Phase 1 The Influence of Probiotics in a Drinkable Yogurt on Skin Health
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 2
- 主要终点
- Transepidermal water loss
研究概览
简要总结
The aim of this study is to test if probiotics administered to healthy female subjects in a dairy format have any skin health benefits.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Transepidermal water loss
时间窗: baseline, 1 month, 2 months, 3 months, 5 months and 6 months
次要结局
- Biopsy markers: transglutaminase, filagrin, involucrin, loricrin (mRNA)(baseline and at 5 months)