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

A Randomized, Double-blinded Nutritional Study to Determine the Effect of a Concentrated Cetoleic Acid Fish Oil on Atopic Dermatitis

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Dietary supplement: LC-MUFA oil; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Kolden Midtbø, PhD; Phone Number: +47 70 11 16 00; Email: lisa.kolden.midtbo@moreforsking.no
• Study Contact Backup: Name: Jennifer Mildenberger, PhD

Study Locations

• Norway
  • Møre Og Romsdal
    • Ålesund, Møre Og Romsdal, Norway, 6017
      • Recruiting
      • Helse Møre og Romsdal HF
      • Contact: Dag Arne Lihaug Hoff

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LC-MUFA oil; 2x1g capsules containing concentrated marine oil from north atlantic fish	Dietary supplement: LC-MUFA oil; 2 x 1 g capsules containing marine oil from North Atlantic fish
Placebo Comparator: Placebo; 2x1g capsules containing corn oil	Dietary supplement: Placebo; 2 x 1 g capsules containing corn oil

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatty acid composition in red blood cells	Determine the change in fatty acid composition in red blood cells	6 months
Lipid compositions in skin	The change of ceramide/lipid composition in skin	6 months
Inflammation in skin	The change in inflammatory signalling molecules in skin	6 months
Blood lipids	The change in cholesterol/blood lipid profile	6 months
TEWL	The change in trans-epidermal water loss (TEWL)	6 months
Hydroxylated omega-3 fatty acids in plasma	The change of hydroxylated omega-3 fatty acids in plasma	6 months
Omega-3 index with EASI parameters	The association of omega-3 index with EASI parameters	6 months
Cetoleic acid with EASI parameters	The association of cetoleic acid content in RBCs with EASI parameters	6 months

Collaborators and Investigators

• Sponsor: Møreforsking AS
• Collaborators: University of Manchester; Helse Møre og Romsdal HF; Epax Norway AS
• Investigators: Principal Investigator: Dag Arne Lihaug Hoff, Helse Møre og Romsdal HF

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): October 10, 2024
• Study Completion (Estimated): October 10, 2024

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cetoleic acid; LC-MUFA; Ezcema; Nutritional study
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 589440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be presented as collective statistical data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No