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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phospholipid enriched dairy product | Experimental |
| |
| dairy product | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| milk phospholipid | Dietary Supplement | The patients will consume daily 250 mL of a dairy product, which is enriched with 3 g of milk phospholipids. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Jahreis, Prof. Dr. | Friedrich Schiller Univesity of Jena, Department of Nutritional Physiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friedrich Schiller University Jena, Department of Nutritonional Physiology | Jena | Thuringia | 07743 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24559855 | Derived | Keller S, Le HY, Rodiger C, Hipler UC, Kertscher R, Malarski A, Hunstock LM, Kiehntopf M, Kaatz M, Norgauer J, Jahreis G. Supplementation of a dairy drink enriched with milk phospholipids in patients with atopic dermatitis - a double-blind, placebo-controlled, randomized, cross-over study. Clin Nutr. 2014 Dec;33(6):1010-6. doi: 10.1016/j.clnu.2014.01.014. Epub 2014 Jan 29. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| diary product | Dietary Supplement | The patients will consume daily 250 mL of a common dairy product. |
|
| after 0,2,10,16, and 24 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |