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OpenTrials
Completed

NCT Number: NCT04299763

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro de Estudios en Alimentación y Nutrición

Talca, Maule Region, 3480428, Chile

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Oat Beta-glucan as a Supplement in Type 2 Diabetics

Dietary Supplement

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.

Primary outcomes

  1. HbA1c

    Time frame: 12 weeks

    Concentration of Glycated Hemoglobin A

Sponsors and collaborators

Lead sponsor

Centro de Estudios en Alimentación y Nutrición, Chile

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 9, 2020
Registry last updated
Mar 9, 2020

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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