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Trial record 10 of 20 for:    LDL- | barley

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02041104
Recruitment Status : Completed
First Posted : January 20, 2014
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborators:
University of Ljubljana
University Medical Centre Ljubljana
Information provided by (Responsible Party):
Mlinotest Zivilska Industrija d.d.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Metabolic Syndrome
Dyslipidemia
Obesity, Abdominal
Hyperglycemia
Hypertension
Interventions Dietary Supplement: Bread with added beta-glucans
Dietary Supplement: Placebo Comparator: Bread without added beta-glucans
Enrollment 51
Recruitment Details  
Pre-assignment Details In total, 81 participants were invited to trial trough national programme for metabolic disorder prevention and with help of family doctors. 30 participants were excluded due to personal reasons or because they did not meet inclusion criteria.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Period Title: Overall Study
Started 28 23
Completed 27 16
Not Completed 1 7
Reason Not Completed
Lost to Follow-up             1             4
discomfort during OGTT             0             3
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans Total
Hide Arm/Group Description

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. Experimental bread was prepared with concentrated beta-glucans barley flour, containing up to 15 % of beta-glucans.

Bread with added beta-glucans: Participants daily consumed bread with a high content of beta-glucans. They approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

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

Total of all reporting groups
Overall Number of Baseline Participants 27 16 43
Hide Baseline Analysis Population Description
The inclusion criteria for participants were as well diagnosed metabolic syndrome or high risk for metabolic syndrome development.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 16 participants 43 participants
50.93  (7.40) 54.00  (8.07) 52.07  (7.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 16 participants 43 participants
Female
20
  74.1%
13
  81.3%
33
  76.7%
Male
7
  25.9%
3
  18.8%
10
  23.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Total Cholesterol Levels
Hide Description Before the intervention, total cholesterol levels were determined.
Time Frame Baseline outcome measurement
Hide Outcome Measure Data
Hide Analysis Population Description
Total cholesterol levels were determined before diet intervention in both experimental groups.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: mmol/L
5.8  (1.01) 5.9  (1.13)
2.Primary Outcome
Title HDL-cholesterol Levels
Hide Description HDL-cholesterol levels were determined before diet intervention.
Time Frame Baseline measurement
Hide Outcome Measure Data
Hide Analysis Population Description
HDL-cholesterol levels were determined before diet intervention in both experimental groups.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: mmol/L
1.31  (0.44) 1.51  (0.52)
3.Primary Outcome
Title LDL-cholesterol Levels
Hide Description LDL-cholesterol levels were determined before intervention
Time Frame Baseline measurement
Hide Outcome Measure Data
Hide Analysis Population Description
LDL-cholesterol levels were determined in both experimental groups.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: mmol/L
3.99  (0.89) 4.02  (0.91)
4.Primary Outcome
Title Determination of Composition of Intestinal Microbiota From Fecal Samples
Hide Description Fecal sampling for microbiologic analysis of microbiota composition: Composition of intestinal microbiota will be determined with a combination of two molecular techniques denaturating gradient gel electrophoresis (DGGE) and quantitative real time PCR (RT-PCR).
Time Frame Outcome measurement at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
We analyzed faecal samples of 40 participants from the test and control group. Since DGGE method is only qualitative measurement, the only measurements of RT-PCR are shown. Results are presented as relative numbers of specific bacteria group ((number of specific bacteria group / all bacteria)*100).
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 25 15
Mean (Standard Deviation)
Unit of Measure: % of bacteria
Bacteroides – Prevotella group 7.95  (6.61) 6.94  (3.57)
Clostridium leptum group (cluster IV) 28.22  (11.33) 29.58  (11.90)
Clostridium coccoides group (cluster XIVa) 51.02  (22.91) 58.03  (23.79)
Enterobacteriaceae group 1.75  (5.65) 1.81  (5.46)
Bifidobacterium genus 0.62  (0.91) 0.54  (1.15)
Lactobacillus genus 0.03  (0.06) 0.31  (0.06)
5.Primary Outcome
Title Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)
Hide Description

Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. Before and after oral consumption of 75 g of glucose, plasma insulin concentrations were measured at following times:

0 min - before oral consumption of 75 g glucose 30 min, 60 min and 120 min - after oral consumption of 75 g glucose

Time Frame OGTT measurements performed before dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed before dietary intervention.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: uM/mL
Insulin concentration at time 0 min Number Analyzed 27 participants 16 participants
8.85  (5.87) 8.40  (7.75)
Insulin concentration at time 30 min Number Analyzed 27 participants 16 participants
50.01  (36.05) 39.60  (20.25)
Insulin concentration at time 60 min Number Analyzed 27 participants 16 participants
64.95  (50.55) 63.52  (28.09)
Insulin concentration at time 120 min Number Analyzed 26 participants 15 participants
50.15  (39.92) 35.87  (12.04)
6.Primary Outcome
Title Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
Hide Description

Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. Before and after oral consumption of 75 g of glucose, plasma glucose concentrations were measured at following times:

0 min - before oral consumption of 75 g glucose 30 min, 60 min and 120 min - after oral consumption of 75 g glucose

Time Frame Outcome OGTT measurements performed before dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed before dietary intervention.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: uM/mL
Glucose concentration at time 0 min Number Analyzed 27 participants 16 participants
5.12  (0.85) 5.00  (0.64)
Glucose concentration at time 30 min Number Analyzed 27 participants 16 participants
7.67  (1.91) 8.19  (1.60)
Glucose concentration at time 60 min Number Analyzed 27 participants 16 participants
7.16  (2.75) 7.46  (1.75)
Glucose concentration at time 120 min Number Analyzed 26 participants 16 participants
5.01  (1.12) 4.92  (0.76)
7.Primary Outcome
Title Systolic and Diastolic Blood Pressure
Hide Description Before the intervention, systolic and diastolic blood pressure were measured. Measurement was performed to obtain parameters for metabolic syndrome definition. Measurements after dietary intervention weren`t performed.
Time Frame Outcome measurement at baseline.
Hide Outcome Measure Data
Hide Analysis Population Description
Systolic and diastolic blood pressure were measured before dietary intervention in a population with metabolic syndrome or with high risk for metabolic syndrome development.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic blood pressure 135.56  (17.2) 137.31  (12.26)
Diastolic blood pressure 82.11  (9.65) 82.19  (5.73)
8.Primary Outcome
Title Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples
Hide Description Fecal sampling for SCFA determination: Content of specific SCFA (butyric acid, acetic acid and propionic acid) will be determined in fecal samples using Gas Chromatography.
Time Frame Outcome measurement at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
We analyzed the concentration of short fatty acids from faeces from 41 participants belonging to test (bread with added beta-glucans) or control group (bread without added beta-glucans).
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food is bread with high amount of barley beta-glucans. Experimental bread contains approximately 3,4 % (w/w) beta-glucans. Participants will consume 6 g of beta-glucans daily (approximately 200 g of bread per day). Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glycopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Testing bread has integrated flour with high amount of barley beta-glucans (ReducholTM). Beta-glucans are concentrated in flour up to 15 % with dry milling, sieving and air classification of barley flour.

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 week.

Placebo bread without added barley beta-glucans in testing product.

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.

