Dermatitis, AtopicNCT01326520
Effect of Dietary Phospholipids on Atopic Dermatitis
A study testing milk phospholipid and diary product in people with Dermatitis, Atopic, run by University of Jena at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- milk phospholipid and diary product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- mild to moderate atopic dermatitis (SCORAD < 30)
- age: 18 - 60 years
Who cannot join
- intolerance against milk proteins
- systemic medication with corticosteroids or antihistamines
- immune mediated disease
- atherosclerosis
- hyperlipidaemia
- diabetes mellitus
Show all 9Show fewer
- angina pectoris
- adipositas
- pregnancy and breast feeding
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich Schiller University Jena, Department of Nutritonional Physiology
Jena, Thuringia, 07743
About this study
Official title: Effect of Dietary Milk Phospholipids on Subjects With Atopic Dermatitis
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.
Read the 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.
- Conditions
- Dermatitis, Atopic
- Being tested
- milk phospholipid, diary product
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milk phospholipidDietary supplement
The patients will consume daily 250 mL of a dairy product, which is enriched with 3 g of milk phospholipids.
diary productDietary supplement
The patients will consume daily 250 mL of a common dairy product.
| Study group | Role | What they receive |
|---|---|---|
| Phospholipid enriched dairy product | Experimental | Not described Receives: Dietary Supplement: milk phospholipid |
| dairy product | Placebo comparator | Not described Receives: Dietary Supplement: diary product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin texture from baseline and in comparison with placebo
SCORAD Index
Measured: after 0,2,10,16, and 24 weeks
Secondary outcomes (2)
Immune status
total IgE, specific IgE, sE selectin, Interferon-gamma, Tumor necrosis factor-alpha, Interleukin 4, 12, 16, 31
Measured: after 0,2,10,16, and 24 weeks
Lipid status
Blood lipids (Total cholesterol, LDL cholesterol, HDL cholesterol, triacyl glycerdies, fatty acids, phospholipids)
Measured: after 0,2,10,16, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Jahreis, University of Jena
- Investigators
- Gerhard Jahreis, Prof. Dr., Principal investigator, Friedrich Schiller Univesity of Jena, Department of Nutritional Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326520
- Sponsor's protocol ID
- LSEP H49-11
- Status last verified
- Jun 2012
- First submitted
- 28 Mar 2011
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24559855
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Milk Phospholipids on Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01326520
- Acronym / sponsor ID
- LSEP H49-11
- Conditions
- Dermatitis, Atopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 31 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phospholipid enriched dairy product | Experimental | Dietary Supplement: milk phospholipid |
| dairy product | Placebo comparator | Dietary Supplement: diary product |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- mild to moderate atopic dermatitis (SCORAD < 30)
- age: 18 - 60 years
Key exclusion criteria (9 listed)
- intolerance against milk proteins
- systemic medication with corticosteroids or antihistamines
- immune mediated disease
- atherosclerosis
- hyperlipidaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| milk phospholipidThe patients will consume daily 250 mL of a dairy product, which is enriched with 3 g of milk phospholipids. | Dietary supplement | Phospholipid enriched dairy product |
| diary productThe patients will consume daily 250 mL of a common dairy product. | Dietary supplement | dairy product |
Primary outcome
Change in skin texture from baseline and in comparison with placebo
Time frame: after 0,2,10,16, and 24 weeks
SCORAD Index
2 secondary outcomes
Immune status
Time frame: after 0,2,10,16, and 24 weeks
Lipid status
Time frame: after 0,2,10,16, and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Derived from this study: PubMed 24559855Keller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Jahreis, Prof. Dr. principal investigator
Friedrich Schiller Univesity of Jena, Department of Nutritional Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing milk phospholipid and diary product in people with Dermatitis, Atopic, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin texture from baseline and in comparison with placebo (time frame: after 0,2,10,16, and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01326520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.