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The aim of this study is to test if probiotics administered to healthy female subjects in a dairy format have any skin health benefits.
This is a placebo-controlled, double blind, randomized, single center, human clinical trial aimed at assessing the influence of probiotics on skin health in healthy female subjects, when administered in a food matrix over a period of 5 months.
It will consist of five groups(40 subjects/group). The first group (1) of subjects will receive acidified milk that does not contain bacterial strains. The second group (2) will receive acidified milk that contains one specific probiotic strain. The third group (3) will receive fermented milk that contains a standard mix of yogurt bacterial strains. The fourth group (4) will receive fermented milk, containing the same standard mix of yogurt bacterial strains as in group 3 plus the same specific probiotic strain as in group 2. Finally, the fifth group (5) will receive fermented milk, containing the same standard mix of yogurt bacterial strains as in group 3 and 4 plus the same specific probiotic strain as in group 2 and 4 plus a mix of antioxidants.
This study will address whether:
A.The bioefficacy of a specific probiotic strain is influenced by a milk matrix.
B.Whether other bacterial strains impact the bioefficacy of this specific probiotic strain, and validate whether or not the bioefficacy is related entirely to the activity of this specific probiotic strain.
C.Whether nutritional supplements impact the bioefficacy of a specific probiotic strain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Glucono-Delta-Lactone acidified milk containing no bacterial strains |
|
| 2 | Experimental | Glucono-Delta-Lactone acidified milk containing one probiotic strain called Lactobacillus paracasei NCC2461. |
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| 3 | Placebo Comparator | Fermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii subsp.bulgaricus. |
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| 4 | Experimental | Fermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii and one probiotic strain called Lactobacillus paracasei NCC2461. |
|
| 5 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no bacterial strains | Dietary Supplement | Glucono-Delta-Lactone acidified milk containing no bacterial strains |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal water loss | baseline, 1 month, 2 months, 3 months, 5 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy markers: transglutaminase, filagrin, involucrin, loricrin (mRNA) | baseline and at 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für umweltmedizinische Forschung (IUF) an der Heinrich-Heine-Universität Düsseldorf gGmbH | Düsseldorf | 40225 | Germany |
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Fermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii, one probiotic strain called Lactobacillus paracasei NCC2461 and Vitamin B2,B3, C and E, Beta Carotene and an Oil.
|
| One probiotic strain - Lactobacillus paracasei NCC2461 | Dietary Supplement | Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain. |
|
| Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus | Dietary Supplement | Fermented milk containing two standard yogurt bacterial strains. |
|
| Vit B2, B3, C and E, Beta Carotene and Oil | Dietary Supplement | Fermented milk containing nutritional supplements |
|
| ID | Term |
|---|---|
| C053396 | L 644711 |
| D019207 | beta Carotene |
| D009821 | Oils |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D008055 | Lipids |
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