Probiotic Bacteria in Prevention of the Metabolic Syndrome

Phase 2

Completed

• Conditions: Metabolic Syndrome X
• Interventions: Dietary Supplement: Lactobacillus plantarum PCS 26; Dietary Supplement: Placebo

• Registration Number: NCT02288572
• Lead Sponsor: University Maribor

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Status Verified: 2014-11
• Study First Submitted: 2014-11-02
• Study First Submitted QC: 2014-11-06
• Last Update Submitted: 2014-11-06
• Study First Posted: 2014-11-11
• Last Update Posted: 2014-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus plantarum PCS 26	Lactobacillus plantarum PCS 26	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
Placebo	Placebo	Only vehicle components in powdery form for 3 months Vehicle: 70 % glucose, 15 % powder milk, 15 % whey

Primary Outcome Measures

Name	Time	Method
Serum lipids concentrations after daily consumption of dietary supplement in patients with the metabolic syndrome	3 months	Serum total cholesterol, triglycerides, LDL and HDL concentrations

Secondary Outcome Measures

Name	Time	Method
Measures of body composition after daily consumption of dietary supplement in patients with the metabolic syndrome	3 months	Body weight, body mass without body fat, total body fat, body volume, muscle mass, body mass index, visceral fat, subcutaneous fat, blood pressure