Lactobacillus Plantarum 3547 Effects Over Inflammatory and Immunologic Markers

NCT02622867 | Completed Phase 4 DMC

• 1 other identifier: Lactobacillus plantarum 3547
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of the probiotic Lactobacillus plantarum 3547 over different inflammation and immune system markers on a healthy middle-aged group.

Conditions

VOLUNTEERS

Keywords

Lactobacillus plantarum; Maltodextrin; Probiotics; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (7)

• Change from baseline interleukin 6 (IL-6)

  0 and 12 weeks

• Change from baseline interleukin 1β (IL1β)

  0 and 12 weeks

• Change from baseline interleukin 10 (IL10)

  0 and 12 weeks

• Change from baseline cytokine Tumor necrosis factor (TNFα)

  0 and 12 weeks

• Change from baseline Mcp1 (Monocyte Chemoattractant Protein-1)

  0 and 12 weeks

• Transforming growth factor beta 1 (TGF-β1)

  0 and 12 weeks

• Change from baseline Interferon gamma (INF-γ)

  0 and 12 weeks

Secondary Outcomes (5)

• Change from baseline cluster of differentiation 4 "CD4+T cells"

  0 and 12 weeks

• Change from baseline T lymphocytes

  0 and 12 weeks

• Change from baseline cluster of differentiation 8 "CD8+ T cells"

  0 and 12 weeks

• Change from baseline natural killer cells

  0 and 12 weeks

• Change from baseline B lymphocytes

  0 and 12 weeks

Study Arms (2)

Lactobacillus plantarum 3547

EXPERIMENTAL

1 capsule/daily during 12 weeks with Lactobacillus plantarum 3547 (10x109 cfu/d). The capsule contains 77 mg probiotic Lp3547 and 390 mg maltodextrin

Other: Lactobacillus plantarum 3547

Maltodextrin

PLACEBO COMPARATOR

1 daily capsule of maltodextrin (425 mg) during 12 weeks

Dietary Supplement: Maltodextrin

Interventions

Lactobacillus plantarum 3547 OTHER

During one period of parallel study (12 weeks) volunteers consumed 1 capsule/daily with Lactobacillus plantarum 3547 immediately after finishing their meal.

Lactobacillus plantarum 3547

Maltodextrin DIETARY_SUPPLEMENT

During one period of parallel study (12 weeks), volunteers will consume 1 daily capsule of maltodextrin immediately after finishing their meal.

Maltodextrin

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women from 45 to 65 years old;
• Body Mass Index (BMI) ≥ 18,5 and \< 40 kg/m2
• Signed informed consent.
• Adequate cultural level and understanding for the clinical trial.
• Free of infections at baseline

You may not qualify if:

• Individuals with severe diseases (hepatic, kidney, cancer…);
• Individuals with diagnosed metabolic syndrome, diabetes and/or hyperthyroidism;
• Individuals with chronic intestinal pathologies (Gastritis, Colitis, Irritable Bowel Syndrome, Pseudomembranous Colitis, Crohn's disease…);
• Individuals with dementia, mental disease or low cognitive function;
• Individuals with autoimmune diseases and/or under treatment with corticosteroids and/or immunosuppressants;
• Individuals with major surgeries during the last month or gastrointestinal surgery in the last 3 months;
• Individuals treated with oral antibiotics during two weeks prior to the beginning of the study;
• Individuals undergoing dietary restriction and/or pharmacological treatment for the decrease of body weight 2 months prior to the beginning of the study;
• Individuals who intend to quit smoking during the next 20 weeks;
• Women that consume oral contraceptive;
• Pregnant women or breastfeeding;
• Individuals with intensive physical activity (\> 2 hours, more than 3 times per week);
• Individuals that consume antioxidant supplement, drugs, ω-3 supplements, vitamins, minerals, prebiotics or/and probiotics during the 2 weeks prior to the beginning of the study and that will not eliminate their consumption during the study;
• Individuals with regular consumption (\> 3 servings per week) of fermented foods (yogurt, actimel, kefir, blue cheese…) and/or use of other prebiotics and not to accept suppress their consumption during the study;
• Individuals with increased alcohol consumption \>30g/day (equivalent to 300 ml of wine, about 3 beers or a cup (75 ml) of whiskey , brandy , anise, etc);

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Creaciones Aromáticas Industriales S.A.: collaborator

Study Sites (1)

La Paz University Hospital

Madrid, Madrid, 28046, Spain

Location

Related Links

• La Paz University Hospital Research Institute

MeSH Terms

Interventions

maltodextrin

Study Officials

• Carmen Gómez Candela, MD, PhD

  La Paz University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: December 7, 2015
• Study Start: February 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

ES (1)