Metabolic Syndrome XPhase 2NCT02288572
Probiotic Bacteria in Prevention of the Metabolic Syndrome
A Phase 2 study testing Lactobacillus plantarum PCS 26 in people with Metabolic Syndrome X, run by University Maribor.
Trial summary
The metabolic syndrome is increasing worldwide, including developing countries. The metabolic syndrome is composed of clinical expressed symptoms as central obesity, high blood pressure, raised fasting plasma glucose or diagnosed diabetes, low HDL, and raised serum triglycerides. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Lactobacillus plantarum PCS 26
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- May 2013to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- visceral obesity and at least two of other components: raised fasting serum glucose or known diabetes type 2; raised fasting serum triglycerides; raised fasting serum cholesterol; raised fasting serum LDL and low fasting serum HDL; high blood pressure, more than 130/85 mmHg.
Who cannot join
- planned invasive procedure or surgery (whole body);
- planned surgery in mouth cavity;
- weakened immune system or taking immunosuppressives;
- diagnosed inflammatory bowel disease;
- known or diagnosed lactose intolerance.
About this study
Official title: Mechanisms of Action of Probiotic and Protective Bacteria PCS 20, PCS 26, and LGG in Prevention of the Metabolic Syndrome
The metabolic syndrome is increasing worldwide, including developing countries. The metabolic syndrome is composed of clinical expressed symptoms as central obesity, high blood pressure, raised fasting plasma glucose or diagnosed diabetes, low HDL, and raised serum triglycerides. All those components together or independently contribute to the development of cardiovascular diseases, which are the leading cause of death in the modern world. The results from previous studies have shown that probiotic bacteria have an influence on health improvement, and can exert positive effects on diseases as diabetes, high blood pressure, dyslipidemia and low-grade inflammation, which are all components of the metabolic syndrome. The objectives of this study were to investigate which of probiotic strains Lactobacillus plantarum PCS 20, Lactobacillus plantarum PCS 26 in Lactobacillus rhamnosus GG exert positive effects in the cascade of molecular reactions at the level of small intestines, at remodeling of monocytes/macrophages and adipocytes in human cell model of non-cancerous origin, and to provide scientific explanation of mechanisms of possible multi-leveled activity of selected probiotic strains in patients with metabolic syndrome. For this purpose, the investigators divided this research into two parts. The first part consisted of pre-clinical in-vitro laboratory study. It examined the mechanisms of actions of probiotic cultures with the use of functional cell models of non-cancerous origin, more specifically, with the use of cell lines of human intestinal epithelium, human monocytes/macrophages and human visceral preadipocytes. In in-vitro laboratory study, the investigators demonstrated that probiotic strain Lactobacillus plantarum PCS 26 exerts positive effects, which could help to relieve the particular components of the syndrome in the host with metabolic syndrome. The second part of the research consisted of prospective, double-blind and placebo-controlled in-vivo pilot clinical study, which included 16 volunteers with the metabolic syndrome. Results have shown that probiotic strain Lactobacillus plantarum PCS 26 exerts positive effects on reduction of waist circumference, on lowering of serum cholesterol concentration, and on maintenance of serum adiponectin levels. Those effects together can contribute to the alleviation of the metabolic syndrome, especially in terms of clinical manifestation and risks in relation to cardiovascular diseases.
- Conditions
- Metabolic Syndrome X
- Being tested
- Lactobacillus plantarum PCS 26, Placebo
- Keywords
- metabolic syndrome X, obesity, insulin resistance, dyslipidemia, probiotic bacteria
- Medical subject headings
- Metabolic Syndrome, Obesity, Insulin Resistance, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum PCS 26Dietary supplement
Taking dietary supplement on a daily basis which corresponds to 1.000.000.000 CFU of Lactobacillus plantarum PCS 26 per day for 3 months.
