Lactobacillus Plantarum 3547 Effects Over Inflammatory and Immunologic Markers
NCT ID: NCT02622867
Last Updated: 2015-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
84 participants
INTERVENTIONAL
2013-02-28
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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.
Maltodextrin
1 daily capsule of maltodextrin (425 mg) during 12 weeks
Maltodextrin
During one period of parallel study (12 weeks), volunteers will consume 1 daily capsule of maltodextrin immediately after finishing their meal.
Interventions
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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.
Maltodextrin
During one period of parallel study (12 weeks), volunteers will consume 1 daily capsule of maltodextrin immediately after finishing their meal.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
45 Years
65 Years
ALL
Yes
Sponsors
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Creaciones Aromáticas Industriales S.A.
OTHER
Instituto de Investigación Hospital Universitario La Paz
OTHER
Responsible Party
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Principal Investigators
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Carmen Gómez Candela, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
La Paz University Hospital
Locations
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La Paz University Hospital
Madrid, Madrid, Spain
Countries
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Related Links
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La Paz University Hospital Research Institute
Other Identifiers
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Lactobacillus plantarum 3547
Identifier Type: -
Identifier Source: org_study_id