Dyslipidemia, Hyperglycemia, Hypertension, Metabolic Syndrome, Obesity, Abdominal
Conditions
Keywords
Metabolic syndrome, 4 -week intervention, Randomised placebo controlled parallel study, Beta-glucans, Abdominal fat, Dyslipidemia, Insulin resistance, Hypertension, Gut Microbiota Composition, Oral Glucose Tolerance Test, Lipid Profile, Real-Time Polymerase Chain Reaction, Denaturating Gradient Gel Electrophoresis
Brief summary
The purpose of this study is to investigate if daily consumption of barley beta-glucans effect lipid and glucose metabolism and alter intestinal microbiota composition in participants with metabolic syndrome or with high risk for metabolic syndrome development. It is assumed that 4-week intervention with beta-glucans will improve some clinical signs of metabolic syndrome and alter composition of intestinal microbiota. Variation in microbiota composition will be investigated with emphasis on Bacteroidetes and Firmicutes ratio. Furthermore it is presupposed that consumption of beta-glucans will stimulate growth of beneficial intestinal bacteria from genus Lactobacillus and Bifidobacteria and consequently effect production of short chain fatty acids in population with metabolic syndrome. Moreover it is presupposed that 4-week consumption of beta-glucans will have influence on glucose metabolism and will consequently improve insulin resistance within people with metabolic syndrome or high risk for metabolic syndrome development. It is assumed that 4-week consumption of beta-glucans will improve specific plasma lipid content in population with metabolic syndrome.
Detailed description
In study it will be investigated whether daily consumption of barley beta-glucans integrated in bread product effects lipid and glucose metabolism and alter the composition of intestinal microbiota in a population with metabolic syndrome or with high risk for metabolic syndrome development. 70 participants with metabolic syndrome will be enrolled in study. Participants will daily consume 200 g of bread with high amount of beta-glucans. Hypothesis: 1. 4- week consumption of beta-glucans alters composition of intestinal microbiota and changes ratio of bacteria from phylum Bacteroidetes and Firmicutes. Furthermore consumption of beta-glucans stimulates growth of beneficial intestinal bacteria from genus Lactobacillus and Bifidobacteria and consequently effects production of short chain fatty acids in population with metabolic syndrome. 2. 4- week consumption of beta-glucans has influence on glucose metabolism and consequently improves insulin resistance within people with metabolic syndrome. 3. 4 - week consumption of beta-glucans improves specific plasma lipid content in population with metabolic syndrome. Study will be designed as double blind, randomised, placebo controlled clinical trial and performed regarding to CONSORT 2010 recommendations for randomised clinical trials. Patient enrollment will be performed in several community health centres in Slovenia in association with family medicine doctors. Appropriate patients with metabolic syndrome or with high risk for metabolic development will be suggested to participate in clinical trial. Candidates will be suggested to participate in a two month study. If there will not be recruited enough participants for two month study they will be suggested for participation in one month study. Candidates interested in participating in study will be informed about study design and terms and conditions of study by main investigator. Study will be performed after successful recruitment of first 20 or more participants. Study will be performed three times, so that 70 participants will be recruited in complete study. Participants will consume bread with high beta-glucans content (around 3, 4 g beta-glucans per 100 g of bread) during 8 or 4 week period. Before beginning of study participants will have two week washout period without consuming any pre- and pro-biotics. They will remain their usual eating habits during study period except taking any antibiotics or pre- and pro-biotic. Participants will give blood and stool samples a day before intervention with barley beta-glucans. Blood sampling will involve oral glucose test for insulin resistance determination and sampling for specific lipid content determination. They will also have option to give a blood sample for genetic investigation of genes associated with lipid metabolism (apoE). Blood and stool sampling will be repeated day after intervention period. The same parameters as before intervention period except genetic analysis will be investigated. 72-hour dietary recall will be performed during intervention period individually to evaluate daily nutrient and energetic input of each participant.
Interventions
DIETARY_SUPPLEMENTBread with added beta-glucans
Participants will daily consume bread with high content of beta-glucans. They will approximately consume 6 g beta-glucans per day in 200 g of bread. Intervention period will be 4 weeks. Meanwhile the participants will remain their usual eating habits except consuming any pro- or pre-biotics
DIETARY_SUPPLEMENTPlacebo Comparator: Bread without added beta-glucans
Participants will daily consume placebo bread without any added beta-glucans (approximately 200 g per day). Intervention period will be 4 weeks. Meanwhile the participants will remain their usual eating habits except consuming any pro- or pre-biotics.
Sponsors
University of Ljubljana
University Medical Centre Ljubljana
Mlinotest Zivilska Industrija d.d.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
are parameters used for metabolic syndrome determination according to International Diabetes Federation (IDF) consensus worldwide definition of Metabolic Syndrome: Participant must have central obesity: defined as waist circumference ≥ 80 cm for European woman and ≥ 94 cm for European men. Beside central obesity candidates participating in this study must have total cholesterol concentration ≥ 5 mmol/l before entering the study. Plus any two of the following four factors: * HDL-cholesterol content: man ≤ 1,03 mmol/, women ≤ 1,23 mmol/l * Triglycerides content ≥ 1,7 mmol/l * Fasting blood glucose ≥ 5,6 mmol/l * Hypertension: systolic blood pressure ≥ 130 mm Hg and diastolic blood pressure ≥ 85 mm Hg If participant will have diagnosed metabolic syndrome and meet age criteria will be included in study.
Exclusion criteria
* Diabetes type II * Thyroid disorder * Kidney disorder * Antibiotic treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride Levels | Outcome measure at baseline. | 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). |
| Total Cholesterol Levels | Baseline outcome measurement | Before the intervention, total cholesterol levels were determined. |
| HDL-cholesterol Levels | Baseline measurement | HDL-cholesterol levels were determined before diet intervention. |
| LDL-cholesterol Levels | Baseline measurement | LDL-cholesterol levels were determined before intervention |
| Determination of Composition of Intestinal Microbiota From Fecal Samples | Outcome measurement at baseline | 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). |
| Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) | OGTT measurements 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 |
| Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) | Outcome OGTT measurements 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 |
| Systolic and Diastolic Blood Pressure | Outcome measurement at baseline. | 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. |
| Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Outcome measurement at baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Outcome measurement after 4-week dietary intervention | 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. |
| LDL-cholesterol Levels | Outcome measurement after 4-week dietary intervention | LDL-cholesterol levels were determined after intervention |
| HDL-cholesterol Levels | Outcome measurement after 4-week dietary intervention | HDL-cholesterol levels were determined after diet intervention. |
| Triglyceride Levels | Outcome measure after 4-week dietary intervention. | 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). |
| Total Cholesterol Levels | Outcome measurement after 4-week dietary intervention | After the intervention, total cholesterol levels were determined. |
| Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) | Outcome OGTT measurements performed after 4-week 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 |
| Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) | Outcome OGTT measurements performed after 4-week 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 |
| Determination of Composition of Intestinal Microbiota From Fecal Samples | Outcome measurement after 4-week dietary intervention | 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). |
Countries
Slovenia
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. 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 | 27 |
| 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). Intervention period will be 4 weeks. Meanwhile, the participants remained their usual eating habits except consuming any pro- or pre-biotics. | 16 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | discomfort during OGTT | 0 | 3 |
| Overall Study | Lost to Follow-up | 1 | 4 |
Baseline characteristics
| Characteristic | Bread With Added Beta-glucans | Bread Without Added Beta-glucans | Total |
|---|---|---|---|
| Age, Continuous | 50.93 years STANDARD_DEVIATION 7.4 | 54.00 years STANDARD_DEVIATION 8.07 | 52.07 years STANDARD_DEVIATION 7.71 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 20 Participants | 13 Participants | 33 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 23 |
| other Total, other adverse events | 0 / 28 | 0 / 23 |
| serious Total, serious adverse events | 1 / 28 | 3 / 23 |
Outcome results
Primary
Determination of Composition of Intestinal Microbiota From Fecal Samples
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bread With Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Clostridium leptum group (cluster IV) | 28.22 % of bacteria | Standard Deviation 11.33 |
| Bread With Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Enterobacteriaceae group | 1.75 % of bacteria | Standard Deviation 5.65 |
