Lactobacillus Plantarum 3547 Effects Over Inflammatory and Immunologic Markers

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

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.

Study Overview

• Status: Completed
• Conditions: VOLUNTEERS
• Intervention / Treatment: Other: Lactobacillus plantarum 3547; Dietary supplement: Maltodextrin

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)

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • La Paz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus plantarum 3547; 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; During one period of parallel study (12 weeks) volunteers consumed 1 capsule/daily with Lactobacillus plantarum 3547 immediately after finishing their meal.
Placebo Comparator: Maltodextrin; 1 daily capsule of maltodextrin (425 mg) during 12 weeks	Dietary supplement: Maltodextrin; During one period of parallel study (12 weeks), volunteers will consume 1 daily capsule of maltodextrin immediately after finishing their meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Creaciones Aromáticas Industriales S.A.

Publications and helpful links

Helpful Links

• Research group in Nutrition and Functional Foods (NUTRINVEST)
• La Paz University Hospital Research Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 7, 2015

Study Record Updates

• Last Update Posted (Estimate): December 7, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Probiotics; Randomized Controlled Trial; Lactobacillus plantarum; Maltodextrin
• Other Study ID Numbers: Lactobacillus plantarum 3547