Effect of Dietary Phospholipids on Atopic Dermatitis

Not Applicable

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Dietary Supplement: milk phospholipid; Dietary Supplement: diary product

• Registration Number: NCT01326520
• Lead Sponsor: University of Jena

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-31
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-19
• Last Update Posted: 2012-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phospholipid enriched dairy product	milk phospholipid	-
dairy product	diary product	-

Primary Outcome Measures

Name	Time	Method
Change in skin texture from baseline and in comparison with placebo	after 0,2,10,16, and 24 weeks	SCORAD Index

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Friedrich Schiller University Jena, Department of Nutritonional Physiology; 🇩🇪 Jena, Thuringia, Germany