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

• ClinicalTrials.gov Identifier: NCT04299763
• Recruitment Status: Completed
• First Posted: March 9, 2020
• Last Update Posted: March 9, 2020
• Sponsor: Centro de Estudios en Alimentación y Nutrición, Chile
• Information provided by (Responsible Party): José Luis Pino Villalón, University of Chile

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Chile

Centro de Estudios en Alimentación y Nutrición

Talca, Maule, Chile, 3480428

Sponsors and Collaborators

Centro de Estudios en Alimentación y Nutrición, Chile

More Information

Publications:

Francelino Andrade E, Vieira Lobato R, Vasques Araujo T, Gilberto Zangeronimo M, Vicente Sousa R, Jose Pereira L. Effect of beta-glucans in the control of blood glucose levels of diabetic patients: a systematic review. Nutr Hosp. 2014 Jan 1;31(1):170-7. doi: 10.3305/nh.2015.31.1.7597.

Abbasi NN, Purslow PP, Tosh SM, Bakovic M. Oat beta-glucan depresses SGLT1- and GLUT2-mediated glucose transport in intestinal epithelial cells (IEC-6). Nutr Res. 2016 Jun;36(6):541-52. doi: 10.1016/j.nutres.2016.02.004. Epub 2016 Feb 18.

Beck EJ, Tosh SM, Batterham MJ, Tapsell LC, Huang XF. Oat beta-glucan increases postprandial cholecystokinin levels, decreases insulin response and extends subjective satiety in overweight subjects. Mol Nutr Food Res. 2009 Oct;53(10):1343-51. doi: 10.1002/mnfr.200800343.

Dong J, Cai F, Shen R, Liu Y. Hypoglycaemic effects and inhibitory effect on intestinal disaccharidases of oat beta-glucan in streptozotocin-induced diabetic mice. Food Chem. 2011 Dec 1;129(3):1066-71. doi: 10.1016/j.foodchem.2011.05.076. Epub 2011 May 25.

Pentikainen S, Karhunen L, Flander L, Katina K, Meynier A, Aymard P, Vinoy S, Poutanen K. Enrichment of biscuits and juice with oat beta-glucan enhances postprandial satiety. Appetite. 2014 Apr;75:150-6. doi: 10.1016/j.appet.2014.01.002. Epub 2014 Jan 14.

Shen XL, Zhao T, Zhou Y, Shi X, Zou Y, Zhao G. Effect of Oat beta-Glucan Intake on Glycaemic Control and Insulin Sensitivity of Diabetic Patients: A Meta-Analysis of Randomized Controlled Trials. Nutrients. 2016 Jan 13;8(1):39. doi: 10.3390/nu8010039.

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

• 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:

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases