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

NCT ID: NCT07133477

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2025-12-01

Brief Summary

The primary objective of the study is to determine the benefits of the food product EPAX Omega 3-9-11 on skin function.

Benefits (if any) will be determined by evaluating biophysical measurements of the face and inner forearm. Moreover, the study will determine the dosage effect of Omega-3-9-11 on these measurements.

Detailed Description

The long chain mono-unsaturated fatty acids, cetoleic acid (C22:1 n-11) and gondoic acid (C20:1 n-9) found in some North Atlantic fish have been shown to lower inflammatory markers. This has been shown in preclinical studies with particular effect in adipose tissue, and in a human clinical study measuring redness of the face. Omega-3 is also known for reducing skin erythema evoked as a response to UVB exposure, and to decreasing systemic inflammatory biomarkers.

This provides a hypothesis that a combination oil with known bioaccumulation in both subcutaneous fat and in dermal/epidermal layers will contribute to healthy skin function, as shown by a reduction in inflammatory markers and skin erythema and improved barrier function.

The study will recruit subjects to one of 3 arms, a placebo, a low dose and a high dose of omega 3-9-11. Subjects will receive capsules for 3 months and undergo a series of measurements at baseline, 6 weeks and 12 weeks.

Conditions

Skin Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

1g corn oil capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Corn oil capsules

Low dose

Subjects will receive 2g of Omega 3-9-11 oil

Group Type: EXPERIMENTAL

Omega 3-9-11

Intervention Type: DIETARY_SUPPLEMENT

Fish oil capsules containing a fish oil concentrate from North Atlantic fish species containing EPA / DHA / cetoleic acid and gondoic in controlled amounts.

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Corn oil capsules

High dose

Subjects will receive 4g of Omega 3-9-11 oil

Group Type: EXPERIMENTAL

Omega 3-9-11

Intervention Type: DIETARY_SUPPLEMENT

Fish oil capsules containing a fish oil concentrate from North Atlantic fish species containing EPA / DHA / cetoleic acid and gondoic in controlled amounts.

Interventions

Omega 3-9-11

Fish oil capsules containing a fish oil concentrate from North Atlantic fish species containing EPA / DHA / cetoleic acid and gondoic in controlled amounts.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Corn oil capsules

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cutest Systems Ltd

UNKNOWN

Sponsor Role: collaborator

Epax Norway AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cutest Systems Ltd

Cardiff, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Senior Project Manager Senior Project Manager

Role: primary

reception@cutest.co.uk

+44 2920625686

Other Identifiers

AN3991

Identifier Type: -

Identifier Source: org_study_id