Effect of Dietary Phospholipids on Atopic Dermatitis
|ClinicalTrials.gov Identifier: NCT01326520|
Recruitment Status : Completed
First Posted : March 31, 2011
Last Update Posted : June 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Dermatitis, Atopic||Dietary Supplement: milk phospholipid Dietary Supplement: diary product||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Dietary Milk Phospholipids on Subjects With Atopic Dermatitis|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
|Experimental: Phospholipid enriched dairy product||
Dietary Supplement: milk phospholipid
The patients will consume daily 250 mL of a dairy product, which is enriched with 3 g of milk phospholipids.
|Placebo Comparator: dairy product||
Dietary Supplement: diary product
The patients will consume daily 250 mL of a common dairy product.
- Change in skin texture from baseline and in comparison with placebo [ Time Frame: after 0,2,10,16, and 24 weeks ]SCORAD Index
- Immune status [ Time Frame: 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 [ Time Frame: after 0,2,10,16, and 24 weeks ]Blood lipids (Total cholesterol, LDL cholesterol, HDL cholesterol, triacyl glycerdies, fatty acids, phospholipids)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326520
|Friedrich Schiller University Jena, Department of Nutritonional Physiology|
|Jena, Thuringia, Germany, 07743|
|Principal Investigator:||Gerhard Jahreis, Prof. Dr.||Friedrich Schiller Univesity of Jena, Department of Nutritional Physiology|