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Trial record 18 of 97 for:    Lactobacillus | maltodextrin

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
Sponsor:
Collaborators:
Universidad de Granada
Complejo Hospitalario de Jaen
Information provided by (Responsible Party):
Biosearch S.A.

Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Dietary Supplement: Lactobacillus spp Dietary Supplement: Control Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Probiotic
Lactobacillus strain
Dietary Supplement: Lactobacillus spp
9 log10 cfu/capsule. 1 capsule/day for 12 weeks

Placebo Comparator: Control
Maltodextrin
Dietary Supplement: Control
Maltodextrin




Primary Outcome Measures :
  1. Change from basal plasma lipopolysaccharide (LPS) at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]

Secondary Outcome Measures :
  1. Change from basal Blood pressure at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]
  2. Change from basal HOMA ( homeostatic model assessment ) index at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]
  3. Change from basal plasma cholesterol level (total, LDL and HDL) at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]
  4. 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 ]
  5. Change from basal Hepatic Steatosis markers (arginase, prolidase and RBP-4(Retinol binding protein-4)) at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]
  6. Changes from basal fecal microbiota at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Carolina Gómez, PhD 34958241000 gomezll@ugr.es
Contact: Mónica Olivares, Ph.D 34958240152 molivares@biosearchlife.es

Locations
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Spain
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      
Sponsors and Collaborators
Biosearch S.A.
Universidad de Granada
Complejo Hospitalario de Jaen
Investigators
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Study Director: Gil Ángel, Prof. Ph.D University of Granada (Spain)

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biosearch S.A.
ClinicalTrials.gov Identifier: NCT02972567     History of Changes
Other Study ID Numbers: P3600
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Biosearch S.A.:
probiotics
metabolic syndrome
non-alcoholic fatty liver disease
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Metabolic Syndrome
Inflammation
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases