Trial Outcomes & Findings for Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid Metabolism (NCT NCT02041104)
NCT ID: NCT02041104
Last Updated: 2019-06-03
Results Overview
Before the intervention, total cholesterol levels were determined.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Baseline outcome measurement
Results posted on
2019-06-03
Participant Flow
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.
Participant milestones
| Measure |
Bread With Added Beta-glucans
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
|
Bread Without Added Beta-glucans
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 Study
STARTED
|
28
|
23
|
|
Overall Study
COMPLETED
|
27
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
Reasons for withdrawal
| Measure |
Bread With Added Beta-glucans
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
|
Bread Without Added Beta-glucans
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 Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
discomfort during OGTT
|
0
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bread With Added Beta-glucans
n=27 Participants
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
|
Bread Without Added Beta-glucans
n=16 Participants
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
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.93 years
STANDARD_DEVIATION 7.40 • n=27 Participants
|
54.00 years
STANDARD_DEVIATION 8.07 • n=16 Participants
|
52.07 years
STANDARD_DEVIATION 7.71 • n=43 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=27 Participants
|
13 Participants
n=16 Participants
|
33 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=27 Participants
|
3 Participants
n=16 Participants
|
10 Participants
n=43 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline outcome measurementPopulation: Total cholesterol levels were determined before diet intervention in both experimental groups.
Before the intervention, total cholesterol levels were determined.
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=27 Participants
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
|
|---|---|---|
|
Total Cholesterol Levels
|
5.9 mmol/L
Standard Deviation 1.13
|
5.8 mmol/L
Standard Deviation 1.01
|
PRIMARY outcome
Timeframe: Baseline measurementPopulation: HDL-cholesterol levels were determined before diet intervention in both experimental groups.
HDL-cholesterol levels were determined before diet intervention.
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=27 Participants
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
|
|---|---|---|
|
HDL-cholesterol Levels
|
1.51 mmol/L
Standard Deviation 0.52
|
1.31 mmol/L
Standard Deviation 0.44
|
PRIMARY outcome
Timeframe: Baseline measurementPopulation: LDL-cholesterol levels were determined in both experimental groups.
LDL-cholesterol levels were determined before intervention
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=27 Participants
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
|
|---|---|---|
|
LDL-cholesterol Levels
|
4.02 mmol/L
Standard Deviation 0.91
|
3.99 mmol/L
Standard Deviation 0.89
|
PRIMARY outcome
Timeframe: Outcome measurement at baselinePopulation: 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).
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).
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=15 Participants
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.
|
Bread With Added Beta-glucans
n=25 Participants
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
|
|---|---|---|
|
Determination of Composition of Intestinal Microbiota From Fecal Samples
Clostridium coccoides group (cluster XIVa)
|
58.03 % of bacteria
Standard Deviation 23.79
|
51.02 % of bacteria
Standard Deviation 22.91
|
|
Determination of Composition of Intestinal Microbiota From Fecal Samples
Enterobacteriaceae group
|
1.81 % of bacteria
Standard Deviation 5.46
|
1.75 % of bacteria
Standard Deviation 5.65
|
|
Determination of Composition of Intestinal Microbiota From Fecal Samples
Bacteroides - Prevotella group
|
6.94 % of bacteria
Standard Deviation 3.57
|
7.95 % of bacteria
Standard Deviation 6.61
|
|
Determination of Composition of Intestinal Microbiota From Fecal Samples
Clostridium leptum group (cluster IV)
|
29.58 % of bacteria
Standard Deviation 11.90
|
28.22 % of bacteria
Standard Deviation 11.33
|
|
Determination of Composition of Intestinal Microbiota From Fecal Samples
Bifidobacterium genus
|
0.54 % of bacteria
Standard Deviation 1.15
|
0.62 % of bacteria
Standard Deviation 0.91
|
|
Determination of Composition of Intestinal Microbiota From Fecal Samples
Lactobacillus genus
|
0.31 % of bacteria
Standard Deviation 0.06
|
0.03 % of bacteria
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: OGTT measurements performed before dietary interventionPopulation: In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed before dietary intervention.
