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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-10-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions are given as 1g bovine capsules of equal size, weight and appearance, and provided in identical bottles with a coded label.

Study Groups

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LC-MUFA oil

2x1g capsules containing concentrated marine oil from north atlantic fish

Group Type EXPERIMENTAL

LC-MUFA oil

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

2x1g capsules containing corn oil

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

2 x 1 g capsules containing corn oil

Interventions

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LC-MUFA oil

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 x 1 g capsules containing corn oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No