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Effect of Dietary Phospholipids on Atopic Dermatitis

U

University of Jena

Status

Completed

Conditions

Dermatitis, Atopic

Treatments

Dietary Supplement: milk phospholipid
Dietary Supplement: diary product

Study type

Interventional

Funder types

Other

Identifiers

NCT01326520
LSEP H49-11

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

39 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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