Effect of Dietary Phospholipids on Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

Official title:

Effect of Dietary Milk Phospholipids on Subjects With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326520
• Other study ID #: LSEP H49-11
• Status: Completed
• Phase: N/A
• First received: March 28, 2011
• Last updated: June 19, 2012
• Start date: March 2011
• Est. completion date: October 2011

Study information

• Verified date: June 2012
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
Germany	Friedrich Schiller University Jena, Department of Nutritonional Physiology	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in skin texture from baseline and in comparison with placebo	SCORAD Index	after 0,2,10,16, and 24 weeks	Yes
Secondary	Immune status	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	Yes
Secondary	Lipid status	Blood lipids (Total cholesterol, LDL cholesterol, HDL cholesterol, triacyl glycerdies, fatty acids, phospholipids)	after 0,2,10,16, and 24 weeks	Yes