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

Tracking Information

First Received Date ^ICMJE

March 28, 2011

Last Updated Date

June 19, 2012

Start Date ^ICMJE

March 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01326520 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Dietary Phospholipids on Atopic Dermatitis

Official Title ^ICMJE

Effect of Dietary Milk Phospholipids on Subjects With Atopic Dermatitis

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Dermatitis, Atopic

Intervention ^ICMJE

Dietary Supplement: milk phospholipid
The patients will consume daily 250 mL of a dairy product, which is enriched with 3 g of milk phospholipids.
Dietary Supplement: diary product
The patients will consume daily 250 mL of a common dairy product.

Study Arm (s)

Experimental: Phospholipid enriched dairy product
Intervention: Dietary Supplement: milk phospholipid
Placebo Comparator: dairy product
Intervention: Dietary Supplement: diary product

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01326520

Other Study ID Numbers ^ICMJE

LSEP H49-11

Has Data Monitoring Committee

Yes

Responsible Party

Gerhard Jahreis, University of Jena

Study Sponsor ^ICMJE

University of Jena

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gerhard Jahreis, Prof. Dr.

Friedrich Schiller Univesity of Jena, Department of Nutritional Physiology

Information Provided By

University of Jena

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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