Effect of Dietary Phospholipids on Atopic Dermatitis

NCT ID: NCT01326520

Last Updated: 2012-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Phospholipid enriched dairy product

Group Type EXPERIMENTAL

milk phospholipid

Intervention Type DIETARY_SUPPLEMENT

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

dairy product

Group Type PLACEBO_COMPARATOR

diary product

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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milk phospholipid

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

Intervention Type DIETARY_SUPPLEMENT

diary product

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jena

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Jahreis

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerhard Jahreis, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Friedrich Schiller Univesity of Jena, Department of Nutritional Physiology

Locations

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Friedrich Schiller University Jena, Department of Nutritonional Physiology

Jena, Thuringia, Germany

Site Status

Countries

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Germany

References

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Keller S, Le HY, Rodiger C, Hipler UC, Kertscher R, Malarski A, Hunstock LM, Kiehntopf M, Kaatz M, Norgauer J, Jahreis G. Supplementation of a dairy drink enriched with milk phospholipids in patients with atopic dermatitis - a double-blind, placebo-controlled, randomized, cross-over study. Clin Nutr. 2014 Dec;33(6):1010-6. doi: 10.1016/j.clnu.2014.01.014. Epub 2014 Jan 29.

Reference Type DERIVED
PMID: 24559855 (View on PubMed)

Other Identifiers

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LSEP H49-11

Identifier Type: -

Identifier Source: org_study_id

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