Skip to main content
OpenTrials
Completed

NCT Number: NCT02288572

Probiotic Bacteria in Prevention of the Metabolic Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus plantarum PCS 26

Dietary Supplement

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.

Placebo

Dietary Supplement

Taking dietary supplement on a daily basis for 3 months.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Maribor

Other

Collaborators

  • Slovenian Research Agency

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 11, 2014
Registry last updated
Nov 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.