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

NCT02972567 | Completed

• 1 other identifier: P3600
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome X

Keywords

probiotics; metabolic syndrome; non-alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (1)

• Change from basal plasma lipopolysaccharide (LPS) at 12 weeks

  Basal (T0), 12 weeks

Secondary Outcomes (6)

• Change from basal Blood pressure at 12 weeks

  Basal (T0), 12 weeks

• Change from basal HOMA ( homeostatic model assessment ) index at 12 weeks

  Basal (T0), 12 weeks

• Change from basal plasma cholesterol level (total, LDL and HDL) at 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

  Basal (T0), 12 weeks

• Change from basal Hepatic Steatosis markers (arginase, prolidase and RBP-4(Retinol binding protein-4)) at 12 weeks

  Basal (T0), 12 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Lactobacillus strain

Dietary Supplement: Lactobacillus spp

Control

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Control

Interventions

Lactobacillus spp DIETARY_SUPPLEMENT

9 log10 cfu/capsule. 1 capsule/day for 12 weeks

Probiotic

Control DIETARY_SUPPLEMENT

Maltodextrin

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosearch S.A.: lead
• Universidad de Granada: collaborator
• Complejo Hospitalario de Jaen: collaborator

Study Sites (1)

Complejo Hospitalario Universitario de Jaen

Jaén, 23007, Spain

Location

Related Publications (4)

• Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006 Dec 21;444(7122):1027-31. doi: 10.1038/nature05414.

  PMID: 17183312 RESULT

• Backhed F, Manchester JK, Semenkovich CF, Gordon JI. Mechanisms underlying the resistance to diet-induced obesity in germ-free mice. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):979-84. doi: 10.1073/pnas.0605374104. Epub 2007 Jan 8.

  PMID: 17210919 RESULT

• Bermudez-Brito M, Munoz-Quezada S, Gomez-Llorente C, Matencio E, Bernal MJ, Romero F, Gil A. Human intestinal dendritic cells decrease cytokine release against Salmonella infection in the presence of Lactobacillus paracasei upon TLR activation. PLoS One. 2012;7(8):e43197. doi: 10.1371/journal.pone.0043197. Epub 2012 Aug 14.

  PMID: 22905233 RESULT

• Tenorio-Jimenez C, Martinez-Ramirez MJ, Tercero-Lozano M, Arraiza-Irigoyen C, Del Castillo-Codes I, Olza J, Plaza-Diaz J, Fontana L, Migueles JH, Olivares M, Gil A, Gomez-Llorente C. Evaluation of the effect of Lactobacillus reuteri V3401 on biomarkers of inflammation, cardiovascular risk and liver steatosis in obese adults with metabolic syndrome: a randomized clinical trial (PROSIR). BMC Complement Altern Med. 2018 Nov 20;18(1):306. doi: 10.1186/s12906-018-2371-x.

  PMID: 30453950 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Gil Ángel, Prof. Ph.D

  University of Granada (Spain)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 23, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)