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| Name | Class |
|---|---|
| University of Ljubljana | OTHER |
| University Medical Centre Ljubljana | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bread with added beta-glucans | Experimental | 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. Their molecular structure enable beta-glucans their functional action that mostly depends of their viscosity and solubility (1). 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. |
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| Bread without added beta-glucans | Placebo Comparator | Placebo bread without added barley beta-glucans in testing product. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bread with added beta-glucans | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol Levels | Before the intervention, total cholesterol levels were determined. | Baseline outcome measurement |
| HDL-cholesterol Levels | HDL-cholesterol levels were determined before diet intervention. | Baseline measurement |
| LDL-cholesterol Levels | LDL-cholesterol levels were determined before intervention | Baseline measurement |
| 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). | Outcome measurement at baseline |
| 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 | OGTT measurements performed before dietary intervention |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Outcome measurement after 4-week dietary intervention |
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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:
If participant will have diagnosed metabolic syndrome and meet age criteria will be included in study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Velikonja, PhD student | Mlinotest d.d. Zivilska Industrija | Principal Investigator |
| Rok Orel, M.D., D.Sc. | University Medical Centre Ljubljana | Study Director |
| Gorazd Avgustin, UP | University of Ljubljana | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Health Center Ajdovscina | Ajdovščina | 5270 | Slovenia | |||
| Community Healt Center Ljubljana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | (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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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2018 | Sep 1, 2018 |
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| Placebo Comparator: Bread without added beta-glucans | Dietary Supplement | 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. |
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| Outcome OGTT measurements performed before dietary intervention |
| 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. | Outcome measurement at baseline. |
| 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. | Outcome measurement at baseline |
| 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). | Outcome measure at baseline. |
| 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. | Outcome measurement after 4-week dietary intervention |
| LDL-cholesterol Levels | LDL-cholesterol levels were determined after intervention | Outcome measurement after 4-week dietary intervention |
| HDL-cholesterol Levels | HDL-cholesterol levels were determined after diet intervention. | Outcome measurement after 4-week dietary intervention |
| 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). | Outcome measure after 4-week dietary intervention. |
| Total Cholesterol Levels | After the intervention, total cholesterol levels were determined. | Outcome measurement after 4-week dietary intervention |
| 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 | Outcome OGTT measurements performed after 4-week dietary intervention |
| 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 | Outcome OGTT measurements performed after 4-week dietary intervention |
| Ljubljana |
| 1000 |
| Slovenia |
| Community Health Center Franca Amrozica Postojna | Postojna | 6230 | Slovenia |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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The inclusion criteria for participants were as well diagnosed metabolic syndrome or high risk for metabolic syndrome development.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Cholesterol Levels | Before the intervention, total cholesterol levels were determined. | Total cholesterol levels were determined before diet intervention in both experimental groups. | Posted | Mean | Standard Deviation | mmol/L | Baseline outcome measurement |
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| Primary | HDL-cholesterol Levels | HDL-cholesterol levels were determined before diet intervention. | HDL-cholesterol levels were determined before diet intervention in both experimental groups. | Posted | Mean | Standard Deviation | mmol/L | Baseline measurement |
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| Primary | LDL-cholesterol Levels | LDL-cholesterol levels were determined before intervention | LDL-cholesterol levels were determined in both experimental groups. | Posted | Mean | Standard Deviation | mmol/L | Baseline measurement |
| ||||||||||||||||||||||||||||||
| 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). | 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). | Posted | Mean | Standard Deviation | % of bacteria | Outcome measurement at baseline |
| ||||||||||||||||||||||||||||||
| 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 | In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed before dietary intervention. | Posted | Mean | Standard Deviation | uM/mL | OGTT measurements performed before dietary intervention |
| ||||||||||||||||||||||||||||||
| 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 | In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed before dietary intervention. | Posted | Mean | Standard Deviation | uM/mL | Outcome OGTT measurements performed before dietary intervention |
| ||||||||||||||||||||||||||||||
| 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. | Systolic and diastolic blood pressure were measured before dietary intervention in a population with metabolic syndrome or with high risk for metabolic syndrome development. | Posted | Mean | Standard Deviation | mm Hg | Outcome measurement at baseline. |
| ||||||||||||||||||||||||||||||
| 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. | 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). | Posted | Mean | Standard Deviation | g/kg | Outcome measurement at baseline |
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| 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). | Triglyceride levels were measured in participants with metabolic syndrome or with high risk for metabolic syndrome development. | Posted | Mean | Standard Deviation | mmol/L | Outcome measure at baseline. |
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| 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). | 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). | Posted | Mean | Standard Deviation | % of bacteria | Outcome measurement after 4-week dietary intervention |
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| 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. | 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. | Posted | Mean | Standard Deviation | g/kg | Outcome measurement after 4-week dietary intervention |
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| Secondary | LDL-cholesterol Levels | LDL-cholesterol levels were determined after intervention | LDL-cholesterol levels were determined in both experimental groups. | Posted | Mean | Standard Deviation | mmol/L | Outcome measurement after 4-week dietary intervention |
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| Secondary | HDL-cholesterol Levels | HDL-cholesterol levels were determined after diet intervention. | HDL-cholesterol levels were determined after diet intervention in participants with metabolic syndrome or with high risk for metabolic syndrome development. | Posted | Mean | Standard Deviation | mmol/L | Outcome measurement after 4-week dietary intervention |
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| 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). | Triglyceride levels were measured in participants with metabolic syndrome or with high risk for metabolic syndrome development. | Posted | Mean | Standard Deviation | mmol/L | Outcome measure after 4-week dietary intervention. |
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| Secondary | Total Cholesterol Levels | After the intervention, total cholesterol levels were determined. | Total cholesterol levels were determined before diet intervention in both experimental groups. | Posted | Mean | Standard Deviation | mmol/L | Outcome measurement after 4-week dietary intervention |
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| 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 | In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed after dietary intervention. | Posted | Mean | Standard Deviation | uM/mL | Outcome OGTT measurements performed after 4-week dietary intervention |
| ||||||||||||||||||||||||||||||
| 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 | In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed after dietary intervention. | Posted | Mean | Standard Deviation | uM/mL | Outcome OGTT measurements performed after 4-week dietary intervention |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 28 | 1 | 28 | 0 | 28 |
| EG001 | 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. | 0 | 23 | 3 | 23 | 0 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | After few days of dietary trial, diarrhea appear to one participant in test group consuming bread with added beta-glucans. |
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| Discomfort during OGTT analysis | Investigations | Non-systematic Assessment | Participants felt dizziness or sickness during first OGTT analysis. They refused to continue diet intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana Velikonja | Mlinotest d. d. | 0038651321785 | anaa.velikonja@gmail.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Aug 22, 2013 | Feb 21, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D050171 | Dyslipidemias |
| D056128 | Obesity, Abdominal |
| D006943 | Hyperglycemia |
| D006973 | Hypertension |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001939 | Bread |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| OG001 |
| 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. |
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| 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. |
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| 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. |
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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.
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| OG001 |
| 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. |
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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. |
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| OG001 |
| 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. |
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| OG001 |
| 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. |
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