Skin Health Clinical Trial
Official title:
Phase 1 The Influence of Probiotics in a Drinkable Yogurt on Skin Health
Verified date | September 2009 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
The aim of this study is to test if probiotics administered to healthy female subjects in a dairy format have any skin health benefits.
Status | Completed |
Enrollment | 207 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 55 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Germany | Institut für umweltmedizinische Forschung (IUF) an der Heinrich-Heine-Universität Düsseldorf gGmbH | Düsseldorf |
Lead Sponsor | Collaborator |
---|---|
Nestlé |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transepidermal water loss | baseline, 1 month, 2 months, 3 months, 5 months and 6 months | No | |
Secondary | Biopsy markers: transglutaminase, filagrin, involucrin, loricrin (mRNA) | baseline and at 5 months | No |
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