Oat Beta-glucan as a Supplement in Chilean Type 2 Diabetics

Centro de Estudios en Alimentación y Nutrición, Chile

Status and phase

Completed

Phase 2

Conditions

Type2 Diabetes

Treatments

Dietary Supplement: Oat Beta-glucan as a Supplement in Type 2 Diabetics

Study type

Interventional

Funder types

Other

Identifiers

NCT04299763

DOCNUTAL

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Volunteers

No Healthy Volunteers

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.