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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04299763
Recruitment Status : Completed
First Posted : March 9, 2020
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
José Luis Pino Villalón, University of 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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Dietary Supplement: Oat Beta-glucan as a Supplement in Type 2 Diabetics Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Oat β-glucans as a Supplement in Chilean Subjects With Type 2 Diabetes for Metabolic Control
Actual Study Start Date : June 19, 2018
Actual Primary Completion Date : October 10, 2018
Actual Study Completion Date : January 18, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 12 weeks ]
    Concentration of Glycated Hemoglobin A



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04299763


Locations
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Chile
Centro de Estudios en Alimentación y Nutrición
Talca, Maule, Chile, 3480428
Sponsors and Collaborators
Centro de Estudios en Alimentación y Nutrición, Chile
Publications:

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Responsible Party: José Luis Pino Villalón, Nutritionist, University of Chile
ClinicalTrials.gov Identifier: NCT04299763    
Other Study ID Numbers: DOCNUTAL
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Luis Pino Villalón, University of Chile:
beta-Glucans
Diabetes Mellitus, Type 2
Chile
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases