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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02972567
• Date of registration: 17/11/2016
• Prospective Registration: No
• Primary sponsor: Biosearch S.A.
• Public title: Evaluation of the Effects of a L.Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease PROSIR
• Scientific 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
• Date of first enrolment: May 2016
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02972567
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Gil Ángel, Prof. Ph.D
• Affiliation: University of Granada (Spain)

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Metabolic Syndrome X

Intervention(s)

Dietary Supplement: Control

Dietary Supplement: Lactobacillus spp

Primary Outcome(s)

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

Secondary Outcome(s)

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]

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]

Secondary ID(s)

P3600

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Complejo Hospitalario de Jaen

Universidad de Granada