NCT04299763

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

Oat β-glucans as a Supplement in Chilean Subjects With Type 2 Diabetes for Metabolic Control

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Centro de Estudios en Alimentación y Nutrición, Chile · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oat 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.

Timeline

• Start date: 2018-06-19
• Primary completion: 2018-10-10
• Completion: 2019-01-18
• First posted: 2020-03-09
• Last updated: 2020-03-09

Locations

1 site across 1 country: Chile