Oat Beta-glucan as a Supplement in Chilean Type 2 Diabetics
Primary Purpose
Type2 Diabetes
Status
Completed
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Oat Beta-glucan as a Supplement in Type 2 Diabetics
Sponsored by

About this trial
This is an interventional supportive care trial for Type2 Diabetes focused on measuring beta-Glucans, Diabetes Mellitus, Type 2, Chile
Eligibility 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.
Sites / Locations
- Centro de Estudios en Alimentación y Nutrición
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Beta-Glucan (BETA)
Control (CN)
Arm Description
experimental group, received a supplement of oats beta-glucan (5 g) for 12 weeks.
placebo group, received a supplement of cellulose microcrystalline (5g) for 12 weeks.
Outcomes
Primary Outcome Measures
HbA1c
Concentration of Glycated Hemoglobin A
Secondary Outcome Measures
Full Information
NCT ID
NCT04299763
First Posted
September 17, 2019
Last Updated
March 5, 2020
Sponsor
Centro de Estudios en Alimentación y Nutrición, Chile
1. Study Identification
Unique Protocol Identification Number
NCT04299763
Brief Title
Oat Beta-glucan as a Supplement in Chilean Type 2 Diabetics
Official Title
Oat β-glucans as a Supplement in Chilean Subjects With Type 2 Diabetes for Metabolic Control
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
January 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro de Estudios en Alimentación y Nutrición, Chile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
Keywords
beta-Glucans, Diabetes Mellitus, Type 2, Chile
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beta-Glucan (BETA)
Arm Type
Experimental
Arm Description
experimental group, received a supplement of oats beta-glucan (5 g) for 12 weeks.
Arm Title
Control (CN)
Arm Type
Placebo Comparator
Arm Description
placebo group, received a supplement of cellulose microcrystalline (5g) for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oat Beta-glucan as a Supplement in Type 2 Diabetics
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c
Description
Concentration of Glycated Hemoglobin A
Time Frame
12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Centro de Estudios en Alimentación y Nutrición
City
Talca
State/Province
Maule
ZIP/Postal Code
3480428
Country
Chile
12. IPD Sharing Statement
Citations:
PubMed Identifier
25561108
Citation
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.
Results Reference
background
PubMed Identifier
27188900
Citation
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.
Results Reference
background
PubMed Identifier
19753601
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.
Results Reference
background
PubMed Identifier
25212338
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.
Results Reference
background
PubMed Identifier
24434584
Citation
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.
Results Reference
background
PubMed Identifier
26771637
Citation
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.
Results Reference
background
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Oat Beta-glucan as a Supplement in Chilean Type 2 Diabetics
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