| Bread With Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Clostridium coccoides group (cluster XIVa) | 51.02 % of bacteria | Standard Deviation 22.91 |
| Bread With Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Bifidobacterium genus | 0.62 % of bacteria | Standard Deviation 0.91 |
| Bread With Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Lactobacillus genus | 0.03 % of bacteria | Standard Deviation 0.06 |
| Bread With Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Bacteroides - Prevotella group | 7.95 % of bacteria | Standard Deviation 6.61 |
| Bread Without Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Lactobacillus genus | 0.31 % of bacteria | Standard Deviation 0.06 |
| Bread Without Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Bacteroides - Prevotella group | 6.94 % of bacteria | Standard Deviation 3.57 |
| Bread Without Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Bifidobacterium genus | 0.54 % of bacteria | Standard Deviation 1.15 |
| Bread Without Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Clostridium leptum group (cluster IV) | 29.58 % of bacteria | Standard Deviation 11.9 |
| Bread Without Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Clostridium coccoides group (cluster XIVa) | 58.03 % of bacteria | Standard Deviation 23.79 |
| Bread Without Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Enterobacteriaceae group | 1.81 % of bacteria | Standard Deviation 5.46 |
Primary
Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bread With Added Beta-glucans | Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Acetic acid concentration | 2.70 g/kg | Standard Deviation 1.58 |
| Bread With Added Beta-glucans | Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Propionic acid concentration | 0.91 g/kg | Standard Deviation 0.6 |
| Bread With Added Beta-glucans | Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Butyric acid concentration | 0.97 g/kg | Standard Deviation 0.71 |
| Bread Without Added Beta-glucans | Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Acetic acid concentration | 3.58 g/kg | Standard Deviation 2.03 |
| Bread Without Added Beta-glucans | Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Propionic acid concentration | 1.38 g/kg | Standard Deviation 0.9 |
| Bread Without Added Beta-glucans | Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Butyric acid concentration | 1.48 g/kg | Standard Deviation 0.98 |
Primary
HDL-cholesterol Levels
HDL-cholesterol levels were determined before diet intervention.
Time frame: Baseline measurement
Population: HDL-cholesterol levels were determined before diet intervention in both experimental groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bread With Added Beta-glucans | HDL-cholesterol Levels | 1.31 mmol/L | Standard Deviation 0.44 |
| Bread Without Added Beta-glucans | HDL-cholesterol Levels | 1.51 mmol/L | Standard Deviation 0.52 |
Primary
LDL-cholesterol Levels
LDL-cholesterol levels were determined before intervention
Time frame: Baseline measurement
Population: LDL-cholesterol levels were determined in both experimental groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bread With Added Beta-glucans | LDL-cholesterol Levels | 3.99 mmol/L | Standard Deviation 0.89 |
| Bread Without Added Beta-glucans | LDL-cholesterol Levels | 4.02 mmol/L | Standard Deviation 0.91 |
Primary
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
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
Population: In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed before dietary intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) | Glucose concentration at time 0 min | 5.12 uM/mL | Standard Deviation 0.85 |
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) | Glucose concentration at time 60 min | 7.16 uM/mL | Standard Deviation 2.75 |
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) | Glucose concentration at time 30 min | 7.67 uM/mL | Standard Deviation 1.91 |
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) | Glucose concentration at time 120 min | 5.01 uM/mL | Standard Deviation 1.12 |
| Bread Without Added Beta-glucans | 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 |
| Bread Without Added Beta-glucans | 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 |
| Bread Without Added Beta-glucans | 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 1.6 |
| Bread Without Added Beta-glucans | 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 |
Primary
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)
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
Population: In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed before dietary intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) | Insulin concentration at time 0 min | 8.85 uM/mL | Standard Deviation 5.87 |
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) | Insulin concentration at time 30 min | 50.01 uM/mL | Standard Deviation 36.05 |
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) | Insulin concentration at time 60 min | 64.95 uM/mL | Standard Deviation 50.55 |
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) | Insulin concentration at time 120 min | 50.15 uM/mL | Standard Deviation 39.92 |
| Bread Without Added Beta-glucans | 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 |
| Bread Without Added Beta-glucans | 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 |
| Bread Without Added Beta-glucans | 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 |
| Bread Without Added Beta-glucans | 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 |
Primary
Systolic and Diastolic Blood Pressure
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.
