Lactobacillus Plantarum 3547 Effects Over Inflammatory and Immunologic Markers

VOLUNTEERS Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622867
• Other study ID #: Lactobacillus plantarum 3547
• Status: Completed
• Phase: Phase 4
• First received: November 18, 2015
• Last updated: December 2, 2015
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2015
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

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, ?-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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• VOLUNTEERS

Intervention

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.

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

Locations

Country	Name	City	State
Spain	La Paz University Hospital	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Creaciones Aromáticas Industriales S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline interleukin 6 (IL-6)		0 and 12 weeks	Yes
Primary	Change from baseline interleukin 1ß (IL1ß)		0 and 12 weeks	Yes
Primary	Change from baseline interleukin 10 (IL10)		0 and 12 weeks	Yes
Primary	Change from baseline cytokine Tumor necrosis factor (TNFa)		0 and 12 weeks	Yes
Primary	Change from baseline Mcp1 (Monocyte Chemoattractant Protein-1)		0 and 12 weeks	Yes
Primary	Transforming growth factor beta 1 (TGF-ß1)		0 and 12 weeks	Yes
Primary	Change from baseline Interferon gamma (INF-?)		0 and 12 weeks	Yes
Secondary	Change from baseline cluster of differentiation 4 "CD4+T cells"		0 and 12 weeks	Yes
Secondary	Change from baseline T lymphocytes		0 and 12 weeks	Yes
Secondary	Change from baseline cluster of differentiation 8 "CD8+ T cells"		0 and 12 weeks	Yes
Secondary	Change from baseline natural killer cells		0 and 12 weeks	Yes
Secondary	Change from baseline B lymphocytes		0 and 12 weeks	Yes

External Links

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