Metabolic Syndrome X Clinical Trial
Official title:
Evaluation of the Effect of a Lactobacillus Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease in Obese Subjects With Insulin Resistance
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.
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.
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