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

NCT06194045 | Unknown

• 1 other identifier: 589440
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Cetoleic acid; LC-MUFA; Ezcema; Nutritional study

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Fatty acid composition in red blood cells

  6 months

• Lipid compositions in skin

  6 months

• Inflammation in skin

  6 months

• Blood lipids

  6 months

• TEWL

  6 months

Study Arms (2)

LC-MUFA oil

EXPERIMENTAL

2x1g capsules containing concentrated marine oil from north atlantic fish

Dietary Supplement: LC-MUFA oil

Placebo

PLACEBO COMPARATOR

2x1g capsules containing corn oil

Dietary Supplement: Placebo

Interventions

LC-MUFA oil DIETARY_SUPPLEMENT

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

LC-MUFA oil

Placebo DIETARY_SUPPLEMENT

2 x 1 g capsules containing corn oil

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Møreforsking AS: lead
• Helse Møre og Romsdal HF: collaborator
• Epax Norway AS: collaborator
• University of Manchester: collaborator

Study Sites (1)

Helse Møre og Romsdal HF

Ålesund, Møre og Romsdal, 6017, Norway

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dag Arne Lihaug Hoff

  Helse Møre og Romsdal HF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Kolden Midtbø, PhD

CONTACT

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

Jennifer Mildenberger, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Interventions are given as 1g bovine capsules of equal size, weight and appearance, and provided in identical bottles with a coded label.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 8, 2024
• Study Start: December 1, 2023
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: January 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)