Effect of Dietary Phospholipids on Atopic Dermatitis

June 19, 2012 updated by: Gerhard Jahreis, University of Jena

Effect of Dietary Milk Phospholipids on Subjects With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thuringia
      • Jena, Thuringia, Germany, 07743
        • Friedrich Schiller University Jena, Department of Nutritonional Physiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in skin texture from baseline and in comparison with placebo
Time Frame: after 0,2,10,16, and 24 weeks
SCORAD Index
after 0,2,10,16, and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 0,2,10,16, and 24 weeks
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)
after 0,2,10,16, and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Investigators

  • Principal Investigator: Gerhard Jahreis, Prof. Dr., Friedrich Schiller Univesity of Jena, Department of Nutritional Physiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

March 29, 2011

First Posted (Estimate)

March 31, 2011

Study Record Updates

Last Update Posted (Estimate)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSEP H49-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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