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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-19

Study Completion Date

2019-01-18

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.

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Detailed Description

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Conditions

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Beta-Glucan (BETA)

experimental group, received a supplement of oats beta-glucan (5 g) for 12 weeks.

Group Type EXPERIMENTAL

Oat Beta-glucan as a Supplement in Type 2 Diabetics

Intervention Type 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.

Control (CN)

placebo group, received a supplement of cellulose microcrystalline (5g) for 12 weeks.

Group Type PLACEBO_COMPARATOR

Oat Beta-glucan as a Supplement in Type 2 Diabetics

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No