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Effect of Dietary Phospholipids on Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT01326520
First received: March 28, 2011
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Dermatitis, Atopic
 Dietary Supplement: milk phospholipid
Dietary Supplement: diary product

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Dietary Milk Phospholipids on Subjects With Atopic Dermatitis

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • Change in skin texture from baseline and in comparison with placebo [ Time Frame: after 0,2,10,16, and 24 weeks ] [ Designated as safety issue: Yes ]
    SCORAD Index


Secondary Outcome Measures:
  • Immune status [ Time Frame: after 0,2,10,16, and 24 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Blood lipids (Total cholesterol, LDL cholesterol, HDL cholesterol, triacyl glycerdies, fatty acids, phospholipids)


Enrollment: 39
Study Start Date: March 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326520

Locations
Germany
Friedrich Schiller University Jena, Department of Nutritonional Physiology
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
Investigators
Principal Investigator: Gerhard Jahreis, Prof. Dr. Friedrich Schiller Univesity of Jena, Department of Nutritional Physiology
  More Information

No publications provided

Responsible Party: Gerhard Jahreis, Prof. Dr., University of Jena
ClinicalTrials.gov Identifier: NCT01326520     History of Changes
Other Study ID Numbers: LSEP H49-11
Study First Received: March 28, 2011
Last Updated: June 19, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
 Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013