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Trial record 18 of 103 for:    Lactobacillus | maltodextrin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE November 17, 2016
First Posted Date  ICMJE November 23, 2016
Last Update Posted Date November 23, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2016)
Change from basal plasma lipopolysaccharide (LPS) at 12 weeks [ Time Frame: Basal (T0), 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effects of a L.Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome X
Intervention  ICMJE
  • Dietary Supplement: Lactobacillus spp
    9 log10 cfu/capsule. 1 capsule/day for 12 weeks
  • Dietary Supplement: Control
    Maltodextrin
Study Arms  ICMJE
  • Experimental: Probiotic
    Lactobacillus strain
    Intervention: Dietary Supplement: Lactobacillus spp
  • Placebo Comparator: Control
    Maltodextrin
    Intervention: Dietary Supplement: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 21, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02972567
Other Study ID Numbers  ICMJE P3600
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Biosearch S.A.
Study Sponsor  ICMJE Biosearch S.A.
Collaborators  ICMJE
  • Universidad de Granada
  • Complejo Hospitalario de Jaen
Investigators  ICMJE
Study Director: Gil Ángel, Prof. Ph.D University of Granada (Spain)
PRS Account Biosearch S.A.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP