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Probiotic Bacteria in Prevention of the Metabolic Syndrome

Primary Purpose

Metabolic Syndrome X

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lactobacillus plantarum PCS 26
Placebo
Sponsored by
University Maribor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome X focused on measuring metabolic syndrome X, obesity, insulin resistance, dyslipidemia, probiotic bacteria

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Lactobacillus plantarum PCS 26

    Placebo

    Arm Description

    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

    Only vehicle components in powdery form for 3 months Vehicle: 70 % glucose, 15 % powder milk, 15 % whey

    Outcomes

    Primary Outcome Measures

    Serum lipids concentrations after daily consumption of dietary supplement in patients with the metabolic syndrome
    Serum total cholesterol, triglycerides, LDL and HDL concentrations

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    November 2, 2014
    Last Updated
    November 6, 2014
    Sponsor
    University Maribor
    Collaborators
    Slovenian Research Agency
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02288572
    Brief Title
    Probiotic Bacteria in Prevention of the Metabolic Syndrome
    Official Title
    Mechanisms of Action of Probiotic and Protective Bacteria PCS 20, PCS 26, and LGG in Prevention of the Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    May 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Maribor
    Collaborators
    Slovenian Research Agency

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome X
    Keywords
    metabolic syndrome X, obesity, insulin resistance, dyslipidemia, probiotic bacteria

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lactobacillus plantarum PCS 26
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Only vehicle components in powdery form for 3 months Vehicle: 70 % glucose, 15 % powder milk, 15 % whey
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Lactobacillus plantarum PCS 26
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Taking dietary supplement on a daily basis for 3 months.
    Primary Outcome Measure Information:
    Title
    Serum lipids concentrations after daily consumption of dietary supplement in patients with the metabolic syndrome
    Description
    Serum total cholesterol, triglycerides, LDL and HDL concentrations
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Measures of body composition after daily consumption of dietary supplement in patients with the metabolic syndrome
    Description
    Body weight, body mass without body fat, total body fat, body volume, muscle mass, body mass index, visceral fat, subcutaneous fat, blood pressure
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pavel Skok, DSc, MD
    Organizational Affiliation
    University Medical Centre Maribor
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mario Gorenjak, DSc, MBioinf, BHSc
    Organizational Affiliation
    Faculty of Medicine, University of Maribor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Probiotic Bacteria in Prevention of the Metabolic Syndrome

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