Clinical Trial: Probiotic Bacteria in Prevention of the Metabolic Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Mechanisms of Action of Probiotic and Protective Bacteria PCS 20, PCS 26, and LGG in Prevention of the Metabolic Syndrome

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

Detailed Summary:
Sponsor: University Maribor

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Measures of body composition after daily consumption of dietary supplement in patients with the metabolic syndrome [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: University Maribor

Dates:
Date Received: November 2, 2014
Date Started: May 2013
Date Completion:
Last Updated: November 6, 2014
Last Verified: November 2014