, Akkermansia Muciniphila and total bacteria of fecal microbiota, using quantitative polymerase chain reaction (qPCR) with specific primers. All participants were instructed not to make changes in their usual eating habits, physical activity and pharmacological treatments.
Interventions
DIETARY_SUPPLEMENTOat Beta-glucan as a Supplement in Type 2 Diabetics
44 subjects were randomized into two groups, placebo (PL) and β-glucan (BG). Each person received a package with a supplement sufficient for 12 weeks, adding 5 g of supplement to breakfast, which could contain beta-glucan or not. Blood and stool samples were requested at the beginning and at the end of the intervention.
Sponsors
Centro de Estudios en Alimentación y Nutrición, Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Two groups were used: experimental (n 17): they received oat beta-glucan supplement to be added to breakfast (5 g). Control group: they received a placebo supplement (microcrystalline cellulose). Both groups received a container with the product and a dosing measure (5 g). The intervention was developed for 12 weeks. Blood samples and stools were taken at the beginning and end of the intervention.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects with type 2 diabetes mellitus * Use of oral hypoglycemic agents (Metformin) * 30 to 45 years * More than one year and less than 10 diabetes * no major chronic complications * Hb A1c between 7 to 9% * BMI between 30-35 Kg / mt2.
Exclusion criteria
* Pregnant women * Acute and / or chronic intestinal pathologies (malabsorption syndrome, celiac disease, chronic inflammatory bowel diseases, among others.), * Drugs that interfere with the microbiota (antibiotics, anti-inflammatories, laxatives, prokinetics), * Organic insufficiencies (cardiac, hepatic, renal, respiratory), or with immunodeficiencies (HIV, chemotherapy, radiotherapy, transplanted). * Presence of smoking habit. * Regular probiotic or prebiotic intake (more than 2 months) * Dipeptidyl peptidase 4 inhibitors (DPP4) and α-amylase inhibitor drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 12 weeks | Concentration of Glycated Hemoglobin A |
Countries
Chile
Outcome results
None listed