Evaluation of the Effects of a L.Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease (PROSIR)
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|ClinicalTrials.gov Identifier: NCT02972567|
Recruitment Status : Unknown
Verified November 2016 by Biosearch S.A..
Recruitment status was: Recruiting
First Posted : November 23, 2016
Last Update Posted : November 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome X||Dietary Supplement: Lactobacillus spp Dietary Supplement: Control||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||June 2017|
Dietary Supplement: Lactobacillus spp
9 log10 cfu/capsule. 1 capsule/day for 12 weeks
Placebo Comparator: Control
Dietary Supplement: Control
- Change from basal plasma lipopolysaccharide (LPS) at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]
- Change from basal Blood pressure at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]
- Change from basal HOMA ( homeostatic model assessment ) index at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]
- Change from basal plasma cholesterol level (total, LDL and HDL) at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]
- Change from basal plasma Inflammatory markers (sVCAM, sICAM, myeloperoxidase selectin, adiponectin, plasminogen activator inhibitor and resistin, and interleukines Il-6, Il-8, tumor necrosis factor, HGF, leptin and Multicopper oxidase-1) at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]
- Change from basal Hepatic Steatosis markers (arginase, prolidase and RBP-4(Retinol binding protein-4)) at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]
- Changes from basal fecal microbiota at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972567
|Contact: Carolina Gómez, PhDfirstname.lastname@example.org|
|Contact: Mónica Olivares, Ph.Demail@example.com|
|Complejo Hospitalario Universitario de Jaen||Recruiting|
|Jaen, Spain, 23007|
|Contact: Maria-José Martínez-Ramírez, MD 34 953 00 80 00|
|Contact: Carmen Tenorio, MD 34 953 00 80 00|
|Study Director:||Gil Ángel, Prof. Ph.D||University of Granada (Spain)|