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
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=27 Participants
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
|
|---|---|---|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)
Insulin concentration at time 120 min
|
35.87 uM/mL
Standard Deviation 12.04
|
50.15 uM/mL
Standard Deviation 39.92
|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)
Insulin concentration at time 0 min
|
8.40 uM/mL
Standard Deviation 7.75
|
8.85 uM/mL
Standard Deviation 5.87
|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)
Insulin concentration at time 30 min
|
39.60 uM/mL
Standard Deviation 20.25
|
50.01 uM/mL
Standard Deviation 36.05
|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)
Insulin concentration at time 60 min
|
63.52 uM/mL
Standard Deviation 28.09
|
64.95 uM/mL
Standard Deviation 50.55
|
PRIMARY outcome
Timeframe: Outcome OGTT measurements performed before dietary interventionPopulation: In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed before dietary intervention.
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
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=27 Participants
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
|
|---|---|---|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
Glucose concentration at time 0 min
|
5.00 uM/mL
Standard Deviation 0.64
|
5.12 uM/mL
Standard Deviation 0.85
|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
Glucose concentration at time 30 min
|
8.19 uM/mL
Standard Deviation 1.60
|
7.67 uM/mL
Standard Deviation 1.91
|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
Glucose concentration at time 60 min
|
7.46 uM/mL
Standard Deviation 1.75
|
7.16 uM/mL
Standard Deviation 2.75
|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
Glucose concentration at time 120 min
|
4.92 uM/mL
Standard Deviation 0.76
|
5.01 uM/mL
Standard Deviation 1.12
|
PRIMARY outcome
Timeframe: Outcome measurement at baseline.Population: Systolic and diastolic blood pressure were measured before dietary intervention in a population with metabolic syndrome or with high risk for metabolic syndrome development.
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.
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=27 Participants
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
|
|---|---|---|
|
Systolic and Diastolic Blood Pressure
Systolic blood pressure
|
137.31 mm Hg
Standard Deviation 12.26
|
135.56 mm Hg
Standard Deviation 17.2
|
|
Systolic and Diastolic Blood Pressure
Diastolic blood pressure
|
82.19 mm Hg
Standard Deviation 5.73
|
82.11 mm Hg
Standard Deviation 9.65
|
PRIMARY outcome
Timeframe: Outcome measurement at baselinePopulation: 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).
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.
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=25 Participants
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
|
|---|---|---|
|
Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples
Acetic acid concentration
|
3.58 g/kg
Standard Deviation 2.03
|
2.70 g/kg
Standard Deviation 1.58
|
|
Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples
Propionic acid concentration
|
1.38 g/kg
Standard Deviation 0.9
|
0.91 g/kg
Standard Deviation 0.60
|
|
Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples
Butyric acid concentration
|
1.48 g/kg
Standard Deviation 0.98
|
0.97 g/kg
Standard Deviation 0.71
|
PRIMARY outcome
Timeframe: Outcome measure at baseline.Population: Triglyceride levels were measured in participants with metabolic syndrome or with high risk for metabolic syndrome development.
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).
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=27 Participants
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
|
|---|---|---|
|
Triglyceride Levels
|
1.62 mmol/L
Standard Deviation 1.06
|
1.91 mmol/L
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Outcome measurement after 4-week dietary interventionPopulation: 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).
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).
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=15 Participants
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.
|
Bread With Added Beta-glucans
n=25 Participants
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
|
|---|---|---|
|
Determination of Composition of Intestinal Microbiota From Fecal Samples
Clostridium coccoides group (cluster XIVa)
|
52.99 % of bacteria
Standard Deviation 18.88
|
47.22 % of bacteria
Standard Deviation 21.95
|
|
Determination of Composition of Intestinal Microbiota From Fecal Samples
Bacteroides - Prevotella group
|
8.89 % of bacteria
Standard Deviation 5.70
|
10.88 % of bacteria
Standard Deviation 8.80
|
|
Determination of Composition of Intestinal Microbiota From Fecal Samples
Clostridium leptum group (cluster IV)
|
30.38 % of bacteria
Standard Deviation 11.78
|
26.41 % of bacteria
Standard Deviation 14.96
|
|
Determination of Composition of Intestinal Microbiota From Fecal Samples
Enterobacteriaceae group
|
1.58 % of bacteria
Standard Deviation 3.59
|
0.79 % of bacteria
Standard Deviation 1.33
|
|
Determination of Composition of Intestinal Microbiota From Fecal Samples
Bifidobacterium genus
|
0.56 % of bacteria
Standard Deviation 0.58
|
1.07 % of bacteria
Standard Deviation 1.41
|
|
Determination of Composition of Intestinal Microbiota From Fecal Samples
Lactobacillus genus
|
0.10 % of bacteria
Standard Deviation 0.31
|
0.09 % of bacteria
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Outcome measurement after 4-week dietary interventionPopulation: 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.
