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
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
- Metabolic Syndrome
- Dyslipidemia
- Obesity, Abdominal
- Hyperglycemia
- Hypertension
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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