Atopic Dermatitis
Conditions
Keywords
Cetoleic acid, LC-MUFA, Ezcema, Nutritional study
Brief summary
Atopic Dermatitis is associated with pronounced changes in the lipid composition in the skin. The lipid changes are influenced by and contributing to both the inflammatory circuit and the impaired barrier as well as changes in the skin microbiome This nutritional study will investigate the effect of long-chain monounsaturated fatty acid Cetoleic acid on atoptic dermatitis. Earlier studies have shown a anti-inflammatory effect of celoteic acid.
Detailed description
Women and men will be recruited to a placebo or a cetoleic-rich fish oil group and be examined for the effect on atopic dermatitis before, during and after the study period.
Interventions
DIETARY_SUPPLEMENTLC-MUFA oil
2 x 1 g capsules containing marine oil from North Atlantic fish
DIETARY_SUPPLEMENTPlacebo
2 x 1 g capsules containing corn oil
Sponsors
Helse Møre og Romsdal HF
Epax Norway AS
University of Manchester
Møreforsking AS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Interventions are given as 1g bovine capsules of equal size, weight and appearance, and provided in identical bottles with a coded label.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Women and men 18-80 years of age. * Diagnosed with active mild to moderate atopic dermatitis with an EASI of 1.1- 21.0. * Willing to refrain from oil supplements (omega-3, borage, evening primrose, etc.) for 1 month before study begin (washout) and during the study * Willing to take the study supplement for 6 months
Exclusion criteria
* Known allergy to fish products * Subjects known to be pregnant or breast feeding * Subjects perceiving systemically administered medication for AD (other than topical) * Subjects with auto-immune diseases (except asthma and seasonal/perennial rhinitis) * Subjects with a diagnosis of other skin diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EASI | 6 months | Change in EASI (Eczema Area and Serverity Index) POEM). |
| DQLI | 6 months | Change in DQLI |
| POEM | 6 months | Change in POEM (Patient Oriented Eczema Measure) |
| Itch Numerical Rating Scale (NRS) | 6 months | Change in experienced itch on average the last 24 hours, and how the worst itch in the past 24 hours was. Scale from 0 (no itch) to 10 (worst imaginable itch). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TEWL | 6 months | The change in trans-epidermal water loss (TEWL) |
| Hydroxylated omega-3 fatty acids in plasma | 6 months | The change of hydroxylated omega-3 fatty acids in plasma |
| Fatty acid composition in red blood cells | 6 months | Determine the change in fatty acid composition in red blood cells |
| Cetoleic acid with EASI parameters | 6 months | The association of cetoleic acid content in RBCs with EASI parameters |
| Omega-3 index with EASI parameters | 6 months | The association of omega-3 index with EASI parameters |
| Lipid compositions in skin | 6 months | The change of ceramide/lipid composition in skin |
| Inflammation in skin | 6 months | The change in inflammatory signalling molecules in skin |
| Blood lipids | 6 months | The change in cholesterol/blood lipid profile |
Countries
Norway
Contacts
Primary ContactLisa Kolden Midtbø, PhD
Backup ContactJennifer Mildenberger, PhD
Outcome results
None listed