Overall Number of Participants Analyzed 25 16
Mean (Standard Deviation)
Unit of Measure: g/kg
Acetic acid concentration 2.70  (1.58) 3.58  (2.03)
Propionic acid concentration 0.91  (0.60) 1.38  (0.9)
Butyric acid concentration 0.97  (0.71) 1.48  (0.98)
9.Primary Outcome
Title Triglyceride Levels
Hide Description Before the diet intervention, triglyceride levels were measured in test (consuming bread with added beta glucans) and in control group (consuming bread without added beta glucans).
Time Frame Outcome measure at baseline.
Hide Outcome Measure Data
Hide Analysis Population Description
Triglyceride levels were measured in participants with metabolic syndrome or with high risk for metabolic syndrome development.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: mmol/L
1.91  (1.23) 1.62  (1.06)
10.Secondary Outcome
Title Determination of Composition of Intestinal Microbiota From Fecal Samples
Hide Description Fecal sampling for microbiologic analysis of microbiota composition: Composition of intestinal microbiota will be determined with a combination of two molecular techniques denaturating gradient gel electrophoresis (DGGE) and quantitative real time PCR (RT-PCR).
Time Frame Outcome measurement after 4-week dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
We analyzed faecal samples of 40 participants from the test and control group. Since DGGE method is only qualitative measurement, the only measurements of RT-PCR are shown. Results are presented as relative numbers of specific bacteria group ((number of specific bacteria group / all bacteria)*100).
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 25 15
Mean (Standard Deviation)
Unit of Measure: % of bacteria
Bacteroides – Prevotella group 10.88  (8.80) 8.89  (5.70)
Clostridium leptum group (cluster IV) 26.41  (14.96) 30.38  (11.78)
Clostridium coccoides group (cluster XIVa) 47.22  (21.95) 52.99  (18.88)
Enterobacteriaceae group 0.79  (1.33) 1.58  (3.59)
Bifidobacterium genus 1.07  (1.41) 0.56  (0.58)
Lactobacillus genus 0.09  (0.36) 0.10  (0.31)
11.Secondary Outcome
Title Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples
Hide Description Fecal sampling for SCFA determination: Content of specific SCFA (butyric acid, acetic acid and propionic acid) will be determined in fecal samples using Gas Chromatography.
Time Frame Outcome measurement after 4-week dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
We analyzed the concentration of short fatty acids from faeces from 41 participants belonging to test (bread with added beta-glucans) or control group (bread without added beta-glucans) after 4-week intervention period.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 25 16
Mean (Standard Deviation)
Unit of Measure: g/kg
Acetic acid concentration 2.93  (1.74) 2.08  (1.03)
Propionic acid concentration 1.30  (0.90) 1.52  (2.50)
Butyric acid concentration 1.12  (0.77) 1.61  (2.09)
12.Secondary Outcome
Title LDL-cholesterol Levels
Hide Description LDL-cholesterol levels were determined after intervention
Time Frame Outcome measurement after 4-week dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
LDL-cholesterol levels were determined in both experimental groups.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: mmol/L
3.89  (0.89) 4.02  (0.66)
13.Secondary Outcome
Title HDL-cholesterol Levels
Hide Description HDL-cholesterol levels were determined after diet intervention.
Time Frame Outcome measurement after 4-week dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
HDL-cholesterol levels were determined after diet intervention in participants with metabolic syndrome or with high risk for metabolic syndrome development.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: mmol/L
1.30  (0.43) 1.47  (0.44)
14.Secondary Outcome
Title Triglyceride Levels
Hide Description After the diet intervention, triglyceride levels were measured in test (consuming bread with added beta glucans) and in control group (consuming bread without added beta glucans).
Time Frame Outcome measure after 4-week dietary intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
Triglyceride levels were measured in participants with metabolic syndrome or with high risk for metabolic syndrome development.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
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Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: mmol/L
1.72  (1.04) 1.50  (0.65)
15.Secondary Outcome
Title Total Cholesterol Levels
Hide Description After the intervention, total cholesterol levels were determined.
Time Frame Outcome measurement after 4-week dietary intervention
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Hide Analysis Population Description
Total cholesterol levels were determined before diet intervention in both experimental groups.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
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Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: mmol/L
5.54  (0.90) 5.96  (0.85)
16.Secondary Outcome
Title Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
Hide Description

Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. Before and after oral consumption of 75 g of glucose, plasma glucose concentration measurements were performed at following times:

0 min - before oral consumption of 75 g glucose 30 min, 60 min and 120 min - after oral consumption of 75 g glucose