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bread With Added Beta-glucans | Systolic and Diastolic Blood Pressure | Systolic blood pressure | 135.56 mm Hg | Standard Deviation 17.2 |
| Bread With Added Beta-glucans | Systolic and Diastolic Blood Pressure | Diastolic blood pressure | 82.11 mm Hg | Standard Deviation 9.65 |
| Bread Without Added Beta-glucans | Systolic and Diastolic Blood Pressure | Systolic blood pressure | 137.31 mm Hg | Standard Deviation 12.26 |
| Bread Without Added Beta-glucans | Systolic and Diastolic Blood Pressure | Diastolic blood pressure | 82.19 mm Hg | Standard Deviation 5.73 |
Primary
Total Cholesterol Levels
Before the intervention, total cholesterol levels were determined.
Time frame: Baseline outcome measurement
Population: Total cholesterol levels were determined before diet intervention in both experimental groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bread With Added Beta-glucans | Total Cholesterol Levels | 5.8 mmol/L | Standard Deviation 1.01 |
| Bread Without Added Beta-glucans | Total Cholesterol Levels | 5.9 mmol/L | Standard Deviation 1.13 |
Primary
Triglyceride Levels
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.
Population: Triglyceride levels were measured in participants with metabolic syndrome or with high risk for metabolic syndrome development.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bread With Added Beta-glucans | Triglyceride Levels | 1.91 mmol/L | Standard Deviation 1.23 |
| Bread Without Added Beta-glucans | Triglyceride Levels | 1.62 mmol/L | Standard Deviation 1.06 |
Secondary
Determination of Composition of Intestinal Microbiota From Fecal Samples
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bread With Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Bacteroides - Prevotella group | 10.88 % of bacteria | Standard Deviation 8.8 |
| Bread With Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Clostridium leptum group (cluster IV) | 26.41 % of bacteria | Standard Deviation 14.96 |
| Bread With Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Clostridium coccoides group (cluster XIVa) | 47.22 % of bacteria | Standard Deviation 21.95 |
| Bread With Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Enterobacteriaceae group | 0.79 % of bacteria | Standard Deviation 1.33 |
| Bread With Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Bifidobacterium genus | 1.07 % of bacteria | Standard Deviation 1.41 |
| Bread With Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Lactobacillus genus | 0.09 % of bacteria | Standard Deviation 0.36 |
| Bread Without Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Bifidobacterium genus | 0.56 % of bacteria | Standard Deviation 0.58 |
| Bread Without Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Bacteroides - Prevotella group | 8.89 % of bacteria | Standard Deviation 5.7 |
| Bread Without Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Enterobacteriaceae group | 1.58 % of bacteria | Standard Deviation 3.59 |
| Bread Without Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Clostridium leptum group (cluster IV) | 30.38 % of bacteria | Standard Deviation 11.78 |
| Bread Without Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Lactobacillus genus | 0.10 % of bacteria | Standard Deviation 0.31 |
| Bread Without Added Beta-glucans | Determination of Composition of Intestinal Microbiota From Fecal Samples | Clostridium coccoides group (cluster XIVa) | 52.99 % of bacteria | Standard Deviation 18.88 |
Secondary
Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bread With Added Beta-glucans | Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Acetic acid concentration | 2.93 g/kg | Standard Deviation 1.74 |
| Bread With Added Beta-glucans | Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Propionic acid concentration | 1.30 g/kg | Standard Deviation 0.9 |
| Bread With Added Beta-glucans | Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Butyric acid concentration | 1.12 g/kg | Standard Deviation 0.77 |
| Bread Without Added Beta-glucans | Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Acetic acid concentration | 2.08 g/kg | Standard Deviation 1.03 |
| Bread Without Added Beta-glucans | Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Propionic acid concentration | 1.52 g/kg | Standard Deviation 2.5 |
| Bread Without Added Beta-glucans | Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples | Butyric acid concentration | 1.61 g/kg | Standard Deviation 2.09 |
Secondary
HDL-cholesterol Levels
HDL-cholesterol levels were determined after diet intervention.
Time frame: Outcome measurement after 4-week dietary intervention
Population: HDL-cholesterol levels were determined after diet intervention in participants with metabolic syndrome or with high risk for metabolic syndrome development.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bread With Added Beta-glucans | HDL-cholesterol Levels | 1.30 mmol/L | Standard Deviation 0.43 |
| Bread Without Added Beta-glucans | HDL-cholesterol Levels | 1.47 mmol/L | Standard Deviation 0.44 |
Secondary
LDL-cholesterol Levels
LDL-cholesterol levels were determined after intervention
Time frame: Outcome measurement after 4-week dietary intervention
Population: LDL-cholesterol levels were determined in both experimental groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bread With Added Beta-glucans | LDL-cholesterol Levels | 3.89 mmol/L | Standard Deviation 0.89 |
| Bread Without Added Beta-glucans | LDL-cholesterol Levels | 4.02 mmol/L | Standard Deviation 0.66 |
Secondary
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
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
Population: In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed after dietary intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) | Glucose concentration at time 0 min | 4.98 uM/mL | Standard Deviation 1.28 |
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) | Glucose concentration at time 30 min | 6.81 uM/mL | Standard Deviation 2.8 |
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) | Glucose concentration at time 60 min | 6.81 uM/mL | Standard Deviation 2.8 |
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) | Glucose concentration at time 120 min | 5.29 uM/mL | Standard Deviation 2.74 |
| Bread Without Added Beta-glucans | 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 |
| Bread Without Added Beta-glucans | 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 |
| Bread Without Added Beta-glucans | 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 |
| Bread Without Added Beta-glucans | 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 |
Secondary
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)
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
Population: In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed after dietary intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) | Insulin concentration at time 0 min | 10.10 uM/mL | Standard Deviation 5.64 |
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) | Insulin concentration at time 30 min | 53.16 uM/mL | Standard Deviation 29.05 |
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) | Insulin concentration at time 60 min | 76.50 uM/mL | Standard Deviation 60.54 |
| Bread With Added Beta-glucans | Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) | Insulin concentration at time 120 min | 56.34 uM/mL | Standard Deviation 48.07 |
| Bread Without Added Beta-glucans | 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 |
| Bread Without Added Beta-glucans | 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 |
| Bread Without Added Beta-glucans | 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 |
| Bread Without Added Beta-glucans | 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 |
Secondary
Total Cholesterol Levels
After the intervention, total cholesterol levels were determined.
Time frame: Outcome measurement after 4-week dietary intervention
Population: Total cholesterol levels were determined before diet intervention in both experimental groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bread With Added Beta-glucans | Total Cholesterol Levels | 5.54 mmol/L | Standard Deviation 0.9 |
| Bread Without Added Beta-glucans | Total Cholesterol Levels | 5.96 mmol/L | Standard Deviation 0.85 |
Secondary
Triglyceride Levels
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.
Population: Triglyceride levels were measured in participants with metabolic syndrome or with high risk for metabolic syndrome development.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bread With Added Beta-glucans | Triglyceride Levels | 1.72 mmol/L | Standard Deviation 1.04 |
| Bread Without Added Beta-glucans | Triglyceride Levels | 1.50 mmol/L | Standard Deviation 0.65 |