Back to resultsEffect of Dietary Phospholipids on Atopic Dermatitis
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
milk phospholipid
diary product
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic
Eligibility Criteria
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
Sites / Locations
- Friedrich Schiller University Jena, Department of Nutritonional Physiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Phospholipid enriched dairy product
dairy product
Arm Description
Outcomes
Primary Outcome Measures
Change in skin texture from baseline and in comparison with placebo
SCORAD Index
Secondary Outcome Measures
Immune status
total IgE, specific IgE, sE selectin, Interferon-gamma, Tumor necrosis factor-alpha, Interleukin 4, 12, 16, 31
Lipid status
Blood lipids (Total cholesterol, LDL cholesterol, HDL cholesterol, triacyl glycerdies, fatty acids, phospholipids)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01326520
Brief Title
Effect of Dietary Phospholipids on Atopic Dermatitis
Official Title
Effect of Dietary Milk Phospholipids on Subjects With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phospholipid enriched dairy product
Arm Type
Experimental
Arm Title
dairy product
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
milk phospholipid
Intervention Description
The patients will consume daily 250 mL of a dairy product, which is enriched with 3 g of milk phospholipids.
Intervention Type
Dietary Supplement
Intervention Name(s)
diary product
Intervention Description
The patients will consume daily 250 mL of a common dairy product.
Primary Outcome Measure Information:
Title
Change in skin texture from baseline and in comparison with placebo
Description
SCORAD Index
Time Frame
after 0,2,10,16, and 24 weeks
Secondary Outcome Measure Information:
Title
Immune status
Description
total IgE, specific IgE, sE selectin, Interferon-gamma, Tumor necrosis factor-alpha, Interleukin 4, 12, 16, 31
Time Frame
after 0,2,10,16, and 24 weeks
Title
Lipid status
Description
Blood lipids (Total cholesterol, LDL cholesterol, HDL cholesterol, triacyl glycerdies, fatty acids, phospholipids)
Time Frame
after 0,2,10,16, and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Jahreis, Prof. Dr.
Organizational Affiliation
Friedrich Schiller Univesity of Jena, Department of Nutritional Physiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friedrich Schiller University Jena, Department of Nutritonional Physiology
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07743
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24559855
Citation
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.
Results Reference
derived
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Effect of Dietary Phospholipids on Atopic Dermatitis
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