Probiotic Bacteria in Prevention of the Metabolic Syndrome
Condition: Metabolic Syndrome X
MeSH terms: Microvascular Angina; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): Lactobacillus plantarum PCS 26; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; Taking dietary supplement on a daily basis for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: metabolic syndrome X; obesity; insulin resistance; dyslipidemia; probiotic bacteria