Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid Metabolism

NCT02041104 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2019-06-03

Study results available
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Summary

The purpose of this study is to investigate if daily consumption of barley beta-glucans effect lipid and glucose metabolism and alter intestinal microbiota composition in participants with metabolic syndrome or with high risk for metabolic syndrome development. It is assumed that 4-week intervention with beta-glucans will improve some clinical signs of metabolic syndrome and alter composition of intestinal microbiota. Variation in microbiota composition will be investigated with emphasis on Bacteroidetes and Firmicutes ratio. Furthermore it is presupposed that consumption of beta-glucans will stimulate growth of beneficial intestinal bacteria from genus Lactobacillus and Bifidobacteria and consequently effect production of short chain fatty acids in population with metabolic syndrome. Moreover it is presupposed that 4-week consumption of beta-glucans will have influence on glucose metabolism and will consequently improve insulin resistance within people with metabolic syndrome or high risk for metabolic syndrome development. It is assumed that 4-week consumption of beta-glucans will improve specific plasma lipid content in population with metabolic syndrome.

Conditions

Interventions

DIETARY_SUPPLEMENT

Bread with added beta-glucans

Participants will daily consume bread with high content of beta-glucans. They will approximately consume 6 g beta-glucans per day in 200 g of bread. Intervention period will be 4 weeks. Meanwhile the participants will remain their usual eating habits except consuming any pro- or pre-biotics

DIETARY_SUPPLEMENT

Placebo Comparator: Bread without added beta-glucans

Participants will daily consume placebo bread without any added beta-glucans (approximately 200 g per day). Intervention period will be 4 weeks. Meanwhile the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Sponsors & Collaborators

  • University of Ljubljana

    collaborator OTHER
  • University Medical Centre Ljubljana

    collaborator OTHER
  • Mlinotest Zivilska Industrija d.d.

    lead INDUSTRY

Principal Investigators

  • Ana Velikonja, PhD student · Mlinotest d.d. Zivilska Industrija

  • Rok Orel, M.D., D.Sc. · University Medical Centre Ljubljana

  • Gorazd Avgustin, UP · University of Ljubljana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Slovenia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02041104 on ClinicalTrials.gov