Metabolic SyndromeNCT02041104
Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid Metabolism
A study testing Bread with added beta-glucans in people with Metabolic Syndrome and Dyslipidemia, run by Mlinotest Zivilska Industrija d.d. at 3 sites in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Metabolic Syndrome, Dyslipidemia, Obesity, Abdominal
- What is being tested?
- Bread with added beta-glucans
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 3 sitesSlovenia
- Study dates
- Feb 2014to Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Diabetes type II
- Thyroid disorder
- Kidney disorder
- Antibiotic treatment
Trial locations and contacts
3 sites in 1 country.
Slovenia3 sites
Community Health Center Ajdovscina
Ajdovščina, 5270
Community Healt Center Ljubljana
Ljubljana, 1000
Community Health Center Franca Amrozica Postojna
Postojna, 6230
About this study
Official title: Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid Metabolism in a Population With Metabolic Syndrome
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.
Read the 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:
- 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.
- 4- week consumption of beta-glucans has influence on glucose metabolism and consequently improves insulin resistance within people with metabolic syndrome.
- 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.
- Being tested
- Bread with added beta-glucans, Placebo Comparator: Bread without added beta-glucans
- 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
- Medical subject headings
- Metabolic Syndrome, Dyslipidemias, Obesity, Abdominal, Hyperglycemia, Hypertension, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bread with added beta-glucansDietary 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
Placebo Comparator: Bread without added beta-glucansDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Bread with added beta-glucans |
| Bread without added beta-glucans | Placebo comparator | Placebo bread without added barley beta-glucans in testing product. Receives: Dietary Supplement: Placebo Comparator: Bread without added beta-glucans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cholesterol Levels
Before the intervention, total cholesterol levels were determined.
Measured: Baseline outcome measurement
HDL-cholesterol Levels
HDL-cholesterol levels were determined before diet intervention.
Measured: Baseline measurement
LDL-cholesterol Levels
LDL-cholesterol levels were determined before intervention
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Outcome measure at baseline.
Secondary outcomes (8)
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).
Measured: Outcome measurement after 4-week dietary intervention
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.
Measured: Outcome measurement after 4-week dietary intervention
LDL-cholesterol Levels
LDL-cholesterol levels were determined after intervention
Measured: Outcome measurement after 4-week dietary intervention
HDL-cholesterol Levels
HDL-cholesterol levels were determined after diet intervention.
Measured: 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).
Measured: Outcome measure after 4-week dietary intervention.
Total Cholesterol Levels
After the intervention, total cholesterol levels were determined.
Measured: 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
Measured: 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
Measured: Outcome OGTT measurements performed after 4-week dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mlinotest Zivilska Industrija d.d.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Ljubljana, University Medical Centre Ljubljana
- Responsible party
- Sponsor
- Investigators
- Ana Velikonja, PhD student, Principal investigator, Mlinotest d.d. Zivilska IndustrijaRok Orel, M.D., D.Sc., Study director, University Medical Centre LjubljanaGorazd Avgustin, UP, Study director, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041104
- Sponsor's protocol ID
- MLINOTEST/618-001
- Status last verified
- Feb 2019
- First submitted
- 15 Jan 2014
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
(1) Izydorczyk MS,Dexter JE. Barley beta-glucans and arabinoxylans: Molecular structure, physicochemical properties, and uses in food products-a Review. Food Research International 41: 850-868, 2008
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid Metabolism in a Population With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02041104
- Acronym / sponsor ID
- MLINOTEST/618-001
- Keywords
- Metabolic syndrome, 4 -week intervention, Randomised placebo controlled parallel study, Beta-glucans, Abdominal fat, Dyslipidemia, Insulin resistance, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Mlinotest Zivilska Industrija d.d.Industry (pharma, biotech, devices)
- Collaborators
- University of Ljubljana, University Medical Centre Ljubljana
- Study start
- Feb 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 4- week consumption of beta-glucans has influence on glucose metabolism and consequently improves insulin resistance within people with metabolic syndrome.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bread with added beta-glucans | Experimental | Dietary Supplement: Bread with added beta-glucansExperimental 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. |
| Bread without added beta-glucans | Placebo comparator | Dietary Supplement: Placebo Comparator: Bread without added beta-glucansPlacebo bread without added barley beta-glucans in testing product. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Diabetes type II
- Thyroid disorder
- Kidney disorder
- Antibiotic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bread with added beta-glucansParticipants will daily consume bread with high content of beta-glucans. They will approximately consume 6 g beta-glucans per day in 200 g of bread. Intervention period will be 4 weeks. Meanwhile the participants will remain their usual eating habits except consuming any pro- or pre-biotics | Dietary supplement | Bread with added beta-glucans |
| Placebo Comparator: Bread without added beta-glucansParticipants 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. | Dietary supplement | Bread without added beta-glucans |
Primary outcome
Total Cholesterol Levels
Time frame: Baseline outcome measurement
Before the intervention, total cholesterol levels were determined.
HDL-cholesterol Levels
Time frame: Baseline measurement
HDL-cholesterol levels were determined before diet intervention.
LDL-cholesterol Levels
Time frame: Baseline measurement
LDL-cholesterol levels were determined before intervention
Determination of Composition of Intestinal Microbiota From Fecal Samples
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Triglyceride Levels
Time frame: 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).
8 secondary outcomes
Determination of Composition of Intestinal Microbiota From Fecal Samples
Time frame: Outcome measurement after 4-week dietary intervention
Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples
Time frame: Outcome measurement after 4-week dietary intervention
LDL-cholesterol Levels
Time frame: Outcome measurement after 4-week dietary intervention
HDL-cholesterol Levels
Time frame: Outcome measurement after 4-week dietary intervention
Triglyceride Levels
Time frame: Outcome measure after 4-week dietary intervention.
Total Cholesterol Levels
Time frame: Outcome measurement after 4-week dietary intervention
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
Time frame: Outcome OGTT measurements performed after 4-week dietary intervention
Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)
Time frame: Outcome OGTT measurements performed after 4-week dietary intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Velikonja, PhD student principal investigator
Mlinotest d.d. Zivilska Industrija
Rok Orel, M.D., D.Sc. study director
University Medical Centre Ljubljana
Gorazd Avgustin, UP study director
University of Ljubljana
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bread with added beta-glucans in people with Metabolic Syndrome and Dyslipidemia, run by Mlinotest Zivilska Industrija d.d. at 3 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol Levels (time frame: Baseline outcome measurement). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02041104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.