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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04299763
• Other study ID #: DOCNUTAL
• Status: Completed
• Phase: Phase 2
• Start date: June 19, 2018
• Est. completion date: January 18, 2019

Study information

• Verified date: March 2020
• Source: Centro de Estudios en Alimentación y Nutrición, Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 18, 2019
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 a-amylase inhibitor drugs.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Dietary Supplement:
• Oat Beta-glucan as a Supplement in Type 2 Diabetics
44 subjects were randomized into two groups, placebo (PL) and ß-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.

Locations

Country	Name	City	State
Chile	Centro de Estudios en Alimentación y Nutrición	Talca	Maule

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Estudios en Alimentación y Nutrición, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (6)

Abbasi NN, Purslow PP, Tosh SM, Bakovic M. Oat ß-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. — View Citation

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. — View Citation

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. — View Citation

Francelino Andrade E, Vieira Lobato R, Vasques Araújo T, Gilberto Zangerônimo M, Vicente Sousa R, José 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. Review. — View Citation

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

Shen XL, Zhao T, Zhou Y, Shi X, Zou Y, Zhao G. Effect of Oat ß-Glucan Intake on Glycaemic Control and Insulin Sensitivity of Diabetic Patients: A Meta-Analysis of Randomized Controlled Trials. Nutrients. 2016 Jan 13;8(1). pii: E39. doi: 10.3390/nu8010039. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Concentration of Glycated Hemoglobin A	12 weeks