Skin Health
Conditions
Keywords
skin health, probiotics, dairy, oral
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTno bacterial strains
Glucono-Delta-Lactone acidified milk containing no bacterial strains
DIETARY_SUPPLEMENTOne probiotic strain - Lactobacillus paracasei NCC2461
Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain.
DIETARY_SUPPLEMENTTwo standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus
Fermented milk containing two standard yogurt bacterial strains.
DIETARY_SUPPLEMENTVit B2, B3, C and E, Beta Carotene and Oil
Fermented milk containing nutritional supplements
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transepidermal water loss | baseline, 1 month, 2 months, 3 months, 5 months and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Biopsy markers: transglutaminase, filagrin, involucrin, loricrin (mRNA) | baseline and at 5 months |
Countries
Germany
Outcome results
None listed