Evaluation of the Effects of a L.Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease
Condition: Metabolic Syndrome X
MeSH terms: Liver Diseases; Fatty Liver; Metabolic Syndrome; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is the evaluation of the effects in obese patients with metabolic
      syndrome on the composition of the intestinal microbiota, markers of the syndrome
      (hypertension, dyslipidemia, inflammation biomarkers, risk cardiovascular and hepatic
      steatosis) and other possible metabolites involved.
    

Detailed description: 
      Randomized double blind crossover placebo controlled intervention study

      The proposed study will be conducted by members of the Endocrinology and Nutrition Services
      (ENCHJ), and Gastroenterology (ADCHJ), of the Hospital of Jaen and members of the Department
      of Biochemistry and Molecular Biology II of the University of Granada (UGR) and members of
      Microbiology Department of the University Hospital San Cecilio of Granada (MHUSC).

      The selection, clinical and anthropometric control, general biochemical parameters and the
      determination of hepatic steatosis by ultrasound will be performed by members of ENCHJ.

      The determination of the composition of the intestinal microbiota will be carried out by
      members of the UGR together with members form the MHUSC. Inflammation and steatosis
      biomarkers as well as metabolic profile will be performed by members of the UGR.

      The study will be conducted according to the Helsinki Rules and will be previously approved
      by the Ethics Committee of Research of Jaen. The study will follow the rules of
      international, national and regional research The biological samples will be managed and
      processed in accordance with the research protocols by the Biobanco del Sistema Sanitario
      Público de Andalucía. At the end of the project, samples will be stored within the framework
      of Biobank from Public Health Organization of Andalusia .

      The present study involves access and use of information confidential, so all the data will
      be treated anonymously.

      • Sample size assessment to specify the number of participants or participant years necessary
      to demonstrate an effect.

      Based on the range and median value on plasma lipopolysaccharide (LPS), and assuming a power
      of 90% and a type error alpha of 5%, the minimum number of subjects was 32. To avoid possible
      bias caused by gender and taking into account the withdrawal, will be recruited 60 subjects.

      The missing data will be considered as unavailable data.

      All statistical analyses will be performed using the statistical package SPSS (Statistical
      Product and Service Solutions). Normally distributed data will be expressed as the mean and
      standard error of the mean, whereas median and ranges will be used for data not normally
      distributed.
    

Intervention name(s): Lactobacillus spp; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 9 log10 cfu/capsule. 1 capsule/day for 12 weeks; Maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: probiotics; metabolic syndrome; non-alcoholic fatty liver disease