Effect of Dietary Phospholipids on Atopic Dermatitis
Effect of Dietary Milk Phospholipids on Subjects With Atopic Dermatitis
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJune 20, 2012
June 1, 2012
7 months
March 28, 2011
June 19, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change in skin texture from baseline and in comparison with placebo
SCORAD Index
after 0,2,10,16, and 24 weeks
Secondary Outcomes (2)
Immune status
after 0,2,10,16, and 24 weeks
Lipid status
after 0,2,10,16, and 24 weeks
Study Arms (2)
Phospholipid enriched dairy product
EXPERIMENTALdairy product
PLACEBO COMPARATORInterventions
The patients will consume daily 250 mL of a dairy product, which is enriched with 3 g of milk phospholipids.
The patients will consume daily 250 mL of a common dairy product.
Eligibility Criteria
You may qualify if:
- mild to moderate atopic dermatitis (SCORAD \< 30)
- age: 18 - 60 years
You may not qualify if:
- intolerance against milk proteins
- systemic medication with corticosteroids or antihistamines
- immune mediated disease
- atherosclerosis
- hyperlipidaemia
- diabetes mellitus
- angina pectoris
- adipositas
- pregnancy and breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Friedrich Schiller University Jena, Department of Nutritonional Physiology
Jena, Thuringia, 07743, Germany
Related Publications (1)
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.
PMID: 24559855DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard Jahreis, Prof. Dr.
Friedrich Schiller Univesity of Jena, Department of Nutritional Physiology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
March 28, 2011
First Posted
March 31, 2011
Study Start
March 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
June 20, 2012
Record last verified: 2012-06