Nutritional Study to Determine the Effect of Fish Oil on Atopic Dermatitis

Not Applicable

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Dietary Supplement: LC-MUFA oil; Dietary Supplement: Placebo

• Registration Number: NCT06194045
• Lead Sponsor: Møreforsking AS

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.

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-01
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2024-01-08
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LC-MUFA oil	LC-MUFA oil	2x1g capsules containing concentrated marine oil from north atlantic fish
Placebo	Placebo	2x1g capsules containing corn oil

Primary Outcome Measures

Name	Time	Method
DQLI	6 months	Change in DQLI
POEM	6 months	Change in POEM (Patient Oriented Eczema Measure)
EASI	6 months	Change in EASI (Eczema Area and Serverity Index) POEM).
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 Outcome Measures

Name	Time	Method
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
TEWL	6 months	The change in trans-epidermal water loss (TEWL)
Blood lipids	6 months	The change in cholesterol/blood lipid profile
Cetoleic acid with EASI parameters	6 months	The association of cetoleic acid content in RBCs with EASI parameters
Fatty acid composition in red blood cells	6 months	Determine the change in fatty acid composition in red blood cells
Hydroxylated omega-3 fatty acids in plasma	6 months	The change of hydroxylated omega-3 fatty acids in plasma
Omega-3 index with EASI parameters	6 months	The association of omega-3 index with EASI parameters

Trial Locations

Locations (1)

Helse Møre og Romsdal HF; 🇳🇴 Ålesund, Møre Og Romsdal, Norway