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

March 5, 2020 updated by: José Luis Pino Villalón, Centro de Estudios en Alimentación y Nutrición, Chile

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Maule
      • Talca, Maule, Chile, 3480428
        • Centro de Estudios en Alimentación y Nutrición

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beta-Glucan (BETA)
experimental group, received a supplement of oats beta-glucan (5 g) for 12 weeks.
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.
Placebo Comparator: Control (CN)
placebo group, received a supplement of cellulose microcrystalline (5g) for 12 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 12 weeks
Concentration of Glycated Hemoglobin A
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Estudios en Alimentación y Nutrición, Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2018

Primary Completion (Actual)

October 10, 2018

Study Completion (Actual)

January 18, 2019

Study Registration Dates

First Submitted

September 17, 2019

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOCNUTAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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