The Influence of Probiotics in a Drinkable Yogurt on Skin Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 1 The Influence of Probiotics in a Drinkable Yogurt on Skin Health

Conditions
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Skin Health

Intervention / Treatment
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* Dietary Supplement: no bacterial strains
* Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461
* Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus
* Dietary Supplement: Vit B2, B3, C and E, Beta Carotene and Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women as assessed by medical history and standard medical examination Caucasian Age: 25-55 y (inclusive) Normal BMI ≤ 30 Skin type 1-111 Regular Hormonal Cycle Having given his/her written informed consent Willing to avoid the consumption of fermented dairy products Minimum consumption of dark chocolate during the period of the study Exclusion Criteria: Smoker Pregnant or lactating women Post menopausal women Heavy alcohol intake (usually consuming more than 3 standard drinks/day) Intake of chronic medications except oral contraceptive Vitamin and/or mineral and/or antioxidant supplementation over the 3 months preceding the initiation of the study and throughout the study. Having skin cancer or genetic disposition to skin cancer Regular exposure to artificial UVR Daily exposure to sun more than one week over the 2 months preceding the initiation of the study Planned vacation to sun during the period of the study. Excessive tea drinkers (more than 2 cups a day of green or black tea). Excessive consumer of fermented dairy products (more than 150g per day). Excessive consumer of dark chocolate (> 25g per day). Regular high exercise such as a marathon Subject who regularly takes saunas (dry or wet) or swims daily. Subject who cannot be expected to comply with treatment Currently participating or having participated in another interventional clinical trial during the last 3 months prior to the beginning of this study.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Glucono-Delta-Lactone acidified milk containing no bacterial strains | Dietary Supplement: no bacterial strains<br>* Glucono-Delta-Lactone acidified milk containing no bacterial strains<br>|
| Experimental: 2<br>Glucono-Delta-Lactone acidified milk containing one probiotic strain called Lactobacillus paracasei NCC2461. | Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461<br>* Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain.<br>|
| Placebo Comparator: 3<br>Fermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii subsp.bulgaricus. | Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus<br>* Fermented milk containing two standard yogurt bacterial strains.<br>|
| Experimental: 4<br>Fermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii and one probiotic strain called Lactobacillus paracasei NCC2461. | Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461<br>* Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain.<br>Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus<br>* Fermented milk containing two standard yogurt bacterial strains.<br>|
| Experimental: 5<br>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. | Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461<br>* Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain.<br>Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus<br>* Fermented milk containing two standard yogurt bacterial strains.<br>Dietary Supplement: Vit B2, B3, C and E, Beta Carotene and Oil<br>* Fermented milk containing nutritional supplements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transepidermal water loss |  | baseline, 1 month, 2 months, 3 months, 5 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy markers: transglutaminase, filagrin, involucrin, loricrin (mRNA) |  | baseline and at 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin health, probiotics, dairy, oral