Dermatitis, Atopic
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTmilk phospholipid
The patients will consume daily 250 mL of a dairy product, which is enriched with 3 g of milk phospholipids.
DIETARY_SUPPLEMENTdiary product
The patients will consume daily 250 mL of a common dairy product.
Sponsors
University of Jena
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* mild to moderate atopic dermatitis (SCORAD \< 30) * age: 18 - 60 years
Exclusion criteria
* intolerance against milk proteins * systemic medication with corticosteroids or antihistamines * immune mediated disease * atherosclerosis * hyperlipidaemia * diabetes mellitus * angina pectoris * adipositas * pregnancy and breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin texture from baseline and in comparison with placebo | after 0,2,10,16, and 24 weeks | SCORAD Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune status | after 0,2,10,16, and 24 weeks | total IgE, specific IgE, sE selectin, Interferon-gamma, Tumor necrosis factor-alpha, Interleukin 4, 12, 16, 31 |
| Lipid status | after 0,2,10,16, and 24 weeks | Blood lipids (Total cholesterol, LDL cholesterol, HDL cholesterol, triacyl glycerdies, fatty acids, phospholipids) |
Countries
Germany
Outcome results
None listed