Actively Recruiting

Phase Not Applicable
Age: 35Years - 65Years
All Genders
Healthy Volunteers
ID07133477

A Randomised, Placebo-Controlled Study to Evaluate the Effect of Fish Oil Concentrate on Skin Function

Led by Epax Norway AS · Updated on 2025-08-21

90

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

E

Epax Norway AS

Lead Sponsor

C

Cutest Systems Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a fish oil concentrate called EPAX Omega 3-9-11 on skin function. This study aims to determine if this combination of long chain mono-unsaturated fatty acids and omega-3 can improve skin health by reducing inflammation, redness, and improving the skin's barrier function. The research involves healthy adults aged 35 to 65 with a history of atopic skin prone to redness or dryness. Participants will be randomly assigned to one of three groups: a placebo group taking 1g corn oil capsules, a low dose group receiving 2g of Omega 3-9-11 oil, or a high dose group receiving 4g of Omega 3-9-11 oil daily. They will take these capsules for three months, with measurements taken at the start, 6 weeks, and 12 weeks. During the study, participants will undergo biophysical measurements of their face and inner forearm to assess skin erythema (redness) and hydration. Researchers will also monitor skin health through the Omega-3 index and other skin parameters adjusted for placebo effects. The study includes safety monitoring and requires participants to avoid other fish oil or lipid-based supplements during the trial. The total participation lasts three months, with evaluations at regular intervals.

CONDITIONS

Brief Title

A Study to Evaluate the Effect of Fish Oil Concentrate on Skin Function

Who Can Participate

Age: 35Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Volunteers who are able to provide signed informed consent
  • Healthy male or female volunteers between the ages of 35 and 65 years
  • Volunteers with a self-perceived history of atopic skin, prone to redness and/or dryness
Not Eligible

You will not qualify if you...

  • Females who are pregnant, breast feeding, or have given birth within the previous 6 weeks or are planning to be pregnant during the study
  • Volunteers with previous experience of intolerance or allergic reactions to fish or fish products
  • Volunteers with an active skin disorder or a significant history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of a trained assessor or dermatologist may affect the test results
  • Volunteers currently taking or who have recently taken antihistamines, antibiotics, systemic anti-inflammatory drugs during the previous week
  • Volunteers currently taking or who have recently taken retinoids, immunosuppressive drugs, anti-cancer drugs during the six previous months
  • Volunteers who have started, stopped or changed hormonal treatment (including contraceptive pills) in the five previous weeks
  • Volunteers whose skin has been exposed to excessive levels of sun or UV rays during the previous month
  • Volunteers who are suffering from chronic asthma, a malfunction of the lymphatic system, or an auto immune deficiency disease (e.g. lupus, thyroiditis)
  • Volunteers with a history of skin tumours or malignant disease
  • Volunteers who have participated in any clinical study involving the test sites within the previous month
  • Volunteers taking fish oil supplements or other lipid-based supplements regularly during the last 4 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months

Participants take fish oil or placebo capsules daily for 3 months and undergo skin function measurements.

1 baseline visit, 1 visit at 6 weeks, and 1 visit at 12 weeks

Trial Site Locations

Total: 1 location

1

Cutest Systems Ltd

Cardiff, United Kingdom

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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