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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014