Effect of Dietary Milk Phospholipids on Subjects With Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in skin texture from baseline and in comparison with placebo
研究概览
简要总结
The aim of the study is to investigate the influence of a milk phospholipid enriched dairy product on subjects with atopic dermatitis determining parameters of the immune status, the plasma lipid profile and the skin texture.
详细描述
Based on the facts, that on the one hand milk phospholipids are characterized by a high sphingolipid content and on the other hand a disturbed sphingolipid metabolism in the epidermis of patients with atopic dermatitis was verified, a double blinded, controlled, randomized, cross-over study with a daily supplementation of 3 g milk phospholipids to subjects with a mild to moderate atopic dermatitis will be conducted.
Forty patients will be randomized between two groups of each 20 patients. After an individual checkup and a run-in period of 2 weeks, the one group will receive the phospholipid enriched dairy product and the second group will be given a placebo dairy product over two month. A wash out-period of 4 weeks will follow, and the patients will consume the contrary dairy products over two month after a 2-week run-in period again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild to moderate atopic dermatitis (SCORAD < 30)
- •age: 18 - 60 years
排除标准
- •intolerance against milk proteins
- •systemic medication with corticosteroids or antihistamines
- •immune mediated disease
- •atherosclerosis
- •hyperlipidaemia
- •diabetes mellitus
- •angina pectoris
- •adipositas
- •pregnancy and breast feeding
结局指标
主要结局
Change in skin texture from baseline and in comparison with placebo
时间窗: after 0,2,10,16, and 24 weeks
SCORAD Index
次要结局
- Immune status(after 0,2,10,16, and 24 weeks)
- Lipid status(after 0,2,10,16, and 24 weeks)
研究者
Gerhard Jahreis
Prof. Dr.
University of Jena