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

N/AUnknownNCT06194045

Møreforsking AS60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

LC-MUFA oilDIETARY_SUPPLEMENT

2 x 1 g capsules containing marine oil from North Atlantic fish

PlaceboDIETARY_SUPPLEMENT

2 x 1 g capsules containing corn oil

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Helse Møre og Romsdal HF

Ålesund, Møre og Romsdal, Norway

RECRUITING

Outcomes

Primary Outcomes

EASI

Change in EASI (Eczema Area and Serverity Index) POEM).

Time frame: 6 months

DQLI

Change in DQLI

Time frame: 6 months

POEM

Change in POEM (Patient Oriented Eczema Measure)

Time frame: 6 months

Itch Numerical Rating Scale (NRS)

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).

Time frame: 6 months

Secondary Outcomes

Fatty acid composition in red blood cells

Determine the change in fatty acid composition in red blood cells

Time frame: 6 months

Lipid compositions in skin

The change of ceramide/lipid composition in skin

Time frame: 6 months

Inflammation in skin

The change in inflammatory signalling molecules in skin

Time frame: 6 months

Blood lipids

The change in cholesterol/blood lipid profile

Time frame: 6 months

TEWL

The change in trans-epidermal water loss (TEWL)

Time frame: 6 months

Central Contacts

Lisa Kolden Midtbø, PhD

CONTACT

+47 70 11 16 00 lisa.kolden.midtbo@moreforsking.no

Jennifer Mildenberger, PhD

CONTACT

Data from ClinicalTrials.gov

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