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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Oat Beta-glucan as a Supplement in Type 2 Diabetics


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beta-Glucan (BETA)<br>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<br>* 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.<br>|
| Placebo Comparator: Control (CN)<br>placebo group, received a supplement of cellulose microcrystalline (5g) for 12 weeks. | Dietary Supplement: Oat Beta-glucan as a Supplement in Type 2 Diabetics<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beta-Glucans, Diabetes Mellitus, Type 2, Chile