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

Phase 2

Completed

• Conditions: Type2 Diabetes

• Registration Number: NCT04299763
• Lead Sponsor: Centro de Estudios en Alimentación y Nutrición, 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-19
• Primary Completion: 2018-10-10
• Study Completion: 2019-01-18
• Study First Submitted: 2019-09-17
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-05
• Last Update Submitted: 2020-03-05
• Study First Posted: 2020-03-09
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	12 weeks	Concentration of Glycated Hemoglobin A

Trial Locations

Locations (1)

Centro de Estudios en Alimentación y Nutrición; 🇨🇱 Talca, Maule, Chile