Time Frame Outcome OGTT measurements performed after 4-week dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed after dietary intervention.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
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Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: uM/mL
Glucose concentration at time 0 min Number Analyzed 26 participants 16 participants
4.98  (1.28) 5.16  (0.71)
Glucose concentration at time 30 min Number Analyzed 23 participants 13 participants
6.81  (2.80) 7.86  (3.14)
Glucose concentration at time 60 min Number Analyzed 23 participants 12 participants
6.81  (2.80) 7.26  (3.39)
Glucose concentration at time 120 min Number Analyzed 23 participants 12 participants
5.29  (2.74) 4.41  (1.98)
17.Secondary Outcome
Title Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)
Hide Description

Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. Before and after oral consumption of 75 g of glucose, plasma insulin concentration measurements were performed at following times:

0 min - before oral consumption of 75 g glucose 30 min, 60 min and 120 min - after oral consumption of 75 g glucose

Time Frame Outcome OGTT measurements performed after 4-week dietary intervention
Hide Outcome Measure Data
Hide Analysis Population Description
In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed after dietary intervention.
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
Hide Arm/Group Description:

Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: uM/mL
Insulin concentration at time 0 min Number Analyzed 25 participants 15 participants
10.10  (5.64) 9.27  (3.65)
Insulin concentration at time 30 min Number Analyzed 23 participants 12 participants
53.16  (29.05) 47.07  (33.61)
Insulin concentration at time 60 min Number Analyzed 23 participants 11 participants
76.50  (60.54) 67.85  (35.41)
Insulin concentration at time 120 min Number Analyzed 23 participants 11 participants
56.34  (48.07) 43.5  (33.07)
Time Frame We performed a dietary intervention with high amounts of beta-glucans in test bread. We expected mild adverse events such as diarrhea or bloating, that disappear after stop consuming experimental bread. Regarding this, we collected adverse event data only during the interventional study (4 weeks).
Adverse Event Reporting Description

Adverse events were collected when participant detect some abnormalities during the intervention or during laboratory analysis.

Participants could report adverse events any time by telephone to investigators performing clinical testing.

 
Arm/Group Title Bread With Added Beta-glucans Bread Without Added Beta-glucans
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Experimental food was bread with a high amount of barley beta-glucans. Experimental bread contained approximately 3,4 g beta-glucans per 100 g of bread. Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glucopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enables beta-glucans their functional action that mostly depends on their viscosity and solubility. For test bread preparation, we used flour with concentrated beta-glucans up to 15 %.

Bread with added beta-glucans: Participants approximately consumed 6 g beta-glucans per day in 200 g of bread. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics

Placebo bread without added barley beta-glucans in the testing product.

Placebo Comparator: Bread without added beta-glucans-Participants daily consumed placebo bread without any added beta-glucans (approximately 200 g bread per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

All-Cause Mortality
Bread With Added Beta-glucans Bread Without Added Beta-glucans
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)      0/23 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Bread With Added Beta-glucans Bread Without Added Beta-glucans
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/28 (3.57%)      3/23 (13.04%)    
Gastrointestinal disorders     
Diarrhea * [1]  1/28 (3.57%)  1 0/23 (0.00%)  0
Investigations     
Discomfort during OGTT analysis * [2]  0/28 (0.00%)  0 3/23 (13.04%)  3
*
Indicates events were collected by non-systematic assessment
[1]
After few days of dietary trial, diarrhea appear to one participant in test group consuming bread with added beta-glucans.
[2]
Participants felt dizziness or sickness during first OGTT analysis. They refused to continue diet intervention.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bread With Added Beta-glucans Bread Without Added Beta-glucans
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/23 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ana Velikonja
Organization: Mlinotest d. d.
Phone: 0038651321785
EMail: anaa.velikonja@gmail.com
Publications:
(1) Izydorczyk MS,Dexter JE. Barley beta-glucans and arabinoxylans: Molecular structure, physicochemical properties, and uses in food products-a Review. Food Research International 41: 850-868, 2008
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Responsible Party: Mlinotest Zivilska Industrija d.d.
ClinicalTrials.gov Identifier: NCT02041104     History of Changes
Other Study ID Numbers: MLINOTEST/618-001
First Submitted: January 15, 2014
First Posted: January 20, 2014
Results First Submitted: May 15, 2018
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019