PlaceboDietary supplement
Taking dietary supplement on a daily basis for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus plantarum PCS 26 | Active comparator | Dosage: 1.000.000.000 Colony Forming Units (CFU) per day in powdery form for 3 months Vehicle: 70 % glucose, 15 % powder milk, 15 % whey Receives: Dietary Supplement: Lactobacillus plantarum PCS 26 |
| Placebo | Placebo comparator | Only vehicle components in powdery form for 3 months Vehicle: 70 % glucose, 15 % powder milk, 15 % whey Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum lipids concentrations after daily consumption of dietary supplement in patients with the metabolic syndrome
Serum total cholesterol, triglycerides, LDL and HDL concentrations
Measured: 3 months
Secondary outcomes (1)
Measures of body composition after daily consumption of dietary supplement in patients with the metabolic syndrome
Body weight, body mass without body fat, total body fat, body volume, muscle mass, body mass index, visceral fat, subcutaneous fat, blood pressure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Maribor
- Sponsor type
- University, hospital or other
- Collaborators
- Slovenian Research Agency
- Responsible party
- Principal investigator, Mario Gorenjak, University Maribor
- Investigators
- Pavel Skok, DSc, MD, Study chair, University Medical Centre MariborMario Gorenjak, DSc, MBioinf, BHSc, Principal investigator, Faculty of Medicine, University of Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288572
- Sponsor's protocol ID
- MGPS001
- Status last verified
- Nov 2014
- First submitted
- 2 Nov 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Action of Probiotic and Protective Bacteria PCS 20, PCS 26, and LGG in Prevention of the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02288572
- Acronym / sponsor ID
- MGPS001
- Conditions
- Metabolic Syndrome X
- Keywords
- metabolic syndrome X, obesity, insulin resistance, dyslipidemia, probiotic bacteria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University MariborUniversity, hospital or other
- Collaborators
- Slovenian Research Agency
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The metabolic syndrome is increasing worldwide, including developing countries. The metabolic syndrome is composed of clinical expressed symptoms as central obesity, high blood pressure, raised fasting plasma glucose or diagnosed diabetes, low HDL, and raised serum triglycerides. All those components together or independently contribute to the development of cardiovascular diseases, which are the leading cause of death in the modern world. The results from previous studies have shown that probiotic bacteria have an influence on health improvement, and can exert positive effects on diseases as diabetes, high blood pressure, dyslipidemia and low-grade inflammation, which are all components of the metabolic syndrome. The objectives of this study were to investigate which of probiotic strains Lactobacillus plantarum PCS 20, Lactobacillus plantarum PCS 26 in Lactobacillus rhamnosus GG exert positive effects in the cascade of molecular reactions at the level of small intestines, at remodeling of monocytes/macrophages and adipocytes in human cell model of non-cancerous origin, and to provide scientific explanation of mechanisms of possible multi-leveled activity of selected probiotic strains in patients with metabolic syndrome. For this purpose, the investigators divided this research into two parts. The first part consisted of pre-clinical in-vitro laboratory study. It examined the mechanisms of actions of probiotic cultures with the use of functional cell models of non-cancerous origin, more specifically, with the use of cell lines of human intestinal epithelium, human monocytes/macrophages and human visceral preadipocytes. In in-vitro laboratory study, the investigators demonstrated that probiotic strain Lactobacillus plantarum PCS 26 exerts positive effects, which could help to relieve the particular components of the syndrome in the host with metabolic syndrome. The second part of the research consisted of prospective, double-blind and placebo-controlled in-vivo pilot clinical study, which included 16 volunteers with the metabolic syndrome. Results have shown that probiotic strain Lactobacillus plantarum PCS 26 exerts positive effects on reduction of waist circumference, on lowering of serum cholesterol concentration, and on maintenance of serum adiponectin levels. Those effects together can contribute to the alleviation of the metabolic syndrome, especially in terms of clinical manifestation and risks in relation to cardiovascular diseases.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus plantarum PCS 26 | Active comparator | Dietary Supplement: Lactobacillus plantarum PCS 26Dosage: 1.000.000.000 Colony Forming Units (CFU) per day in powdery form for 3 months Vehicle: 70 % glucose, 15 % powder milk, 15 % whey |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOnly vehicle components in powdery form for 3 months Vehicle: 70 % glucose, 15 % powder milk, 15 % whey |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- visceral obesity and at least two of other components: raised fasting serum glucose or known diabetes type 2; raised fasting serum triglycerides; raised fasting serum cholesterol; raised fasting serum LDL and low fasting serum HDL; high blood pressure, more than 130/85 mmHg.
Key exclusion criteria (5 listed)
- planned invasive procedure or surgery (whole body);
- planned surgery in mouth cavity;
- weakened immune system or taking immunosuppressives;
- diagnosed inflammatory bowel disease;
- known or diagnosed lactose intolerance.
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 |
|---|---|---|
| Lactobacillus plantarum PCS 26Taking dietary supplement on a daily basis which corresponds to 1.000.000.000 CFU of Lactobacillus plantarum PCS 26 per day for 3 months. | Dietary supplement | Lactobacillus plantarum PCS 26 |
| PlaceboTaking dietary supplement on a daily basis for 3 months. | Dietary supplement | Placebo |
Primary outcome
Serum lipids concentrations after daily consumption of dietary supplement in patients with the metabolic syndrome
Time frame: 3 months
Serum total cholesterol, triglycerides, LDL and HDL concentrations
1 secondary outcome
Measures of body composition after daily consumption of dietary supplement in patients with the metabolic syndrome
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
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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.
Pavel Skok, DSc, MD study chair
University Medical Centre Maribor
Mario Gorenjak, DSc, MBioinf, BHSc principal investigator
Faculty of Medicine, University of Maribor
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactobacillus plantarum PCS 26 in people with Metabolic Syndrome X, run by University Maribor.
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 1 inclusion and 5 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 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum lipids concentrations after daily consumption of dietary supplement in patients with the metabolic syndrome (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Nov 2014.