NCT07133477

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Epax Norway AS · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	Placebo	Corn oil capsules

Timeline

• Start date: 2025-04-30
• Primary completion: 2025-09-30
• Completion: 2025-12-01
• First posted: 2025-08-21
• Last updated: 2025-08-21

Locations

1 site across 1 country: United Kingdom