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
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
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
NCT ID
NCT02288572
First Posted
November 2, 2014
Last Updated
November 6, 2014
Sponsor
University Maribor
Collaborators
Slovenian Research Agency
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
Learn more about this trial
Probiotic Bacteria in Prevention of the Metabolic Syndrome
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