A Randomized, Double-blinded Nutritional Study to Determine the Effect of a Concentrated Cetoleic Acid Fish Oil on Atopic Dermatitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis
- Sponsor
- Møreforsking AS
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- POEM
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
- •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
Outcomes
Primary Outcomes
POEM
Time Frame: 6 months
Change in POEM (Patient Oriented Eczema Measure)
EASI
Time Frame: 6 months
Change in EASI (Eczema Area and Serverity Index) POEM).
DQLI
Time Frame: 6 months
Change in DQLI
Itch Numerical Rating Scale (NRS)
Time Frame: 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 Outcomes
- Lipid compositions in skin(6 months)
- Inflammation in skin(6 months)
- TEWL(6 months)
- Blood lipids(6 months)
- Cetoleic acid with EASI parameters(6 months)
- Omega-3 index with EASI parameters(6 months)
- Fatty acid composition in red blood cells(6 months)
- Hydroxylated omega-3 fatty acids in plasma(6 months)