Probiotic Bacteria in Prevention of the Metabolic Syndrome

Metabolic Syndrome X Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288572
• Other study ID #: MGPS001
• Status: Completed
• Phase: Phase 2
• First received: November 2, 2014
• Last updated: November 6, 2014
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: University Maribor
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Lactobacillus plantarum PCS 26
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
Taking dietary supplement on a daily basis for 3 months.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Maribor	Slovenian Research Agency

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum lipids concentrations after daily consumption of dietary supplement in patients with the metabolic syndrome	Serum total cholesterol, triglycerides, LDL and HDL concentrations	3 months	No
Secondary	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	3 months	No