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.
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=25 Participants
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
|
|---|---|---|
|
Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples
Butyric acid concentration
|
1.61 g/kg
Standard Deviation 2.09
|
1.12 g/kg
Standard Deviation 0.77
|
|
Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples
Acetic acid concentration
|
2.08 g/kg
Standard Deviation 1.03
|
2.93 g/kg
Standard Deviation 1.74
|
|
Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples
Propionic acid concentration
|
1.52 g/kg
Standard Deviation 2.50
|
1.30 g/kg
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Outcome measurement after 4-week dietary interventionPopulation: LDL-cholesterol levels were determined in both experimental groups.
LDL-cholesterol levels were determined after intervention
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=27 Participants
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
|
|---|---|---|
|
LDL-cholesterol Levels
|
4.02 mmol/L
Standard Deviation 0.66
|
3.89 mmol/L
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Outcome measurement after 4-week dietary interventionPopulation: HDL-cholesterol levels were determined after diet intervention in participants with metabolic syndrome or with high risk for metabolic syndrome development.
HDL-cholesterol levels were determined after diet intervention.
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=27 Participants
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
|
|---|---|---|
|
HDL-cholesterol Levels
|
1.47 mmol/L
Standard Deviation 0.44
|
1.30 mmol/L
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Outcome measure after 4-week dietary intervention.Population: Triglyceride levels were measured in participants with metabolic syndrome or with high risk for metabolic syndrome development.
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).
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=27 Participants
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
|
|---|---|---|
|
Triglyceride Levels
|
1.50 mmol/L
Standard Deviation 0.65
|
1.72 mmol/L
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Outcome measurement after 4-week dietary interventionPopulation: Total cholesterol levels were determined before diet intervention in both experimental groups.
After the intervention, total cholesterol levels were determined.
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=27 Participants
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
|
|---|---|---|
|
Total Cholesterol Levels
|
5.96 mmol/L
Standard Deviation 0.85
|
5.54 mmol/L
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Outcome OGTT measurements performed after 4-week dietary interventionPopulation: In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed after dietary intervention.
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
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=27 Participants
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
|
|---|---|---|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
Glucose concentration at time 60 min
|
7.26 uM/mL
Standard Deviation 3.39
|
6.81 uM/mL
Standard Deviation 2.80
|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
Glucose concentration at time 120 min
|
4.41 uM/mL
Standard Deviation 1.98
|
5.29 uM/mL
Standard Deviation 2.74
|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
Glucose concentration at time 0 min
|
5.16 uM/mL
Standard Deviation 0.71
|
4.98 uM/mL
Standard Deviation 1.28
|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
Glucose concentration at time 30 min
|
7.86 uM/mL
Standard Deviation 3.14
|
6.81 uM/mL
Standard Deviation 2.80
|
SECONDARY outcome
Timeframe: Outcome OGTT measurements performed after 4-week dietary interventionPopulation: In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed after dietary intervention.
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
Outcome measures
| Measure |
Bread Without Added Beta-glucans
n=16 Participants
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.
|
Bread With Added Beta-glucans
n=27 Participants
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
|
|---|---|---|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)
Insulin concentration at time 120 min
|
43.5 uM/mL
Standard Deviation 33.07
|
56.34 uM/mL
Standard Deviation 48.07
|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)
Insulin concentration at time 0 min
|
9.27 uM/mL
Standard Deviation 3.65
|
10.10 uM/mL
Standard Deviation 5.64
|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)
Insulin concentration at time 30 min
|
47.07 uM/mL
Standard Deviation 33.61
|
53.16 uM/mL
Standard Deviation 29.05
|
|
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)
Insulin concentration at time 60 min
|
67.85 uM/mL
Standard Deviation 35.41
|
76.50 uM/mL
Standard Deviation 60.54
|
Adverse Events
Bread With Added Beta-glucans
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Bread Without Added Beta-glucans
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bread With Added Beta-glucans
n=28 participants at risk
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
|
Bread Without Added Beta-glucans
n=23 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28 • Number of events 1 • 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 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.
|
0.00%
0/23 • 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 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.
|
|
Investigations
Discomfort during OGTT analysis
|
0.00%
0/28 • 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 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.
|
13.0%
3/23 • Number of events 3 • 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 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place