Evaluation of the Effects of a L.Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease (PROSIR)

July 10, 2020 updated by: Biosearch S.A.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Jaen, Spain, 23007
        • Complejo Hospitalario Universitario de Jaen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a diagnosis of insulin resistance syndrome, according to Criteria of the International Diabetes Federation (IDF)
  • BMI>30 kg/m2 or Waist Circumference ≥ 94cm (men) WC≥ 80cm (women)
  • Serum Triglycerides ≥ 150 mg/dl
  • HDLcholesterol < 40 mg/dl (1,03 mmol/l) in men and < 50 mg/dl (1,29 mmol/l) in women
  • Systolic blood pressure ≥ 130 mmHg or diastolic ≥ 85 mmHg
  • Glucose ≥ 100 mg/dl (5,6 mmol/l) (not previous diagnostic of diabetes II)

Exclusion Criteria:

  • Patients with renal or hepatic impairment
  • Patients with a diagnosis of diabetes
  • Patients with diseases that condition immunosuppression
  • Patients presenting positive serologies for liver viruses
  • Being on antihypertensive treatment: beta-blockers, Angiotensin 2 receptor antagonists (ARA 2), enzyme inhibitors, Angiotensin converting enzyme (ACE) inhibitors.
  • Patients receiving lipid-lowering and / or hypoglycemic agents
  • Patients on treatment with drugs that increase hepatic enzymes,such as Amiodarone, perhexiline, maleate and 4,4'-diethylaminoethoxyhexestrol, synthetic estrogens, Tamoxifen, corticosteroids, acetylsalicylic acid, Valproic acid, tetracyclines, viral agents (zidovudine, zalcitabine, didanosine), among others.
  • Exhibiting high values of C-reactive protein (CRP) or Sedimentation (ESR)
  • Consuming alcohol in quantities greater than 40 g / d or other hepatotoxic.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Maltodextrin
Dietary supplement: Control
Maltodextrin
Experimental: Probiotic
Lactobacillus strain
Dietary supplement: Lactobacillus spp
9 log10 cfu/capsule. 1 capsule/day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from basal plasma lipopolysaccharide (LPS) at 12 weeks
Time Frame: Basal (T0), 12 weeks
Basal (T0), 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from basal Blood pressure at 12 weeks
Time Frame: Basal (T0), 12 weeks
Basal (T0), 12 weeks
Change from basal HOMA ( homeostatic model assessment ) index at 12 weeks
Time Frame: Basal (T0), 12 weeks
Basal (T0), 12 weeks
Change from basal plasma cholesterol level (total, LDL and HDL) at 12 weeks
Time Frame: Basal (T0), 12 weeks
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
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
Basal (T0), 12 weeks
Changes from basal fecal microbiota at 12 weeks
Time Frame: Basal (T0), 12 weeks
Basal (T0), 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosearch S.A.

Collaborators

Universidad de Granada
Complejo Hospitalario de Jaen

Investigators

  • Study Director: Gil Ángel, Prof. Ph.D, University of Granada (Spain)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (Estimate)

November 23, 2016

Study Record Updates

Last Update Posted (Actual)

July 13, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P3600

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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