Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Creaciones Aromáticas Industriales S.A. | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Maltodextrin | Placebo Comparator | 1 daily capsule of maltodextrin (425 mg) during 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | 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" |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carmen Gómez Candela, MD, PhD | La Paz University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Paz University Hospital | Madrid | Madrid | 28046 | Spain |
Not provided
| Label | URL |
|---|---|
| La Paz University Hospital Research Institute | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| C008315 | maltodextrin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Maltodextrin | Dietary Supplement | During one period of parallel study (12 weeks), volunteers will consume 1 daily capsule of maltodextrin immediately after finishing their meal. |
|
| 0 and 12 weeks |
| Change from baseline natural killer cells | 0 and 12 weeks |
| Change from baseline B lymphocytes | 0 and 12 weeks |