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

NCT07133477 | Recruiting

• 1 other identifier: AN3991
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Health

Keywords

skin; mono-unsaturated fatty acids; LCMUFA; omega-3

Outcome Measures

Primary Outcomes (2)

• Erythema

  1\. Facial erythema measured using the validated erythema image analysis algorithm within the quantitative measurement system of the Visia CRII image analysis system. Comparison of erythema area (pixels on erythema algorithm map) in pre and post analysis situations will be evaluated statistically for mean and median changes across the study cohort.

  3 months intervention

• Skin hydration

  2\. Transepithelial water loss will be measured using a non-invasive Tewameter. Values are given as g/m2/hour, higher values relate to increased water loss. Measurements will be made pre and post intervention (for doses together and separately) compared to placebo

  3 months intervention

Secondary Outcomes (2)

• Skin parameters, placebo adjusted

  3 months intervention

• Skin health by Omega-3 index

  3 months intervention

Study Arms (3)

Placebo

PLACEBO COMPARATOR

1g corn oil capsules

Dietary Supplement: Placebo

Low dose

EXPERIMENTAL

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

Dietary Supplement: Omega 3-9-11; Dietary Supplement: Placebo

High dose

EXPERIMENTAL

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

Dietary Supplement: Omega 3-9-11

Interventions

Omega 3-9-11 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.

High dose; Low dose

Placebo DIETARY_SUPPLEMENT

Corn oil capsules

Low dose; Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Epax Norway AS: lead
• Cutest Systems Ltd: collaborator

Study Sites (1)

Cutest Systems Ltd

Cardiff, United Kingdom

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will take a total of 4 capsules with a different ratio of fish oil and placebo according to which group they are selected for. Labelling is coded to maintain blinding.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects are randomised in a blinded fashion to one of 3 groups. Placebo, dose 1 and dose 2.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: August 21, 2025
• Study Start: April 30, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 1, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

GB (1)