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NCT Number: NCT01326520

Effect of Dietary Phospholipids on Atopic Dermatitis

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.

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich Schiller University Jena, Department of Nutritonional Physiology

Jena, Thuringia, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Milk phospholipid

Dietary Supplement

The patients will consume daily 250 mL of a dairy product, which is enriched with 3 g of milk phospholipids.

diary product

Dietary Supplement

The patients will consume daily 250 mL of a common dairy product.

Primary outcomes

  1. Change in skin texture from baseline and in comparison with placebo

    Time frame: after 0,2,10,16, and 24 weeks

    SCORAD Index

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

Effect of Dietary Milk Phospholipids on Subjects With Atopic Dermatitis

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2011
Registry last updated
Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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