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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT02288572
Study groupRoleWhat they receive
Lactobacillus plantarum PCS 26Active comparatorDosage: 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
PlaceboPlacebo comparatorOnly 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.

  1. 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)
  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.

  1. First posted11 Nov 2014 (estimated)
  2. Study startMay 2013
  3. Primary completionMar 2014
  4. Study completionMay 2014

Resources

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)
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

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.

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