Effect of Dietary Phospholipids on Atopic Dermatitis

Study Overview
=================
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.

Official Title
-----------------
Effect of Dietary Milk Phospholipids on Subjects With Atopic Dermatitis

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Dietary Supplement: milk phospholipid
* Dietary Supplement: diary product


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phospholipid enriched dairy product<br> | Dietary Supplement: milk phospholipid<br>* The patients will consume daily 250 mL of a dairy product, which is enriched with 3 g of milk phospholipids.<br>|
| Placebo Comparator: dairy product<br> | Dietary Supplement: diary product<br>* The patients will consume daily 250 mL of a common dairy product.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skin texture from baseline and in comparison with placebo | SCORAD Index | after 0,2,10,16, and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune status | total IgE, specific IgE, sE selectin, Interferon-gamma, Tumor necrosis factor-alpha, Interleukin 4, 12, 16, 31 | after 0,2,10,16, and 24 weeks | 
| Lipid status | Blood lipids (Total cholesterol, LDL cholesterol, HDL cholesterol, triacyl glycerdies, fatty acids, phospholipids) | after 0,2,10,16, and 24 weeks |