Clinical trial NCT02622867: Lactobacillus Plantarum 3547 Effects Over Inflammatory and Immunologic Markers
Official title: Nutritional Intervention Clinical Trial to Evaluate the Lactobacillus Plantarum 3547 Probiotic Effects Over Different Inflammation and Immune System Markers in a Group of Healthy Middle-aged People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: VOLUNTEERS
Keywords: Lactobacillus plantarum
Maltodextrin
Probiotics
Randomized Controlled Trial
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Creaciones Aromáticas Industriales S.A.
First posted: 2015-12-07
Enrollment: 84
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: In this randomized double blind controlled trial, a group of healthy middle-aged people (45 to 65 years old) had a nutritional intervention to evaluate the Lactobacillus plantarum 3547 probiotic effects over different inflammation and immune system markers, the experimental group took the experimental supplement (Lactobacillus plantarum 3547) during one period of parallel study (12 weeks), the volunteers consumed 1 capsule/daily with Lactobacillus plantarum 3547 (10x109 cfu/d) immediately after finishing their meal, the capsule contains: 77 mg probiotic Lp3547 and 390 mg maltodextrins. The control group took the control supplement (Maltodextrin) during one period of parallel study (12 weeks), volunteers consumed 1 daily capsule of maltodextrin without Lactobacillus plantarum 3547 (Placebo) immediately after finishing their meal. (The capsule contains 425 mg of maltodextrin)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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);
* Individuals with regular use of laxatives (\> 2 a week) and (Laxbene, Miralax, Dulco - Lax, etc.) and does not accept suppress its consumption during the study period.

Primary outcomes:
measure: Change from baseline interleukin 6 (IL-6)
timeFrame: 0 and 12 weeks
measure: Change from baseline interleukin 1β (IL1β)
timeFrame: 0 and 12 weeks
measure: Change from baseline interleukin 10 (IL10)
timeFrame: 0 and 12 weeks
measure: Change from baseline cytokine Tumor necrosis factor (TNFα)
timeFrame: 0 and 12 weeks
measure: Change from baseline Mcp1 (Monocyte Chemoattractant Protein-1)
timeFrame: 0 and 12 weeks
measure: Transforming growth factor beta 1 (TGF-β1)
timeFrame: 0 and 12 weeks
measure: Change from baseline Interferon gamma (INF-γ)
timeFrame: 0 and 12 weeks
Secondary outcomes:
measure: Change from baseline cluster of differentiation 4 "CD4+T cells"
timeFrame: 0 and 12 weeks
measure: Change from baseline T lymphocytes
timeFrame: 0 and 12 weeks
measure: Change from baseline cluster of differentiation 8 "CD8+ T cells"
timeFrame: 0 and 12 weeks
measure: Change from baseline natural killer cells
timeFrame: 0 and 12 weeks
measure: Change from baseline B lymphocytes
timeFrame: 0 and 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
affiliation: La Paz University Hospital
name: Carmen Gómez Candela, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: